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Poster Blitz - Morning break Sunday

Sunday, October 13, 2024
10:00 - 10:30
Ito International Research Centre and Faculty of Engineering Building 2

Details

POSTER THEMES: Adherence, AI and machine learning, Asthma and copd, Autoimmune, Cardiovascular, Cost-effectiveness and economic evaluations, Covid-19, Diabetes and metabolic diseases, Drug safety, Drug utilization and adherence, Geriatric and frailty related studies, Health policy, Methods, Neurology


Speaker

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Prof Pengcheng Liu
China Pharmaceutical University

Assessment of new anti-cancer biological products approved through Priority Review in China

Abstract

Introduction In recent years, the rapid development of biotechnology has made biologics a focal point for research and development by pharmaceutical companies, due to their high specificity and relatively low toxicity and side effects. In 2020, China introduced the latest version of the Drug Registration Regulation, optimizing regulatory processes for innovative biologics by establishing a priority review program to accelerate market access and better fulfill clinical demands.
Aims This study examined the differences in time to approval, efficacy, and safety between priority review and non-priority review anti-cancer biological products approved by China’s National Medical Products Administration (NMPA) during the same period.
Methods We analyzed all innovative anti-cancer therapeutic biological products approved by the NMPA between January 1, 2015, and December 31, 2023, using a public database. Development and Biologics License Application (BLA) approval times for priority and non-priority reviewed antineoplastic biologics were compared using the Mann-Whitney U test and T-test. A meta-analysis was performed to pool hazard ratios for progression-free survival (PFS), response rates (RR) from single-arm trials, rates of treatment-related serious adverse events, and rates of Grade ≥3 adverse events.
Results Out of 14 innovative biologics corresponding to 25 indications approved during the study period, the drug development time (2.83 vs. 2.95 years, p=0.996) and BLA approval time (321 vs. 403 days, p=0.211) for priority-reviewed biologics were numerically shorter than for non-priority reviewed biologics. There were no significant differences in RR in single-arm trials (41.5% vs. 55.6%, p=0.576). However, priority-reviewed biologics were more likely to have a Grade ≥3 adverse reaction rate (36% vs. 20%, p=0.003) and a treatment-emergent serious adverse reaction rate (20% vs. 8%, p=0.001).
Discussion/Conclusion Priority review biologics were associated with faster approval times but had a higher likelihood of adverse reactions. However, there was no statistically significant efficacy advantage over non-priority review biologics.

Biography

Positions: • Director of the Department of Pharmaceutical Regulatory Affairs, School of International Pharmaceutical Business, China Pharmaceutical University • Distinguished Expert at the National Medical Products Administration Institute of Executive Development • Member of Expert Panel for Reviewing Urgently-needed Clinical Medicines and Medical Devices Imported from Hong Kong and Macao in the Guangdong-Hong Kong-Macao Greater Bay Area (Mainland China) • Member of Committee of Evidence-Based Pharmacy, Chinese Pharmaceutical Association • Peer Reviewer for journals such as BMC Neurology, China Pharmacy, and Chinese Journal of New Drugs and Clinical Remedies • Adjunct Position at the Division of Development Strategy, Bureau of Planning and Policy, National Natural Science Foundation of China (2023-2024) • Deputy Director of the International Science and Technology Innovation Center, Suzhou Industrial Park Administrative Committee (2015-2017) • Science and Technology Talent Advisor for Suzhou, Jiangsu Province (2018-2021) Research Interests: • Drug regulatory science • Health insurance • Real-world studies Academic Achievements: • Chief (or co-) editor of textbooks including Theory and Practice of Chinese Pharmaceutical Law and Introduction to Pharmacy • Published over 30 academic papers in journals indexed by SCI, SSCI, CSSCI, and CSCD • Led or participated in over 30 research projects funded by entities such as the National Healthcare Security Administration, the Ministry of Finance of the People’s Republic of China, the National Medical Products Administration, Center for Drug Reevaluation, the Young Talent Program of Jiangsu Science and Technology Think Tank, and the Philosophy and Social Science Fund of Jiangsu Provincial Universities
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Professor Masato Takeuchi
Shizuoka Graduate University of Public Health

Safety of SGLT2 inhibitors in type 1 diabetes: real-world experience in Japan

Abstract

Introduction
Sodium-glucose cotransporter 2 (SGLT2) inhibitors may be prescribed as “off-label” adjunct therapies for type 1 diabetes mellitus (T1DM). Japan is one of the few countries where two SGLT2 inhibitors—dapagliflozin and ipragliflozin—have received regulatory approval for use in patients with uncontrolled T1DM. Concerns remain regarding the safety of SGLT2 use among T1DM patients.

Aims
To investigate the safety profile of SGLT2 inhibitor therapy among T1DM patients in a real-world setting.

Methods
We analyzed data from the RWD database, a multihospital database that contains patient data from 230 institutions across Japan. We selected patients with T1DM who initiated treatment with either dapagliflozin or ipragliflozin after regulatory approval, with regular care for T1DM at medical institutions participating in the RWD database. Prespecified adverse events included acute kidney injury, hypoglycemia, amputation, ketoacidosis, urinary tract infection (UTI), genital infection, and non-vertebral fracture. The newly recorded diagnoses of the aforementioned events were identified from the initiation of SGLT2 inhibitors to the last prescription date, including the days covered by the last pills.

Results
From 13, 848 patients with T1DM, we identified 393 initiators of SGLT2 inhibitors after regulatory approval; the details of patient characteristics and glycemic control dynamics are reported in 2024 ISPE Annual Meeting. The median age was 51 years (interquartile range: 42 to 63), and females accounted for 55.7%. During a total of 10,650 person-months of follow-up, 48 patients (12.2% or 4.5 cases per 1000 person-months) had at least one record of prespecified adverse events. The most common adverse event was hypoglycemia, occurring in 19 patients (4.8%), followed by UTI (4.1%) and ketoacidosis (2.3%); no records of limb amputation or non-vertebral fracture were documented.

Conclusion
Despite the limited sample size, our data offer insights regarding the safety profile of SGLT2 inhibitors when they have an expanded "on-label" indication for T1DM.

Biography

Prof. Takeuchi received an MD degree from Nagoya City University and received MPH and PhD degrees from the University of Tokyo. His professional career started as pediatrician, followed by academic physician and researcher. His research interest is epidemiology—such as clinical epidemiology or pharmacoepidemiology—utilizing large healthcare databases (often referred to as “big data”). He is also interested in longitudinal data analysis, causal inference, machine learning, and the combined use of these methods.
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Jeslin Theres Thomas
Student
JSS College of Pharmacy, Mysuru

Development and validation of medication adherence questionnaire for patients with chronic illnesses in Southern India

Abstract

Introduction. Assessing medication adherence is a big concern in the healthcare system. Different methods help to access medication adherence, but it is limited to certain diseases. Newly validated medication adherence questionnaire mainly focuses on patients with hypertension, diabetes, and asthma for assessing medication adherence.
Aims. To validate the newly developed medication adherence questionnaire for patients with chronic diseases in Southern India.
Methods. An extensive literature search was conducted from search engines using MeSH terms for the development of medication adherence questionnaire. The questions are designed to identify the barriers to medication adherence if the patient is not adherent to their prescribed regimen (The validated and developed questionnaire is mentioned below. Table 1). These are 8-component questions, a patient is considered adherent if the score falls < 4 and non-adherent The developed adherence questionnaire was subjected to validation with a team of 20 experts from community pharmacists, professors, associate professors, assistant professors, and lecturers from the department of clinical pharmacy. The experts are asked to rate the questions based on relevance, clarity, simplicity, and ambiguity on a scale from one to four, with four being the highest score. I-CVI and S-CVI scores for the questionnaire are above 80% and the internal consistency measured using Cronbach alfa is 0.90.
Results. The I-CVI and S-CVI scores for the questionnaire are above 80% and the internal consistency with the parameters consisting of relevance, clarity, simplicity, and ambiguity are measured using Cronbach alpha and the average is 0.90, therefore, the questionnaire is considered ‘excellent.
Discussion. The newly developed and validated questionnaire is useful in assessing patient-reported medication adherence because of its accuracy, sensitivity, and ease of use. The MAQ's data analysis gives helpful insights into how well people follow their treatment and help them if they need it, possibly predicting outcomes better than other evaluating tools. Implementing such medication adherence questionnaires helps healthcare professionals understand the extent of adherence in patients and they can aid in improving patient outcomes.

Abstract Document

Biography

Jeslin Theres Thomas, a dedicated pharmacy professional, holds a Bachelor of Pharmacy degree and has extensive experience in the field. Her project on the estimation of organophosphate compound cypermethrin showcases her expertise in analytical chemistry. Currently, she is interning at JSS Hospital in Mysore while pursuing her Doctor of Pharmacy degree as a post-baccalaureate student. She has already demonstrated her passion for innovation and strong desire through her remarkable achievements. One of her most significant accomplishments is developing the Medstik tool, which has earned copyright approval. Medstik is a unique and innovative solution designed to enhance patient medication adherence. This achievement showcases her talent and hard work, as well as her ability to contribute to the healthcare industry. It demonstrates her commitment to making a positive impact on the industry. As she continues to grow and develop her expertise and make many more positive impacts in healthcare.
Yulin Wang
Peking University

A Comparative Review of International Common Data Models for Vaccine Safety

Abstract

Background:The Common Data Model(CDM) is crucial for integrating multi-source heterogeneous data and supporting big data analysis for vaccine safety.
Aims:To review the key elements and technical characteristics of CDMs, providing a reference for constructing a localized CDM system for vaccine safety evaluation.
Methods:A systematic review was conducted using search strategies based on "vaccine safety" and "CDM" themes in databases like PubMed and Embase, supplemented by global surveillance platforms. Key information from identified CDMs'official documents was extracted for a systematic comparison of model overview, data structure, and ETL tools.
Results:The CDMs currently used in vaccine safety monitoring include OMOP, Sentinel, PCORnet, ADVANCE, VAESCO, and BIFAP. Technical details of ADVANCE, VAESCO, and BIFAP were not accessible:(1) Model Overview: OMOP, Sentinel, and PCORnet developed with input from regulatory agencies, healthcare institutions, and academia, These models have been updated more than ten times since their inception to expand the scope of terminology mapping, address COVID-19 data aggregation, and other reasons. (2)OMOP has 39 relational model tables, Sentinel has 20 star schema tables, and PCORnet has 23 core star schema tables with new data dimensions like patient-reported outcomes. OMOP disperses vaccine data across multiple tables, while Sentinel and PCORnet centralize immunization records.(3)ETL Process: All three CDMs emphasize standardized, traceable ETL steps and full-process quality control. OMOP uses unified standard concept systems(e.g., SNOMED CT, RxNorm) for semantic mapping to enhance interoperability; Sentinel and PCORnet balance standard vocabularies with industry codes(e.g., ICD, NDC), reducing mapping workload but facing terminology integration challenges. OMOP supports open-source ETL tools like Rabbit in a Hat; Sentinel has a comprehensive SAS package; PCORnet lacks dedicated ETL tools.
Conclusion:A localized CDM should be based on vaccine regulatory needs, leveraging international experience to enhance system specifications, optimize data collection, and develop ETL solutions. Multi-party collaboration can establish a CDM system suited to national conditions.

Biography

Wang Yulin is a master degree student at the School of Public Health, Peking University, specializing in Epidemiology and Biostatistics. His primary research areas include pharmacoepidemiology.
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Mrs. Wen-Li Kuan
Master student
National Taiwan University

Adherence Trajectories to Aromatase Inhibitors in Postmenopausal Breast Cancer: A Five-Year Study

Abstract

-Introduction:
For postmenopausal women with hormone receptor-positive breast cancer, a five-year course of aromatase inhibitor (AI) is considered an optimal choice due to its efficacy, side effect profile, and reduction in recurrence rates. However, maintaining adherence remains a significant challenge in clinical settings.
- Aims:
This study aims to identify distinct adherence trajectory groups among nonmetastatic patients receiving AI therapy and to determine the associated factors.
-Methods:
We utilized data from Taiwan's National Health Insurance Research Database and National Cancer Registry, identifying hormone receptor-positive postmenopausal women newly diagnosed with stage 1-3 breast cancer who initiated AI therapy after surgery. Medication adherence was calculated using the monthly proportion of days covered and conducted. A five-year cohort study on adherence trajectories was conducted using group-based trajectory modeling. Multinomial logistic regressions were employed to identify factors associated with different trajectories.
- Results:
The analysis included 4760 women, and a five-trajectory model was determined based on Bayesian information criterion (BIC) and fitness criteria. The identified trajectories were: continuous optimal adherence (34.2%, n=1639), continuous suboptimal adherence (47.3%, n=2271), progressive nonadherence then discontinuation (7.3%, n=322), early nonadherence then discontinuation (5.4, n=256%), and immediate discontinuation (6.0%, n=272). Factors linked to nonadherence included age over 80, higher comorbidity burden, use of chemotherapy, and residing in northern regions.
-Discussion:
This study identifies potential factors related to medication adherence trajectories among breast cancer patients receiving AI treatment in Taiwan. These findings provide direction for healthcare professionals to develop interventions to improve medication adherence. Future research should investigate the impact of adherence trajectories on clinical outcomes.

Biography

I am a master's student at the Clinical Pharmacy Graduate Institute of National Taiwan University, making my first submission to an international conference. Previously, I worked as a hospital pharmacist, focusing on medication safety and correct usage, promoting public health awareness, and educating on proper medication practices. During my studies, I have researched the impact of medication adherence on patient health. At this conference, I am presenting my first study on the medication adherence trajectories of Taiwanese postmenopausal patients with non-metastatic breast cancer using aromatase inhibitors. This research aims to understand the reasons for poor adherence and provide insights for clinical improvement.
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Yen Ling Koon
Health Sciences Authority

Comparative evaluation of generative large language models in adverse drug reaction prediction

Abstract

Introduction:
The advent of large language models (LLMs) in generative AI has transformed text processing, but their potential for identifying adverse drug reactions (ADRs) from clinical text remains unexplored. Identifying ADRs from clinical text demands intricate cause-and-effect assessment and relation extraction. It remains uncertain if generative LLMs can effectively tackle such complex tasks.

Aims:
This study aims to assess the performance of generative LLMs in detecting ADRs from unstructured clinical text containing causally linked drug-adverse event pairs.

Methods:
Various generative LLMs are tested in their ability to correctly classify ADRs from text segments in the Medical Information Mart for Intensive Care (MIMIC-III) dataset (n=4418). LLMs are prompted to generate a probability score for each specific drug-adverse event pair in the text segment to indicate the likelihood of an ADR being present. We use F1 score to evaluate the performance of LLMs based on these probabilities. Furthermore, we benchmark the performance of generative LLMs against our in-house fine-tuned BioM-ELECTRA-large model, a LLM designed for biomedical text analysis and fine-tuned for ADR classification, to provide a comprehensive comparison of their abilities in detecting ADRs from clinical text.

Results:
Despite lacking prior training on ADR classification, Gemini 1.5 Pro and Claude 3 Opus demonstrated F1 scores comparable to BioM-ELECTRA-large (0.86, 0.78, and 0.72 for Gemini 1.5 Pro, Claude 3 Opus, and BioM-ELECTRA-large, respectively). Generative LLMs exhibited higher recall but lower precision, indicating a trade-off where LLMs captured a wider range of ADRs but with higher false positive. To address this trade-off, a hybrid framework is proposed to combine BioM-ELECTRA-large's precision with generative LLMs' recall capabilities for high-performance ADR prediction while optimizing computational costs.

Conclusion:
This study enhances the understanding of generative LLMs in ADR detection and introduces a pioneering hybrid framework for balancing performance and computational resource allocation in ADR prediction systems.

Biography

Dr. Koon is a computational biologist with a Ph.D. from Nanyang Technological University, conferred in 2018. Following her doctoral studies, she pursued a postdoctoral position at A*STAR, gaining valuable experience in bioinformatics and data analysis. Subsequently, Dr. Koon joined an A*STAR spin-off, where she worked as a bioinformatician and data analyst, specializing in transcriptomic and sequencing data. For the last two years, she has been applying her expertise at the Health Sciences Authority (HSA), contributing to the data analytics team's efforts to examine adverse events following COVID-19 vaccination, with a specific emphasis on appendicitis. Currently, her primary focus lies in monitoring adverse events following childhood vaccination.
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Ph.d Kenji Momo
Associate professor
Showa University

Statin Medication Adherence in Relation to Dyslipidemia Risk Categories

Abstract

Introduction: Ensuring medication adherence to statins, a key drug for the prevention of cardiovascular disease, is an important issue. However, the extent of medication adherence to statins is not fully understood.
Aim: This study aims to clarify the medication adherence to statins based on the risk category of dyslipidemia.
Methods: We used administrative claims data obtained from the Japan Medical Data Centre (JMDC). Out of 174,941 patients who initiated statin therapy, we excluded those without 3 months of screening and 12 months of observation periods. Finally, we analyzed 81,596 patients. Medication adherence was assessed using the Proportion of Days Covered (PDC) method, with a cut-off value set at 80% PDC. The risk categories for dyslipidemia were referred to the 2017 Japan Atherosclerosis Society (JAS) guidelines for the prevention of atherosclerotic cardiovascular diseases.
Results: Among our study patients, 91% used statins for primary prevention (n=74,363). In this group, 26.9% were classified as high risk (n=20,016). Medication adherence exceeding 80% was observed in 63.6% (12,726/20,016) of these high-risk patients. The proportion of patients with medication adherence over 80% was similar between those administered high-intensity statins and those on low-intensity statins.
Discussion /Conclusion: Our study found that medication adherence to statins is approximately 60% in patients using statins for primary prevention of cardiovascular disease. Generally, maintaining Low-Density Lipoprotein Cholesterol (LDL-C) at adequate levels requires over 80% medication adherence to statins. Our study highlights the importance of educating patients on the necessity of maintaining high medication adherence to achieve optimal therapeutic outcomes with statin therapy.

Biography

Kenji Momo is an associate professor of the Department of Hospital Pharmaceutics, School of Pharmacy, Showa University, Tokyo, Japan. His expertise is pharmacoepidemiology, drug development, and clinical pharmaceutics. He studied at the Department of Nephrology, Karolinska Institutet, Stockholm, Sweden during 2022 to 2023. He learned medical big data at Sweden,
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Tong Li
Global Epidemiology, Janssen Research & Development, LLC

Real-world persistence with second-line IL-17i and IL-23i treatment for psoriasis in Japan

Abstract

Introduction: In patients with plaque psoriasis (PsO), second-line biologic use follows first-line biologic failure, but evidence on second-line biologic experience is still largely lacking.

Aims: This study describes second-line biologic persistence in patients with PsO in Japan.

Methods: This retrospective cohort study used the Japanese Medical Data Vision database containing hospital-based claims data on 46 million patients in Japan. Study population included adults who used IL-17 inhibitors (IL-17i) or IL-23 inhibitors (IL-23i) as second-line biologic treatment for PsO (ICD-10=L40.0) between 01 January 2015 and 31 December 2022. Persistence was measured from the time of initiating second-line biologic to discontinuation, switch to another biologic, loss to follow-up or study end, whichever came first. Discontinuation was defined as a treatment gap of at least twice the biologic-specific maintenance dosing interval (IL-17i: 8 weeks for secukinumab and ixekizumab, 4 weeks for brodalumab; IL-23i: 16 weeks for guselkumab, 24 weeks for risankizumab and tildrakizumab). Persistence rate was estimated by the proportion of patients continuing second-line biologic at 6-, 12-, and 24-months after initiation. Median (IQR) persistence and persistence rates with 95%CI were reported for the IL-17i and IL-23i groups.

Results: In total, 311 PsO patients received second-line biologic during the study period; 48.6% (n= 151) received an IL-17i, and 51.4% (n=160) received an IL-23i. For patients receiving second-line IL-17i, median persistence was 5.5 (2.8-14.4) months and persistence rates at 6-, 12-, and 24-months were 61.5% (52.5-69.9%), 48.9% (39.0%-59.0%) and 33.3% (23.4-45.1%), respectively. For patients receiving second-line IL-23i, median persistence was 8.6 (4.6-20.1) months and persistence rates at 6-, 12-, and 24-months were 80.9% (73.4-86.7%), 63.6% (53.8%-72.4%) and 51.7% (39.3-63.8%), respectively.

Discussion/Conclusion: In this study, persistence was longer for IL-23i than IL-17i as second-line treatment for PsO in Japan, consistent with previous findings for first-line use.

plaque psoriasis; interleukin-17 inhibitor; interleukin-23 inhibitor; second-line biologic persistence.

Biography

I am Tong Li, an epidemiology scientist focused on the real-world epidemiology studies. I’ve been doing this for 4 years. I have accomplished several analysis work and publications in real-world studies. My love for contributing to human health pushes me to get better. I wish to apply my knowledge into improving human health in clinical practice.
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Wei KANG
The University of Hong Kong

Systematic review and meta-analysis of DOACs versus LMWH in Cancer-Associated venous Thrombosis

Abstract

Introduction: Cancer-associated venous thrombosis (CAT) is a condition associated with high mortality rates. However, limited evidence exists regarding the effectiveness and safety of low-molecular-weight heparin (LMWH) and direct oral anticoagulants (DOACs) for its treatment.
Aims: Using data from multiple clinical and real-world studies, we conducted a systematic review and meta-analysis to compare the effectiveness and safety of DOACs to LMWH in patients with CAT.
Methods: We conducted a systematic search of PubMed, Embase, and Cochrane Library databases up to May 31, 2023, for relevant randomized controlled trials (RCTs) and cohort studies comparing DOACs to LMWH in patients with CAT. Two reviewers independently screened the studies, assessed the risk of bias, and extracted data. Meta-analyses were performed separately for RCTs and cohort studies with a specified 6-month follow-up period. Risk ratios (RRs) were calculated and pooled using the random-effects model.
Results: The systematic review included five RCTs and 20 cohort studies. After applying the six-month follow-up criterion, 17 articles with a total of 22,941 patients were analyzed in the meta-analysis. In RCTs, DOACs were associated with a lower risk of VTE recurrence (RR 0.66, 95% CI 0.49-0.87) compared to LMWH, with no significant differences in major bleeding (RR 1.31, 95% CI 0.85-2.03) and all-cause mortality (RR 0.99, 95% CI 0.84-1.71). Cohort studies showed a lower risk of VTE recurrence (RR 0.71, 95% CI 0.62-0.80) with DOACs, no significant difference in major bleeding (RR 0.89, 95% CI 0.65-1.22), and a reduced risk of all-cause mortality (RR 0.46, 95% CI 0.25-0.85).
Conclusions: The findings from both RCTs and cohort studies indicate that DOACs significantly reduce the recurrence of VTE in patients with CAT without increasing the risk of major bleeding or all-cause mortality compared to LMWH. These results suggest that DOACs may provide a superior anticoagulation effect for CAT compared to LMWH.

Biography

Wei KANG joined the Centre for Safe Medication Practice and Research at the University of Hong Kong as a PhD student in 2020. Her research lies in the fields of pharmacoepidemiology and health economics. Her primary focus is on leveraging real-world data to address cancer-related challenges, including the effectiveness, safety, and economic burden of anticoagulants for patients with cancer-associated thrombosis. She also seeks to understand disease burdens and vaccine safety for patients with cancer. Over the past few years, she has published numerous papers in reputable journals.
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Indriastuti Cahyaningsih
Universitas Muhammadiyah Yogyakarta

Knowledge, medication beliefs and adherence in diabetes patients: A structural equation modelling

Abstract

Introduction: Non-adherence to glucose-lowering medications is a crucial problem in type 2 diabetes (T2D) patients. Diabetes knowledge and medication beliefs including beliefs about natural remedies are likely associated with medication adherence. Studies investigating the relationship between medication adherence and those factors are a good basis to develop intervention improving medication adherence.
Aims: To determine associations between patient characteristics, diabetes knowledge, beliefs about medication, beliefs about natural remedies and medication adherence to glucose-lowering medications.
Methods: This was a multicentre cross-sectional study which was conducted in sixteen primary health care centres in Indonesia. T2D patients, aged above 18 years who were willing to participate were included in the study. Adapted diabetes knowledge questionnaire (DKQ), beliefs about medications questionnaire (BMQ) and medication adherence rating scale-5 (MARS-5) were used as assessment tools. Structural equation modelling was used to analyse the data.
Results: This study included 328 T2D patients (mean age 60.6±8.9, female 74.4%, mean duration of diabetes 7.1±6.2). The final model (CFI: 0.916; RMSEA: 0.057; SRMR: 0.055) indicated that beliefs about glucose-lowering medications in terms of necessity (B=0.152), overuse (B= -0.216) and side effects (B= -0.108) were significantly associated with medication adherence. Additionally, taking natural remedies was also significantly associated with medication adherence (B= -0.139).
Discussion: The findings demonstrate that patients are more likely to adhere to their medication when they believe the medicines are important, not overused, and not harmful. People who are natural remedy users may have lower adherence to prescribed medications. Somewhat surprisingly, knowledge about diabetes did not make a difference in adherence.

Biography

I am a PhD student in Unit of Pharmacotherapy, Epidemiology and Economics, University of Groningen. I have several experiences in conducting research related to pharmacotherapy and pharmacoepidemiology.
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Mr. Zhen Han Oh
Doctor
Shuangho hospital ministry of health and welfare

Trends in Obstructive Sleep Apnea incidence in Taiwan from 2004 to 2020

Abstract

Introduction
Obstructive Sleep Apnea (OSA) has rapidly increased in Taiwan and is linked to higher comorbidities and mortality. Therefore, updating nationwide trend analyses of OSA incidence is crucial for informing clinical management strategies.
Aims
To determine the trends in incidence of diagnosed OSA in Taiwan from 2004 to 2020.
Methods
A retrospective nationwide longitudinal study was conducted using data from Taiwan's National Health Insurance Research Database collected from 2004 to 2020. Newly diagnosed cases of OSA were identified using the International Classification of Diseases diagnostic codes. OSA incidence patients were defined as those with their first OSA diagnosis between 2004 and 2020, confirmed by a polysomnography (PSG) procedure within one year prior to diagnosis, and without prior OSA diagnosis before 2004. The incidence rates were categorized into eight age groups: 0-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years, and age-adjusted incidence rates were presented by calendar year.
Results
From 2004 to 2018, the incidence rate increased annually, peaking at 95.14 per 100,000 person-years in 2018, before starting to decline in 2019 and 2020. Men are more than twice as likely to develop OSA as women. The incidence of OSA was generally higher among people aged 40 to 69 years than in other age groups. When 2007 data was used as a baseline, the relative incidence ratio for those aged 20-29 and 30-39 years in 2020 was 2.50 and 2.04, respectively, indicating that young adults aged 20-39 years saw the largest increase in incidence.
Discussion/Conclusion
This study shows that the incidence of OSA is significantly rising in Taiwan, affecting both genders and all age groups. Middle-aged people had the highest incidence, while younger people showed higher rising trends in the incidence of OSA. The elderly's relatively low incidence of OSA suggests that it may have been underestimated.

Biography

My name is Oh Zhen Han. I graduated from Taipei Medical University with a Bachelor's degree in Medicine. I am currently working as a resident in the Family Medicine department at Shuang Ho Hospital.
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Qiuyan Yu
University of Hong Kong

Trend of treatment patterns and lipid control for primary prevention of ASCVD

Abstract

Introduction
Evidence on treatment patterns and lipid control for primary prevention of atherosclerotic cardiovascular disease (ASCVD) in Hong Kong (HK) is limited. During the COVID-19 pandemic, it is important to investigate the prescribing patterns of lipid-lowering medication (LLM) and lipid control impacted by the pandemic and COVID-19 vaccination programme (CVP).
Aims
To estimate the prescribing trend of LLM and mean low-density lipoprotein cholesterol (LDL-C) level among patients with primary prevention of ASCVD.
Methods
Electronic health records database from the Hospital Authority in HK was used. We extracted relevant data to identify LLM and LDL-C levels between January 2020 and 31 August 2023. We extracted a cohort of primary prevention for ASCVD, defined as patients without any ASCVD diagnosis but receiving LLM in 2016-2019 and those who received LLM before their first ASCVD diagnosis in 2020-2023. We applied interrupted time series (ITS) analysis to assess the trend of monthly proportion of LLM prescriptions and mean LDL-C level before and after CVP and the fifth wave COVID-19 pandemic.
Results
The monthly proportions of LLM prescriptions fluctuated from 3.29% to 5.18%, while the monthly mean LDL-C levels fluctuated from 2.06 to 2.28 mmol/L for the patients with primary prevention of ASCVD. In the ITS analysis, no immediate change or change in the trend of the proportion of LLM after CVP were observed, while we found a marginal increase in the immediate change of monthly mean LDL-C levels (0.056, 95%CI: 0.002,0.110) after CVP. We observed a decrease in the immediate change of the proportion of LLM (-0.369, 95%CI: -0.691,-0.046), and a slight decrease in the trend of the monthly mean LDL-C levels (-0.007, 95%CI: -0.011,-0.003) after the fifth wave COVID-19 pandemic.
Conclusion
The findings indicated the latest real-world practice of prescribing trends in LLM and lipid control among patients with primary prevention of ASCVD.

Biography

A PhD candidate at the University of Hong Kong with a research area in pharmacoepidemiology.
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Dr. Yang Xu
Peking University Health Services Centre

Statins and intracerebral hemorrhage risk: a target trial emulation study in China

Abstract

- Introduction
Statin has been shown to prevent major vascular events in a wide range of individuals, but the risk of intracerebral hemorrhage (ICH) from statin use remains unclear.
- Aims
To evaluate the impact of statins on the risk of ICH in Chinese population.
- Methods
Using 2011-2020 year data from the Yinzhou Regional Health Care Database (YRHCD), patients aged 50 years or older with no history of ICH and statin use were included. In the framework of target trial emulation. 60 sequential target trials were emulated each month from 2011 to 2015. Within each trial, patients were categorized as statin initiators or non-initiators based on their first prescription during the one-month enrollment period. Patients in different groups of each emulated trial were matched using propensity scores (PS) and then stacked together into one dataset. On this dataset, Cox proportional hazards model was used to estimate the effect of statin on ICH risk.
- Results
53,413 statin initiators and 35,033,455 non-initiators from 60 emulated trials were included into analysis. After PS matching, with a median follow-up of 6.83 (interquartile range 5.67-8.17) years, the hazard ratio of ICH of statin initiators compared with non-initiators was 1.25 (95% confidence interval: 1.09-1.43). The results are consistent across multiple subgroups and sensitivity analyses.
- Discussion/Conclusion
Increased ICH risk was found for ICH-free patients when they received statin treatment.

Biography

Certainly, here's the paragraph with corrected grammar: Dr. Yang Xu is an Assistant Professor at the School of Pharmaceutical Sciences, Peking University Health Science Center in China. With a background in epidemiology and biostatistics, Dr. Xu's research focuses on causal inference in real-world evidence-based studies. He uses observational study designs and data-driven methods to minimize the risk of confounding and bias. His work, which centers around drugs and renal diseases, covers populations in China and Sweden and has been published in reputable journals such as Diabetes Care, Kidney International, and Pharmacoepidemiology and Drug Safety. Additionally, he is a member of the China Primary Health Care Foundation Associate and has received grants from the National Natural Science Foundation.
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Hwa Yeon Ko
Sungkyunkwan University

Sodium-glucose cotransporter 2 inhibitors and cardiovascular events across body mass index

Abstract

-Several studies have shown significant reductions in major adverse cardiovascular events (MACE) and heart failure (HF) with sodium-glucose cotransporter 2 inhibitors (SGLT2i); however, there is insufficient evidence to determine whether these reductions are not modified in populations stratified by body mass index (BMI).
-To assess whether stratification by baseline BMI modifies the measures of association between SGLT2i and the risk of MACE and HF compared to dipeptidyl-peptidase 4 inhibitors (DPP4i) among patients with type 2 diabetes (T2D).
-We used nationwide claims data of Korea (2010.01-2022.12) to construct active comparator, new-user cohort of T2D patients stratified by Asian BMI categories: Normal, 18.5 to <23 kg/m2; Overweight, 23 to <25 kg/m2; Obese, ≥25 kg/m2. New users of SGLT2i were 1:1 propensity score (PS)-matched with new users of DPP4i. The co-primary outcomes were 4-point MACE and hospitalization for HF. Patients were followed using an as-treated exposure definition. PS-matched hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox models.
-New users of SGLT2i and DPP4i were 1:1 PS-matched (n=231,332 pairs; obese 174,675 pairs, overweight 35,372 pairs, and normal weight 21,285 pairs). The overall hazard ratio (HR) for the risk of MACE with SGLT2i vs. DPP4i was 0.90 (95% CI 0.86-0.95) with no evidence of effect modification by baseline BMI (p for homogeneity: 0.32). The risk of HF decreased in total cohort (0.53, 0.44-0.63), obese (0.47, 0.37-0.58) and overweight (0.49, 0.31-0.78) groups, but not in normal (0.86, 0.58-1.29) group, with evidence of effect modification by BMI (p for homogeneity: 0.01).
-SGLT2i improved 4-point MACE compared to DPP4i regardless of BMI status, while the decreased risk of hospitalization for HF was modified by BMI. Normal weight patients presented no significant reduction in the risk of HF, suggesting a potential role of body weight in the underlying mechanism by which SGLT2i improve heart failure.

Biography

Hwa Yeon Ko received PharmD at School of Pharmacy, Sungkyunkwan University in February 2022. She is now a PhD student at Department of Pharmacoepidemiology and Pharmacovigilance, School of Pharmacy, Sungkyunkwan Univeristy. Her research interests are pharmacoepidemiology, particularly in generating safety evidence for antihyperglycemic agents in vulnerable populations or patients with chronic comorbidities.
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Professor Zhen-Fang Lin
National Taiwan University

Risk of Stroke Associated with NSAID among Osteoarthritis Patients with Atrial Fibrillation

Abstract

Introduction
A great amount of studies imply that the NSAIDs(non-steroidal anti-inflammatory drug)including COX-2 inhibitors(selective inhibitors of cyclooxygenase-2)and traditional NSAIDs are related to higher risk of vascular events such as myocardial infarction, thromboembolism and stroke. In addition, atrial fibrillation may also increase the opportunity to cause vascular events. Stroke would lay a serious burden on medical care system. Consequently, establishing the safety profile of NSAIDs is necessary.
Aims
This study aims to clarify the association between risk of ischemic stroke and use of non-aspirin NSAIDs in osteoarthritis (OA) patients with non-valvular atrial fibrillation.
Methods
A retrospective cohort study is devoted on the analysis of Taiwan National Health Insurance Database. Persons were eligible if they had diagnosis for OA with atrial fibrillation. A total of 3826 patients were included in the study. The endpoint was defined as ischemic stroke. The hazard ratio (HR) and 95% confidence interval of outcomes were calculated by cox regression models.
Results
In demographic analysis, diclofenac accounted for 28.5% and celecoxib accountd for 13.5% among all NSAIDs prescriptions in user group. Compared to non-user, some drugs were associated with increased risk of ischemic stroke such as etoricoxib (adjHR=1.897; 95%CI=0.682-5.281), diclofenac (adjHR=1.462; 95%CI=0.837-2.553), meloxicam (adjHR=1.111; 95%CI=0.63-1.958), ibuprofen (adjHR= 1.497; 95%CI= 0.365-6.152). Especially, celecoxib (adjHR=1.879; 95%CI=1.003-3.522) show higher and statistically significant risk of ischemic stroke.
Discussion/Conclusion
Our study finds that in OA patients with non-valvular atrial fibrillation, celecoxib was related to higher risk of ischemic stroke. In contrast, naproxen was associated with decreased risk. Further research is needed to clarify the relationship between NSAIDs and ischemic stroke risk.



Biography

Zhen-Fang Lin graduated from School of Pharmacy, National Taiwan University in 1994 and serve as teaching assistant for one year. She has completed her MPH degree from School of Public Health, University of Minnesota in the United States. During 1997-2012, she serves as a clinical pharmacist and section chief of teaching & research of the pharmacy department at the medical center. She has completed her Ph.D. degree from National Taiwan University in 2012. Her research and teaching interest includes the safety and effectiveness of pharmacotherapy in patients with cardiovascular and other diseases, public health in pharmacy, and new uses for old drugs.
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Dr Zixuan Wang
London School of Hygiene and Tropical Medicine

Risk of cancer comparing warfarin and direct oral anticoagulants

Abstract

Introduction: Previous evidence suggests a potential protective effect of warfarin against cancer, compared to non-users. However, it may be prone to immortal time bias and residual confounding.
Aim: To investigate the association between warfarin and hazard of cancer (any cancer and 16 most common site-specific cancers including female breast, prostate, colorectum, lung, bladder, stomach, oesophagus, non-Hodgkin lymphoma, leukaemia, ovary, pancreas, multiple myeloma, uterus body, brain and central nervous system, liver, and kidney) using a new-user active-comparator (direct oral anticoagulants [DOACs]) cohort design.
Methods: We conducted studies using population-based databases from England and Hong Kong (HK). People with atrial fibrillation aged ≥18 years who had first anticoagulant treatment during study period (2011.01.01-2019.12.31) were involved.
Results: Compared with DOAC use, an increased hazard of overall cancer was found in warfarin users (hazard ratio [HR] 1.09, 95% confidence interval [CI] 1.01-1.18) in England; however, no evidence supported such association in HK (HR=0.89, 95%CI=0.79-1.01). For site-specific cancers, increased hazard of colorectal cancer was observed in warfarin users versus DOAC users in England (HR=1.22, 95%CI=1.03-1.46) but not in HK (HR=1.08, 95%CI=0.81-1.44); lower hazard of female breast (HR=0.49, 95%CI=0.30-0.80), ovarian (HR=0.07, 95%CI=0.01-0.58), and pancreatic (HR=0.45, 95%CI=0.22-0.94) cancers and a higher hazard of kidney cancer (HR=3.53, 95%CI=1.62-7.69) were found, comparing warfarin with DOACs in HK, but not in England.
Conclusions: This study does not find protective effect of warfarin against cancer versus DOACs. The risks of site-specific cancers including colorectal, pancreatic, kidney and sex-specific cancers between oral anticoagulants may require further investigation in other independent datasets.

Biography

A Medicine Background Epidemiologist in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, London; with expertise in epidemiological methodologies and medication research with Real-World Data in large healthcare database, in particular, database in the United Kingdom and Hong Kong; research interest including but not limited to Pregnancy, Paediatric, Psychiatric, and Cardiovascular Pharmacoepidemiology.
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Dr Shota Hamada
Director
Institute for Health Economics and Policy

Prescription patterns of oral anticoagulants in older adults with atrial fibrillation

Abstract

Introduction: The prevalence of oral anticoagulants (OACs) in older adults with atrial fibrillation (AF), especially those on long-term care (LTC), is unclear.
Aims: To evaluate the trend of prescriptions of OACs in older adults in Japan.
Methods: This population-based study based on medical and LTC claims data obtained from Hachioji city, Tokyo, included participants aged ≥75 years, with recorded diagnoses of AF, and without recorded diagnoses of valve diseases or venous thromboembolism. Prescriptions of OACs were evaluated between during a 3-month period (from September to November) from 2014 to 2019, overall and by LTC needs (categorized into 4 groups: no LTC needs certification, support levels, care levels 1 and 2, and care levels 3 to 5).
Results: In 2019, among 3,574 participants (mean 83 years and 44% women), one-third (38%) were certified with their LTC needs, including 9% having care levels 3 or higher. The prevalence of OACs from 2014 to 2019 increased from 56% to 71% in overall and 49% to 71% in participants with care levels 3 or higher, respectively. In 2019, the prevalence of OACs (70% to 72%) was similar across different LTC needs. The proportion of participants receiving direct oral anticoagulants (DOACs) in those receiving OACs increased from 42% in 2014 to 84% in 2019, and in 2019 the proportion was not varied by LTC needs (81% to 86%).
Discussion: This study demonstrated that the increased prescriptions of OACs in older adults with AF, including those with high levels of LTC needs, which might be attributed to the increased use of DOACs. The results should be carefully interpreted by the possibility of differences in recording of AF diagnosis by year and LTC needs. Further evidence on benefit and risk assessment of OACs in this vulnerable population is needed for medication optimization.

Biography

Dr. Shota Hamada is the Director of Research Department, Institute for Health Economics and Policy, Japan. His current research focuses on understanding and addressing inappropriate polypharmacy in older adults through primary data collection from long-term care facilities (nursing homes) and secondary data analysis of large-scale datasets (eg, national claims database).
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Dr Nikita Pal
Doctoral Research Scholar
JSS College of Pharmacy, Mysuru

Prescription Patterns of Lipid-lowering Therapies in Patients with Atherosclerotic Cardiovascular Disease (ASCVD)

Abstract

Introduction. Lipid lowering therapy (LLT) is important to treat atherosclerotic cardiovascular disease (ASCVD).
Aims. To evaluate the prescription pattern of LLTs and identify the percentage of patients with ASCVD who have achieved target LDL-cholesterol levels based on various guidelines such as, ESC, ACC/AHA, and LAI guidelines.
Methods. A hospital-based, prospective study was conducted in the OPD of Cardiology from January 2024 to March 2024. Participants with a known history of ASCVD of either gender, aged ≥ 40 years receiving statin therapy, were enrolled in the study. The patients receiving statin therapy with baseline lipid profile records and completed 1 month of follow-up were analyzed.
Results. A total of 108 eligible patients (70% males, 30% females) with a mean age of 61.21±10.1 years were studied. Hypertension (HTN) and type-II diabetes mellitus (T2DM) were prevalent comorbidities (81% and 43%, respectively). The body mass index (BMI) of majority of the study population (57%) ranged from 25.0-29.9 kg/m2 i.e., overweight with an average BMI of 26.6 ± 3.31kg/m2. ASCVD patients’ average baseline LDL-cholesterol levels was ranged 88.81 ± 33.3 mg/dL. Of 666 prescribed medications (average 6.1 per patient), 100% received statins, followed by 44% received Ezetimibe monotherapy or combination therapy, 14% received Bempedoic acid, and 4% received fibrates. On one-month of follow-up patients’ average LDL-C level was 71.7 ± 16.5 mg/dL and non-HDL-C was 84.5 ± 18.3 mg/dL . According to the ACC/AHA and ESC guidelines for very high-risk patients having pre-existing ASCVD, non-HDL-C goal (< 100 mg/dL) was achieved after one month.
Conclusion. There is an utmost need to optimize the prescribing patterns of LTTs to attain the LDL-C goals according to the standard guidelines. Strategies to manage other comorbidities and counselling for lifestyle modification are the need-of-the-hour to minimize the risk of further events and ensure the patient safety.


Biography

Dr. Gangadharappa H.V. is currently working as associate professor in the Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru. He has completed Post graduation in the year 2005 and PhD in 2013. He has published more than 135 articles in reputed national and international journals and two Indian patents. His core research area is graphene nanoribbons and silk-fibroin-based drug delivery systems. He has guided 8 Ph.D. scholars and 65 Post graduate students. He has received research grant with a tune of 32 Lakhs from Indian Council of Medical Research, New Delhi.
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Solaiman Alhawas
Senior Drug Safety Expert
SFDA

Lower Limb Amputation Association with Sodium-Glucose co-Transporter-2 inhibitors: Systematic review and Meta-Analysis

Abstract

Sodium-Glucose-Cotransporter-2 Inhibitors (SGLT-2i) were approved for management of type II Diabetes Mellitus (DM II), heart failure, and chronic kidney disease. In patients with DM II, positive association of Lower Limb Amputation (LLA) among diabetic patients was shown in many meta-analysis studies but were highly sensitive to the exclusion of CANVAS Program studies. In non-diabetic patients, there were few Randomized Controlled Trials (RCTs) that reported LLAs but did not indicate a significant association.

To conduct a comprehensive systematic review and meta-analysis of RCTs to assess association of SGLT-2i and the risk of LLA regardless of the indications.

We performed a systematic search within CENTRAL, PubMed, Embase, and Google scholar databases from inception to April 31st, 2024. RCTs comparing SGLT-2i to placebo or active control were included. The primary outcome was incidence of LLA. Two authors extracted the data independently from each eligible study then crosschecked. Any discrepancies were resolved by consensus. Publication bias was assessed using forest plot. Comprehensive Meta-Analysis software (version 3.0) was used for analysis.

A total of 20 studies reporting LLA were included. Most studies reported a follow-up period of 6 months to 4 years. Due to high heterogeneity (I2>50%), a random effect meta-analysis model was performed. No significant difference in incidence of LLA between SGLT-2i users compared to the control groups regardless of the indication (OR, 1.26 [95% CI, 0.98-1.6]). In addition, the stratification by diabetes status; diabetic (OR, 1.32 [95% CI, 0.99-1.79]) versus non-diabetic (OR, 1.07 [95% CI, 0.77-1.49]) yielded similar results.

No significant difference in the incidence of LLA between SGLT-2i users and non-users was observed. The positive associations shown in previous studies were highly sensitive to the exclusion of CANVAS program studies that lack adjudication committee for LLA assessment. Due to limited studies included, results in non-diabetic patients should be interpreted with caution.

Biography

Solaiman Alhawas, PharmD is a Medication Use Safety and Policy Consultant graduated from college of pharmacy in 2016 and completed specialty residency in Medication Use Safety and Policy in 2020. He is currently a Senior Safety Expert in Saudi Food and Drug Authority working on safety signals evaluation, signal confirmation, drug safety consultations, and periodic benefit-risk evaluation reports assessment. Solaiman has published several abstracts on pharmacovigilance of medications and interested in fields of drug safety/policy and research.
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Miss Caroline Trin
PhD candidate
Monash University

Long-term use of beta-blocker therapy after myocardial infarction

Abstract

Introduction: Beta-blocker (BB) therapy has been considered a cornerstone in cardiovascular disease management for years. Initially renowned for its efficacy in reducing mortality and morbidity post-myocardial infarction, contemporary evidence presents a more contradictory scene. While historical data strongly supported BB therapy's benefits, recent observational studies and randomised controlled trials (RCTs) reveal conflicting results.
Aims: This review aims to summarise and compare the existing evidence from the pre-reperfusion era and modern practice on BB therapy on different health outcomes.
Methods: a State-of-the-Art Review was performed by searching the grey literature for clinical guidelines in US, Europe, and Australia on post-MI management. The most influential randomised clinical trials (RCTs) conducted in the pre-reperfusion era were searched using CENTRAL database (1960-1980) and the current evidence was searched using CDSR, Embase, and Medline (2014 to the present).
Results: Real-world evidence, RCTs, and meta-analyses offer inconsistent conclusions regarding BB therapy's long-term effectiveness, especially in patients with preserved left ventricular ejection fraction (LVEF). Methodological limitations, such as selection bias, and heterogeneity concerning inclusion and exclusion criteria, complicate the interpretation of results. Consequently, contemporary guidelines vary in their recommendations reflecting the uncertainty surrounding BB therapy's role in modern cardiovascular care.
Conclusion: Although BB therapy has been a fundamental part of secondary prevention post-MI for decades, current evidence suggests that its long-term effectiveness in improving health outcomes is inconclusive in patients with preserved LVEF. Additionally, many questions remain unanswered that require further investigation to reach a consensus on BB therapy’s effectiveness post-MI. The possibility of discontinuing BB use in patients where there is no clear benefit could reduce polypharmacy, improve medication adherence, and lower the overall burden on patients and the healthcare system. This may simplify treatment regimens, minimise side effects, and decrease healthcare costs associated with unnecessary medications.

Biography

I completed my undergraduate degree in Biomedical Science at Monash University in 2021. Following this, I pursued a Master’s in Public Health with a specialization in Epidemiology, graduating in 2024. During my master's, I undertook a placement focusing on real-world evidence, pharmacoepidemiology, and exploring the association of polypharmacy with liver and kidney function. Currently, I am pursuing a PhD in Pharmacoepidemiology, where my research is centred on identifying risk factors associated with medication non-adherence in individuals on lipid-lowering therapy.
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Dr Nikita Pal
Doctoral Research Scholar
JSS College of Pharmacy, Mysuru

Knowledge, Attitude & Practice of Patients Toward Cardiovascular Disorders Attending the Out-Patient Department of Cardiology

Abstract

Aims. To assess the level of knowledge, attitude, and practice (KAP) of patients toward cardiovascular diseases (CVDs) attending the Out-patient Department (OPD) of Cardiology during the study period.
Methods. A hospital-based, cross-sectional study was carried out at the OPD of Cardiology for 4-weeks. A 36-item questionnaire about the risk factors and preventive strategies of CVDs was developed, validated (Cronbach’s alpha for reliability test is 0.87), and generated for participants aged ≥ 18 years. Chi-square test was used to compare categorical data and Multinomial logistic regression was used to identify the factors influencing knowledge, attitude, and practice level.
Results. A total of 112 patients [75% males, 25% females] with a mean age of 58.96 ± 13.38 years participated in the study. Out of them, 71% came from rural areas, and 40% belonged to the lower middle class of socio-economic status. The majority [102 (91%)] of the participants were diagnosed with ischemic heart disease (IHD). All three KAP scores were of poor to excellent levels. The overall knowledge score was poor [78.57%], attitude and practice scores were excellent [82.14%], and [83.93%], respectively. The CVD knowledge, attitude, and practice mean scores amongst CVD patients were 9.79 ± 5.28, 4.38 ± 1.64, and 7.12 ± 1.80, respectively. There was a significant association found between marital status and knowledge level , socioeconomic status and attitude level, and age and practice level. In Multinomial logistic regression analysis, male gender (p = 0.019) and unmarried (p = 0.000) participants were significantly associated with high attitude scores.
Conclusion. The attitude and practice level amongst the participants were adequate, but the knowledge level was poor. Therefore, there is a necessity to target specific populations with tailored health education programs regarding lifestyle modification, and reduction of risk factors associated with CVDs to ameliorate the level of knowledge.

Abstract Document

Biography

Dr. Nikita Pal is a Doctoral Research Scholar working in the "Evaluation of Impact of Digital Health Technologies in Cardiovascular Diseases" at the Department of Cardiology in JSS Hospital, Mysuru, Karnataka, India. Hailing from the North-eastern part of India and with limited exposure in Pharmacoepidemiology, she aspires to work on the patient-specific guideline-directed tailored therapy amongst patients with cardiovascular diseases, especially in developing country scenario. She is learning to fulfill her passion for advancing knowledge in the domain of rational drug use and she is keen to present her humble work through this international conference to meet the art and science of Pharmacoepidemiology itself.
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Dr. Aarohi Vashi
Resident
JSS College of Pharmacy, Mysuru

Identification of Drug-related Problems Associated with Stroke Management: A Hospital- based Observational Study

Abstract

Aims. The study aimed to identify the drug-related problems (DRPs) in patients diagnosed with stroke.
Methods. A single-center, hospital-based, prospective, observational study was carried out in the Departments of
Mahavir Trauma Hospital for 6 months. Patients aged above 18 years, irrespective of any gender and diagnosed with
both hemorrhagic & ischemic stroke were enrolled in the study. We followed them up till discharge.
Results. A total of 105 patients [78(74.28%)], males; 27(25.71%), females] were studied. The study population aged
41-70 years [53(50.47%)] were highly prevalent of stroke. The majority of the patients were diagnosed with ischemic
stroke [66(62.85%)], followed by diagnosed with hemorrhagic stroke [39(37.14%)]. Of them, [14(13.33%)] patients had
a history of stroke. Among them, 16 patients were measured with homocysteine level where [4(25%)] patients had a
high level of homocysteine. A total of 91 different medications were used amongst patients, where most commonly
prescribed medications include Levetiracetam [63(60.00%)], Cephalosporins [57(54.52%)], Aspirin [46(43.80%)],
Enoxaparin [45(42.85%)], Labetalol [24(22.85%)] and Mannitol [37(35.23%)]. A total of 80 DRPs were found in patients
which includes omission of therapeutic monitoring [18(17.14%)], followed by, administration error [16(15.23%)], drug-
drug interactions [15(14.28%)], dispensing error [12(11.42%)], prescription error [10(9.52%)], adverse drug reactions
[7(6.66%)], drug-food interactions [1(0.95%)] and omission error [1(0.95%)]. The most commonly observed ADRs were
Mannitol induced hypotension and dry mouth. The survival rate of study participants was 72%.
Conclusion. This study helped to identify the rate and patterns of DRPs affecting the clinical outcomes of patients
diagnosed with different clinical sub-types of strokes. It is believed that early detection of DRPs may improve the
therapeutic outcome and survival rate of the stroke patients.

Abstract Document

Biography

Dr.Aarohi Vashi is a Resident of Pharmacy Practice at JSS College of Pharmacy. She is an active, highly motivated & enthusiastic student. She has done her research in field of Pharmacoepidemiology and served for patient safety outcomes and since then her interest in field has been high. She is a quick learner & wants to uplift herself in this field.
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Dr Nikita Pal
Doctoral Research Scholar
JSS College of Pharmacy, Mysuru

Evaluation of Clinical Characteristics and 90-day Outcomes amongst Heart Failure Patients: Insights from a Tertiary-care Hospital Settings

Abstract

Introduction. Heart Failure (HF) is a chronic, multi-faceted, life-threatening condition that has become a major global public health concern.
Aims. To assess clinical characteristics, prescribing patterns, and 90-day clinical outcomes of patients with HF.
Methods. A six-month prospective cohort study was carried out with HF patients aged ≥ 18, of any sex, in New York Heart Association (NYHA ) Class I-III with LVEF ≤ 40% to > 50%, at a tertiary-care hospital's Cardiology department. After consenting, their complaints, past medications, and current treatments were recorded. Data were analysed using frequencies, percentages, and linear regression to identify outcome predictors.
Results. A total of 84 patients (75% male, 25% female, mean age 60.08 ± 10.11 years), 94% had heart failure with reduced ejection fraction (HFrEF), with 44% de-novo, and 48% in NYHA class III were enrolled in the study. Hypertension (HTN) and type 2 diabetes mellitus (T2DM) were prevalent comorbidities (67% and 54%, respectively). 35% were hospitalized for ischemic heart disease (IHD) and 12% for dilated cardiomyopathy (DCM). Of 685 prescribed medications (average 8.2 per patient, mean 10.54), only 37% were guideline-directed medical therapy (GDMT), with β-Blockers (89%), sodium-glucose cotransporter-2 (SGLT2) inhibitors (68%), angiotensin receptor-neprilysin inhibitors (ARNI) (67%), and mineralocorticoid receptor antagonists (MRA) (50%) most prescribed. The 90-day mortality was 2%, with a 10% readmission rate for acute decompensated heart failure (ADHF) and an average hospital stay of 4.46 ± 1.60 days. Ischemic heart disease emerged as a significant predictor for 90-day outcomes (β = 0.503 [0.113-0.573], p = 0.004).
Conclusion. IHD is one of the predictors implicating heart failure in the study cohort. The 90-day mortality was two in every ten patients and the majority of the management did not comply with GDMT, which demands drug therapy optimization in anticipation of improved clinical outcomes.
Keywords: Heart failure, Ischemic heart disease, Guideline-directed medical therapy, Acute decompensated heart failure.

Abstract Document

Biography

Dr. Nikita Pal is a Doctoral Research Scholar, working in the "Evaluation of impact of digital health technologies in cardiovascular diseases" at the Department of Cardiology in JSS Hospital, Mysuru, Karnataka, India. Hailing from the North-eastern part of India and with limited exposure in Pharmacoepidemiology, she aspires to work on the patient-specific guideline-directed tailored therapy amongst patients with cardiovascular diseases, especially in developing country scenario. She is learning to fulfill her passion for advancing knowledge in the domain of rational drug use and she is keen to present her humble work through this international conference to meet the art and science of Pharmacoepidemiology itself.
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Miss Xuan Yin
China Pharmaceutical University

Epidemiology, characteristics, and prognosis of heart failure with partial improved ejection fraction

Abstract

Introduction:

A subset of patients diagnosed with heart failure (HF) with reduced ejection fraction (HFrEF) demonstrate partial improvement in left ventricular ejection fraction (LVEF). However, there is limited information on the epidemiology, clinical characteristics, and prognosis for these patients with HF exhibiting partially improved ejection fraction (HFpimpEF). Understanding these aspects is crucial for optimizing patient management and outcomes.
Aims:

The main objective of this study was to comprehensively assess the epidemiological aspects, clinical features, and prognosis of patients with HFpimpEF.
Methods:

Among 3,691 adults with HF who had two LVEF echocardiograms at least three months apart in Yinzhou District, 350 were initially categorized as HFrEF (LVEF ≤40%). These were further classified into subtypes: persistent HFrEF (pHFrEF) (LVEF ≤40%), HFpimpEF (LVEF 41-49%, improvement <10%), and HF with improved ejection fraction (HFimpEF) (LVEF >40%, improvement ≥10%). The primary outcome was all-cause death or first HF-related readmission.
Results:

During a median follow-up of 15.6 months, 62 (17.7%) patients were classified as HFpimpEF. Using multivariable Cox models, HFpimpEF demonstrated a lower risk of readmission or death compared to pHFrEF after adjustments (adjusted hazard ratio: 0.55; 95% CI, 0.31-0.96; P=0.037).
Discussion:

Given its unique clinical presentation, HFpimpEF should be recognized as a distinct HF subtype. This subtype is characterized by partial improvement in LVEF and generally has a more favorable prognosis compared to pHFrEF. These findings underscore the importance of identifying and managing HFpimpEF as a separate entity to improve patient outcomes.

Biography

Xuan Yin is a post-graduate student in China Pharmaceutical University, majoring in public administration. Her research areas include clinical epidemiology, pharmacoepidemiology, heart failure, cardiovascular disease, cardiac oncology, anesthesia and hemodynamics.
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Dr Nikita Pal
Doctoral Research Scholar
JSS College of Pharmacy, Mysuru

Discrepancies between Prescribed and Defined Daily Doses of Four-Pillar Therapy in Congestive Heart Failure Patients

Abstract Document

Biography

Dr. Nikita Pal is a Doctoral Research Scholar working in the "Evaluation of Impact of Digital Health Technologies in Cardiovascular Diseases" at the Department of Cardiology in JSS Hospital, Mysuru, Karnataka, India. Hailing from the North-eastern part of India and with limited exposure in Pharmacoepidemiology, she aspires to work on the patient-specific guideline-directed tailored therapy amongst patients with cardiovascular diseases, especially in developing country scenario. She is learning to fulfill her passion for advancing knowledge in the domain of rational drug use and she is keen to present her humble work through this international conference to meet the art and science of Pharmacoepidemiology itself.
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Yen Hsun Chen
National Cheng Kung University, Tainan, Taiwan

Different potency of statin on major adverse cardiovascular events among Taiwanese patients

Abstract

-Introduction Statin treatment has proved to be cardioprotective (e.g., lowering incidence of major adverse cardiovascular events [MACE]) compared with non-treatment. However, few evidence regarding the effectiveness of different potency of statin on MACE exist, with inconsistent findings among patients with atherosclerotic cardiovascular disease patients (ASCVD) reported.
-Aims This retrospective cohort study aimed to evaluate comparative effectiveness of high/moderate- versus low-potency of statin on preventing MACE in patients with ASCVD.
-Methods 14,748 ASCVD patients with any statin prescriptions from 2014 to 2017 were identified from the electronic health records of National Cheng Kung University Hospital in Taiwan. Statin users were categorized into high/medium-potency or low-potency groups, with a 3: 1 propensity-score matching applied for these two groups in order to ensure between-group comparability at baseline. Study outcomes included MACE and individual components (i.e., ischemic stroke, non-fatal myocardial infarction [MI]). Cox proportional hazard model analyses were performed to assess the cardiovascular risk (e.g., MACE) with statin exposure (i.e., high/medium- vs. low-potency). All analyses were separated for incident new and stable (i.e., having at least chronic prescription refill or two consecutive prescriptions with a gap<7 days) statin users.
-Results Compared with low-potency statin, the use of high/medium-potency statin was associated with insignificantly increased MACE risk (i.e., hazard ratio [HR], 95% confidence interval [CI]: 1.53 [0.86-2.75]) among statin new users, but not stable users (0.97 [0.64-1.48]). Moreover, the stable use of high/medium statin was associated with an insignificantly decreased stroke risk (0.640 [0.36-1.15]) but increased risk in new users (1.28 [0.63-2.58]). A trend of increased MI risk with use of high/medium- versus low-potency statin was observed in both new and stable users (2.35 [0.89-6.26], 1.46 [0.81-2.64]).
-Discussion/Conclusion Different potency of statin might not affect the risk of development of MACE. Future large-scale studies from other countries or races/ethnicities are warranted to corroborate our findings.

Biography

I graduated from the Department of Pharmacy at National Cheng Kung University in Taiwan this summer. During my time at school, I held the position of design officer in the NCKU Pharmacy Student Association and also worked as a lecturer for a pharmacy course at NCKU Medical Camp. In terms of research experience, I participated in the 2020 NCKU College of Medical Summer Student Program and was awarded the Undergraduate Research Fellowship by the Ministry of Science and Technology (MOST) in Taiwan in 2023.
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Tung-Chun Chien
Graduate Institute of Clinical Pharmacy, National Taiwan University1, Taipei, Taiwan

Combination therapy with sacubitril/valsartan and SGLT2 inhibitors for HFrEF with renal dysfunction

Abstract

Introduction: Previous trials have highlighted the renal benefits and overall effectiveness of sacubitril/valsartan (S/V) and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD). However, concerns have been raised about the limited applicability of these findings in clinical practice due to the relatively small number of CKD patients included in previous studies. Furthermore, there is a lack of research investigating the combined use in HFrEF patients with an eGFR below 30 mL/min/1.73 m².
Aims: We attempted to develop a model which allows us to investigate the feasibility of the optimal combination therapy across the spectrum of time-varying eGFR, specifically levels below 30 mL/min/1.73 m², and to identify the strengths of—and barriers in putting into practice—the combination therapy with S/V and SGLT2i, among real-world patients with HFrEF and CKD.
Methods: We developed a time-varying prediction model based on data retrospectively extracted from electronic health records at the National Taiwan University Hospital, with interaction terms where eGFR levels were stratified with S/V and SGLT2i. The cohort comprised 501 patients initially prescribed S/V between March 2017 and January 2020. We identified critical predictors within the time-dependent Cox regression framework using a stepwise variable selection procedure with a penalized smoothing spline method.
Results: The model—which identified 43 critical predictors—revealed that such usage was associated with enhanced survival rates in patients with HFrEF, particularly those with an eGFR below 30 mL/min/1.73 m². Maintaining a cumulative daily dosage of 180-mg S/V with SGLT2i treatment for at least three months was associated with reduced mortality. Notably, this observed benefit did not seem to be counteracted by a decline in eGFR.
Conclusion: The combination therapy using S/V and SGLT2i demonstrates promising potential in improving survival outcomes among patients with HFrEF, particularly those with compromised renal function.

Biography

Tung-Chun Chien is a graduate student specializing in clinical pharmacy. He earned his bachelor's degree from the Department of Pharmacy at National Taiwan University (NTU), where he also pursued double majors in Foreign Languages and Literatures, and Philosophy, before embarking on his pharmacy journey. His research primarily focuses on liberal arts-oriented topics such as patient education, supplemented by a foundational understanding of computer science acquired through additional coursework during his undergraduate studies. Leveraging digital technology, his research aims to enhance patient education, fostering active engagement and informed decision-making in treatment processes. The culmination of this work, which he will soon present, involves the integration into a dashboard tool designed to accurately assess patients' risk. This tool will visualize evidence-based information on the screen in an easy-to-understand manner, facilitating patient engagement within the pharmacist-led heart failure clinic at NTU Hospital in the future and streamlining translation from bench to bedside.
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Associate Professor Dr. Dujrudee Chinwong
Associate Professor
Chiang Mai University

Cognitive Impairment Among Patients with Cardiovascular Diseases: Comparisons of Sex, Elderly, Education

Abstract

Introduction/Aims: Evidence showed the relationship between cognitive impairment and cardiovascular diseases (CVD), but few studies used the Montreal Cognitive Assessment (MoCA) to assess cognitive impairment. MoCA was validated and designed to detect mild impairment with higher sensitivity. This study aimed to determine the cognitive impairment and compare between sex, the elderly, and education level.
Methods: This cross-sectional study was conducted among patients with CVD at a teaching hospital in northern Thailand. Cognitive impairment was evaluated by interviewing patients using the MoCA as a tool, with MoCA score <25/30 classified as cognitive impairment.
Results: Of 113 patients (52% male, mean age of 63±14.9 years), the prevalence of impaired cognitive function among patients with CVD was 78.8%, 95% confidence interval (95% CI): 70.06-85.89. The prevalence did not differ by sex but differed by age and education. Older patients were more likely to have cognitive impairment than younger ones (≥65 years, 87.3% vs. <65 years, 70.7%; OR, 2.84 (95% CI: 1.07-7.53). Patients with low education were higher in cognitive impairment (primary school or lower, 86.2% vs. higher than primary school, 58.8 %; OR, 4.36 (95% CI: 1.63-11.61).
Discussion/Conclusion: Four-fifths of CVD patients had cognitive impairment, which was not sex-dependent but age and education-dependent. Our findings suggest the need for routine cognitive screening in patients with CVD.

Biography

My name is Dujrudee Chinwong, an Associate Professor at the Faculty of Pharmacy, Chiang Mai University, Thailand. I graduated with a PhD (Clinical Epidemiology) from the Chiang Mai University, Thailand in 2016. I completed my PhD in Clinical Epidemiology at Chiang Mai University in 2016. In addition to educating both undergraduate and postgraduate students, my research has been centered on clinical epidemiology, with a particular emphasis on geriatric, cardiovascular disease, health outcome research, tobacco control and e-cigarettes.
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Dr Cheng-Yen Lu
Da-Yeh University

Blood pressure variability and risk of cardiovascular events in real-world clinical settings

Abstract

Introduction: Clinical trials and cohort studies reveal that elevated visit-to-visit variability in blood pressure (BP) is associated with an increased risk of cardiovascular events and poor outcomes. However, the real-world applicability of long-term BP variability measurements remains underexplored.
Aims: To evaluate the association of visit-to-visit BP variability collected from regular outpatient settings with the risk of cardiovascular events and all-cause mortality in an unselected patient population.
Methods: In this retrospective cohort study at a large academic medical center in Taiwan, we calculated variability independent of the mean (VIM) and average real variability (ARV) of BP using electronic health records of 16,945 adults with at least one outpatient BP measurement in three consecutive years from 2012 to 2017. The association of BP variability with the risk of cardiovascular events and all-cause mortality through 2020 was assessed using Cox proportional hazard models.
Results: Over a median follow-up of 4 years, 317 patients experienced cardiovascular events, and 582 died. The adjusted hazard ratios (HRs) for cardiovascular events increased gradually across both VIM and ARV quartiles of BP. The adjusted HRs (95% CIs) per interquartile range increase in systolic BP variability were 1.24 (1.09-1.41) for VIM and 1.11 (1.01-1.23) for ARV. For diastolic BP, the HRs (95% CIs) were 1.22 (1.09-1.36) and 1.13 (1.02-1.24), respectively. Similar results were observed for all-cause mortality, except a weaker association with ARV of diastolic BP (HR: 1.08, 95% CI: 0.99-1.17). The association between VIM of BP and risk of cardiovascular events was consistent across patient subgroups, even in those with BP levels currently considered to be the normal range.
Discussion: Our findings support the practicality of incorporating BP variability measures, which is readily available from regular outpatient settings, into real-world practice. Further investigations are needed on how antihypertensive treatments affect BP variability and cardiovascular outcomes.

Biography

Chung-Yen Lu, MD, PhD, is the superintendent of the Long Health Chinese Medicine Clinic and an adjunct professor in the Department of Sport and Health Management at Da-Yeh University in Taiwan. He received his PhD in Public Health from National Taiwan University and his MD from the School of Post-Baccalaureate Chinese Medicine at China Medical University in Taiwan. Dr. Lu’s earlier work focused on environmental epidemiology, specifically examining the health effects associated with indoor air pollutants. Leveraging his dual training in epidemiology and traditional Chinese medicine, his current work centers on epidemiology and outcomes of cardiovascular and cerebrovascular diseases, particularly focusing on the patterns of traditional Chinese medicine care and the associated treatment outcomes.
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Alfi Yasmina
Faculty of Medicine & Health Sciences, Universitas Lambung Mangkurat

Association between antihypertensive types and hospital stay and mortality in stroke patients

Abstract

Introduction: Hypertension is one of the risk factors for stroke, and antihypertensive agents are administered to improve outcomes in ischemic stroke patients. Appropriate use of antihypertensive types in ischemic stroke may influence stroke morbidity and mortality.
Aim: This study aimed to determine the association between the type of antihypertensive agents and the length of hospital stay and mortality in ischemic stroke patients.
Methods: The research method employed was retrospective cohort, conducted on ischemic stroke patients treated in a public hospital in Banjarmasin, South Kalimantan, Indonesia, who received antihypertensive therapy during 2018-2021. The independent variable was the type of antihypertensives, while the dependent variables were the length of hospital stay and mortality. Age, gender, education level, and comorbidities were considered as confounding variables. The association between independent variables and the length of hospital stay was analyzed using linear regression, while logistic regression was used to analyze their relationship with mortality.
Results: The study included 175 subjects, predominantly aged 18-64 years (64.6%), male (54.3%), and with low education level (41.7%). The type of antihypertensives used were combination antihypertensives (40.6%), CCBs (21.7%), ACEIs (6.9%), ARBs (25.7%), and beta-blockers or diuretics (5.1%). Administration of beta-blockers or diuretics significantly increased the risk of mortality (RR 6.30, 95% CI 1.40-28.42, p = 0.02). Higher education (regression coefficient -3.83, 95% CI 7.102-(-0.565)) and comorbidities (-3.30, 95% CI 6.59-(- 0.01)) influenced the association between the type of antihypertensives and the length of hospital stay. \
Conclusion: The type of antihypertensives is associated with mortality in ischemic stroke patients, and higher education level and comorbidities affect the association between the type of antihypertensives and the length of hospital stay in ischemic stroke patients.

Biography

I am a lecturer on pharmacology in Faculty of Medicine and Health Sciences, Universitas Lambung Mangkurat.
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Raghava Kalyan Maddukuri
Assistant Professor
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences

Aspirin for Prophylaxis of VTE: Systematic Review and Meta-analysis of Non-Randomized Studies

Abstract

Objective: Aspirin as an agent for thrombo-prophylaxis in patients with Total Hip Replacement (TKR)& Total Knee Replacement (THR) is gaining a lot of importance in preventing Venous Thrombo-embolism (VTE) complications. Current guidelines don’t recommend aspirin over other anti-coagulants as the data from the meta-analysis of RCT’s lacked a significant sample to draw conclusive results. The present study was aimed to carry out a systematic review and meta-analysis of non-randomized studies (NRS) to determine the effect of aspirin as prophylaxis for VTE.
Methods: A complete electronic search was conducted at PubMed, Cochrane central controlled trial register (CENTRAL), and Google Scholar for relevant articles published till March 2022. All the non-randomized, observational studies that compared the efficacy and safety outcomes pertaining to prevention of VTE between aspirin and other anti-coagulants among THR and/or TKR patients were included in the analysis. Any post-surgical VTE event (DVT and/or PE) is considered the primary outcome and adverse events as secondary outcomes. Both efficacy and safety outcomes were reported as pooled risk estimates with 95% CI with a level of significance at P < 0.05. A total of 21 studies were identified for the analysis.
Results: The overall risk of occurrence of VTE among the patients taking aspirin was not significantly different from anticoagulants (RR, 0.78, 95% CI, 0.52-1.15). Patients who underwent THR had a higher risk for VTE with aspirin (RR, 1.50, CI 95%, 1.35-1.61), while the patients who underwent TKR showed a lower risk of VTE with Aspirin (RR 0.80, CI 95%, 0.75-0.85).
Conclusion: Meta-analysis of NRS advocates the role of Aspirin as a prophylactic agent for VTE, especially for patients who are in need for TKR. Further RCT’s are required to re-establish the role of aspirin especially in patients undergoing THR.

Key words: Aspirin, Anti-coagulants, VTE prophylaxis, THR/TKR

Biography

Currently working as Assistant professor in the department of Pharmacy Practice, I am a Pharmaco-epidemiology enthusiast. Automated and Hospital and databases as a source of data for pharmacoepidemiology is something that i am willing to explore in the near days. Pharmaco-epidemiologic methods are my strength and i willing to apply all these methods with vast sources of data that are available in all these databases.
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Dr. Mohammad Bakhriansyah
Senior Lecturer
Faculty of Medicine and Health Sciences, Universitas Lambung Mangkurat

Interaction of Disease Modifying Anti Rhematoid Drugs in A Public District Hospital

Abstract

Introduction. Drug-drug interactions (DDIs) due to polypharmacy can lead to detrimental conditions that might interfere therapeutic goals, and increase morbidity and mortality rates and health care costs. Rheumatoid arthritis (RA) is a joint disorder often found as a result of disruption of immune function and patients with it are often prescribed polypharmacy.
Aims. This study aimed to determine the association of potential adverse DDIs between the use of Disease Modifying Anti Rheumatoid Drugs (DMARDs) in RA patients with polypharmacy compared to those without polypharmacy.
Methods. This cross-sectional study was conducted at a District Public Hospital Banjarmasin using data from 2022-2023. Data of potential adverse DDI were inputed into Lexicomp® application and then analyzed by using binomial logistic regression test.
Results. This study showed that 815 drug-drug interactions were found in 95 patients. All prescribed DMARDs were conventional synthetic (n=569). Most of dug interaction was under category D (i.e therapy is considered to modify) by 365 drug pairs (44.79%). A combination of methotrexate and folic acid was most frequently prescibed by 207 times (25.40%) and under category A (no interaction was found) followed by a combination of leflunomide and methylprednisolon by 187 times (22.94%). The later drug might increase immunosupresant effect of leflunomide. Meanwhile, according to the level of severity most of DDIs was moderate by 534 drug pairs (65.52%). 365 (45.34%) of them were potentially harmful, but 450 (54.66%) were not. Polypharmacy was found for 759 (94.29%) drug pairs, while 56 (5.71%) were not. RA patients precribed DMARDs with polypharmacy did not have a significant different event of DDIs compared to those who were not prescribed polypharmacy (crude POR 0.634, 95%CI, 0.367-1.094, p=0.102).
Conclusion. This study demonstrates that there is no significant difference in potential adverse DDIs between DMARDs polypharmacy compared to non-polypharmacy in patients with RA.

Biography

dr. Mohammad Bakhriansyah, M.Kes., M.Med.Ed., M.Sc., Ph.D is a senior lecturer in pharmacoepidemiology in Faculty of Medicine and Health Sciences, Universitas Lambung Mangkurat, Banjarmasin Indonesia since 1999. He graduated from 3 different universities for his master degrees, i.e. in pharmacology, medical education and epidemiology from Universitas Gadjah Mada Indonesia, University of Sydney Australia, and Utrecht University The Netherlands, respectively. In 2019, he then completed his doctoral program in pharmacoepidemiology from Utrecht Institute Pharmaceutical Sciences, Utrecht University, the Netherlands. His research interest is both the efficacy and the adverse events including the interaction of the use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
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Qiwen Fang
The University of Hong Kong

Forecasting the incidence and prevalence of inflammatory bowel disease in three countries

Abstract

Introduction
The global exacerbation of inflammatory bowel disease (IBD) has increased the disease burden and economic impact. Gaps remain in understanding the IBD burden in Asian and Western populations.

Aims
To estimate and compare the current and forecasted 10-year incidence and prevalence of IBD in the US, Japan, and Hong Kong.

Methods
Patients diagnosed with IBD were identified from two large employment-based healthcare claims databases in the US and Japan (2010-2022), and a population-wide electronic medical records database in Hong Kong (2003-2022). We used Autoregressive Integrated Moving Average models to predict incidence and prevalence from 2023 to 2032, stratified by age, sex, and disease subtype, with 95% prediction intervals (PI). The forecasted annual average percentage change (AAPC) with 95% confidence intervals was calculated.

Results
In 2022, the IBD incidence per 100,000 was highest in the US (39.62) compared to Japan (26.48) and Hong Kong (4.68). By 2032, the gap between the US (41.86 [95%PI: 35.65, 48.08] per 100,000) and Japan (39.03) is forecasted to narrow, while remaining substantial with Hong Kong (6.19). The fastest forecasted increase in incidence is among those under 18 in Japan (AAPC: 9.06) and the US (AAPC: 4.43), and among adults aged 18-44 in Hong Kong (AAPC: 5.78). The forecasted 2032 incidence per 100,000 in Japan (male: 44.61, female: 33.07) and Hong Kong (male: 8.90, female: 4.19) is higher for males, with the opposite in the US (male: 40.60, female: 42.96). The forecasted incidence of Ulcerative Colitis in Japan (33.28) will surpass the US (23.57) and far exceed Hong Kong (3.17) by 2032; the incidence of Crohn's Disease is expected to be highest in the US (18.31).

Discussion
The projected burden of IBD is increasing in three countries, displaying distinct patterns across age groups, sex, and disease subtypes. Targeted prevention and treatment measures are essential.

Biography

Qiwen Fang has experience in epidemiology and biostatistics. She completed her undergraduate studies at the School of Public Health, Shandong University, between 2016 and 2021, where she honed her skills in data analysis and wet lab techniques. Her undergraduate thesis focused on the association between metal exposure and type 2 diabetes, utilizing logistic regression analysis of the NHANES database. In pursuit of further knowledge, Qiwen continued her academic journey, obtaining a Master's degree from the School of Public Health at the University of Hong Kong between 2021 and 2022. During this period, she gained valuable expertise in epidemiological study design and advanced statistical practices. Building upon her previous research, Qiwen conducted a meta-analysis on the relationship between specific metals and type 2 diabetes for her Master's thesis. In the meanwhile, she contributed as a student research assistant at the School of Public Health, working on a systematic review of non-pharmaceutical strategies for COVID-19 control. Since 2023, Qiwen has been serving as a research assistant in the Department of Pharmacology and Pharmacy at the University of Hong Kong. In this role, she is actively involved in identifying innovative medicines for various therapeutic areas. Her most recent publication, "Efficacy and safety of psilocybin on treatment-resistant depression: A systematic review and meta-analysis," appeared in May 2024, demonstrating the potential of psilocybin as a treatment for treatment-resistant depression. Qiwen Fang's primary research interest lies in pharmaco-epidemiology, with a focus on comparing and analyzing the efficacy, safety, and health resource utilization of different treatment strategies. Through her research, she aims to provide valuable evidence to inform and optimize treatment selection in clinical practice.
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Xintong He
IQVIA

Efficacy of telitacicept in the treatment of SLE: a network meta-analysis

Abstract

Introduction:
Telitacicept is developed and marketed in China for systemic lupus erythematosus (SLE), under clinical trials in the US and EU. Evidence on telitacicept efficacy is limited, especially connected with other biologics.
Aims:
To conduct a network meta-analysis, from randomized controlled trials (RCTs) and observational cohort studies, considering studies both in English and Chinese.
Methods:
We searched PubMed and China National Knowledge Infrastructure (CNKI) (updated to April 2024) and selected studies for biologics measuring SLE response index (SRI)-4, at least 24 weeks. Both the initial search and the study selection were performed by 2 researchers.
For study quality, we used Jadad scale for RCTs and Newcastle-Ottawa scale for observational studies. Publication bias was assessed by funnel plot and Egger’s test. Pooled ORs of response were calculated by random-effect models. Ranking was assessed by Surface Under the Cumulative Ranking Curve (SUCRA).
Results:
Eighteen studies were included (16 RCTs; 2 telitacicept studies; 16 in English) for 10,837 patients. Two studies had high risk of bias, mainly from lack of blinding. No significant publication bias was suggested (Egger’s test p=0.25).
Telitacicept and belimumab ranked the highest (SUCRA: 0.96 and 0.70) for SRI-4 response, followed by atacicept, ustekinumab, sifalimumab, anifrolumab, and rontalizumab (<0.70). Telitacicept (OR 2.16 [1.80, 2.58]), belimumab (1.42 [1.17, 1.71]), atacicept (1.27 [1.08, 1.50]), and sifalimumab (1.28 [1.02, 1.61]) showed significant response versus placebo.
When restricted to studies measuring SRI-4 at 52 weeks (11 studies), the ranking was similar.
Conclusion:
Telitacicept is effective in the treatment of SLE, as proven in direct comparisons but also in this network analysis combining multiple treatment options. It ranked higher than other biologics in terms of SRI-4. This is meaningful given the high prevalence of SLE in China and its association with morbidity and mortality.
Keywords:
Telitacicept, systemic lupus erythematosus, network meta-analysis, efficacy

Biography

Xintong He is a pharmacoepidemiologist and works as a Lead Epidemiologist at Real-World Solutions, IQVIA. Xintong acts as scientific oversight and leads real-world studies, and is experienced in study design and conduction. She holds a master's degree in Epidemiology from Johns Hopkins Bloomberg School of Public Health with some PhD-level training. Xintong is especially experienced in designing and conducting prospective studies, retrospective studies, ambi-directional studies, and synthesized evidence studies, for post-marketing drug effectiveness, safety, patient reported outcomes, and treatment patterns. Working from China for IQVIA Global Epidemiology team, Xintong is responsible for studies in different regions, including APAC, EU, and the US, as well as multi-country studies and multi-continent studies.
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YEN-HAO LIAO
Clinical Pharmacist
Linkou Chang Gung Memorial Hospital

Belimumab utilization evaluation at a tertiary hospital in Taiwan

Abstract

Introduction:
Belimumab is a B-lymphocyte stimulator-specific inhibitor indicated for adult systemic lupus erythematosus (SLE) or lupus nephritis who are receiving standard therapy of glucocorticoids. It was covered by National Health Insurance (NHI) since the end of 2022 in Taiwan. Individuals under belimumab treatment should be assessed for effectiveness to receive payouts from NHI.

Aims:
To determine if current utilization of belimumab was concordant with clinical guidelines and evaluate the effectiveness and safety.

Methods:
We conducted a single-center, retrospective chart review medication utilization evaluation (MUE). Patients initiating belimumab as an add-on therapy to glucocorticoids from August 5, 2023 to March 31, 2024 were included. Data collection contained patients’ basic information, diagnosis, prescription and adverse events related to belimumab. We analyzed the performance of systemic lupus erythematosus disease activity index (SLEDAI), steroid-sparing activity, and adverse reactions, which presented by descriptive statistics.

Results:
Eight patients were included with diagnosis of lupus nephritis from type III to type V. The mean age was 48 years old and 87.5% were female. All patients received 10 mg/kg of belimumab with recommended dosing interval. 50% had SLEDAI reduction at week 15-30, including one achieved disease remission (SLEDAI=0). Those without SLEDAI improvement had shorter follow-up time, ranging from 8 to 12 weeks. No one had change in renal function during the follow-up period. 62.5% had more than 50 % reduction in steroid dose at week 12-36. Among total 51 injections in all patients, four adverse events (infusion-related reaction and edema) occurred in four individuals.

Discussion:
Utilization of belimumab in clinical practice was concordant with guidelines in this evaluation. Belimumab treatment yielded improved outcomes in SLE management and steroids reduction without major adverse events leading to therapy interruption. All patients met NHI payment guidelines during the follow-up period. Long-term evaluation was suggested to increase sample size and complete regimen.

Biography

YEN-HAO, LIAO is a clinical pharmacist of Linkou Chang Gung Memorial Hospital. His work focuses specifically on the clinical pharmacy and pharmacotherapy.
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Dr Dima M Qato
Associate Professor
University of Southern California

Trends in Use of Asthma Inhalers with High Global Warming Potential

Abstract

Introduction: In response to the Montreal Protocol and US Clean Air Act, the FDA banned the production and sale of CFC (chlorofluorocarbon) propelled metered-dose inhalers (MDIs) for asthma in the U.S. Manufacturers largely replaced these MD inhalers with hydrofluoroalkane (HFA) propellants or dry powder inhalers (DPIs). HFA inhalers, however, have high global warning potential and DPIs lack this risk. Despite ongoing global efforts to address climate change in the pharmaceutical supply chain, information on the use of asthma HFA and DPI inhalers in the U.S. is not known.

Aims: To examine trends in the use of asthma HFA and DPI inhalers in the U.S.

Methods: We used IQVIAs National Prescription Audit which captures information on all prescriptions filled at retail pharmacies between January 2018 and December 2023 in the U.S. We analyze the total number of fills per month (monthly fill rates) for all HFA and DPI inhalers overall and separately. We also report changes in the market share for HFA products and the number of new HFA (vs. DPI) generic and branded products.

Results: Between January 2018 and December 2023, the total number of monthly prescriptions dispensed at US pharmacies for asthma inhalers increased from 8.7 million fills/month to 10.4 million fills/month (p<0.001). This increase was largely due to the growth in the volume (from 6.6 million fills/month to 8.4 million fills/month; p<0.001) and share (from 76% to 79%) of HFA inhalers. In fact, the number of DPI inhalers filled per month did not change during this period (~2.1 million throughout).

Conclusion/Discussion: Efforts to strengthen efforts to increase the use of asthma inhalers that do not have a high global warming potential, such as DPIs, are needed in the U.S. Such efforts include the development of more lower emission inhalers and DPI inhalers to promote their use.

Biography

Dima Mazen Qato, PharmD, MPH, PhD serves as the Hygeia Centennial Chair and Associate Professor (with tenure) in the Titus Family Department of Clinical Pharmacy. She has also been appointed as a Senior Fellow with the Leonard D. Schaeffer Center for Health Policy and Economics and is leading the Program on Medicines and Public Health. Dr. Qato received her PharmD from UIC, an MPH from the Johns Hopkins School of Public Health and a PhD in Public Health from the University of Illinois School of Public Health. At the USC Mann School of Pharmacy and Pharmaceutical Sciences, she will develop and lead interdisciplinary research efforts focusing on drug utilization, access to medicines, and pharmaceutical policy both in the U.S. and globally to better understand why medications are used, or not used, and how they can and should be used in the population to promote equity, longevity and good health.
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Dr. Chun-Tse Hung
Taipei Medical University

Reliever use and asthma control among U.S. adults with asthma, 2007-2020

Abstract

- Introduction
Asthma is one of the most common respiratory illnesses in the United States. Patients with poorly controlled asthma may experience symptoms of asthma attacks, such as shortness of breath. In such cases, relievers are used to quickly alleviate patient’s symptoms. However, trends in reliever use among adults with asthma have not been well-documented in recent years. Moreover, reliever use may indicate patients’ asthma control status.

- Aims
To (1) examine national trends in reliever use and asthma control, and (2) identify characteristics associated with reliever use among U.S. adults with asthma.

- Methods
Data from the 2007-2020 U.S. National Health and Nutrition Examination Survey were used. Adults with asthma aged at least 18 years were included as the study population. Relievers included short-acting beta agonists, short-acting muscarinic antagonists, and inhaled corticosteroid/formoterol. Asthma control was defined by the presence of asthma attacks and emergency room visits for asthma. Joinpoint regression analysis was conducted to evaluate trends in reliever use and asthma control. Multivariable logistic regression models were used to identify factors associated with reliever use.

- Results
From 2007 to 2020, there was a significantly decreasing trend in reliever use (average annual percent change [AAPC], -10.16; 95% CI, -19.35~-3.55). Decreasing trends were also observed in both asthma attacks (AAPC, -1.34; 95% CI, -5.08~2.43) and emergency room visits for asthma (AAPC, -14.64; 95% CI, -30.27~4.11). Several characteristics, including poor asthma control, older age, former and current smoking status, and having health insurance coverage, were associated with increased odds of reliever use among U.S. adults with asthma.

- Discussion/Conclusion
There is a declining trend in reliever use among U.S. adults with asthma, which might be reflected on improvements in asthma control. Disparities in reliever use still exist across several characteristics, highlighting the need for tailored interventions in clinical practice.

Biography

Chun-Tse Hung, Pharm.D. comes from School of Pharmacy, Taipei Medical University, Taiwan. Currently, he is a researcher and graduate student in School of Pharmacy, Taipei Medical University. His research interests focus on pharmacoepidemiology, claims data, and national surveys. He has two SCI publications using national health interivew survey, which demonstrated findings regarding (1) long COVID and (2) telemedicine use among U.S. adults with asthma.
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Mr. SANJAY J
Research Scholar
JSS College of Pharmacy, JSS Academy of higher education and research, Mysuru, India

Development of pulsatile drug delivery system of Bambuterol for treatment of Asthma

Abstract

Introduction: Pulsatile drug delivery systems (PDDS) offer advantages over conventional dosage forms by providing delayed, rapid, and instant drug release. This makes PDDS ideal for diseases like bronchial asthma, which has symptoms recurring at night or early morning. This study develops a pulsincap formulation targeting the gastrointestinal tract (GIT) with bambuterol hydrochloride (BHC) to optimize asthma treatment through controlled and targeted drug release.
Aim: To design and develop a pulsatile drug delivery system of bambuterol for treating Asthma.
Methods: Capsules body were treated with formaldehyde to harden them and protect them from fast dissolving, the granules of BHC were prepared by wet granulation method, and they were checked for preformulation evaluation studies. Drug-Excipient study by FTIR, evaluation of prepared DDS analysis including in vitro drug release studies.
Results: FTIR studies confirmed no interaction between the polymer and BHC, indicating component compatibility. Preformulation studies showed good flow properties of the granules. The in vitro release profile of BHC granules revealed rapid drug release, with formulation F6 (20 mg crospovidone) achieving 95.65% release within 15 minutes. The modified pulsincap formulation (F6-P5), with karaya gum and lactose, demonstrated a 5-hour lag time, achieving 91.87% drug release by the 9th hour. This study highlights the potential of BHC granules for effective GIT targeting.
Discussion: The research demonstrates the feasibility and efficacy of utilizing pulsincap technology for the pulsatile delivery of BHC to the GIT, offering a promising avenue for improving asthma management. The findings highlight the significance of lag time in achieving controlled drug release and in optimizing drug formulations for targeted delivery.
Keywords: Pulsin cap, Lag time, Gastrointestinal targeting, Formaldehyde treatment.

Biography

Sanjay J is a PhD research scholar in department of Pharmaceutics at JSS College of Pharmacy, Mysuru, India. His research focuses on the development of novel approach for the treatment of cervical cancer. He holds a Master of Pharmacy degree in Pharmaceutics department and a Bachelor of Pharmacy degree form Sree Siddaganga College of Pharmacy. Had done a project work on digital transformation in pharmaceutical marketing and have a hands-on training on Pharmacovigilance organized by AMC at Sree Siddaganga College Of pharmacy and procured a certificate through online live web and assessment on pharmacovigilance course.
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Mr Kuan Peng
PhD candidate
University of Hong Kong

Machine learning predicting risk of infection among patients treated with b/ts DMARDs

Abstract

Introduction: Biological and targeted synthetic disease-modifying anti-rheumatic drugs (b/ts DMARDs) are effective treatments for rheumatoid arthritis (RA). However, the use of b/ts DMARDs is associated with an increased risk of opportunistic infections.
Aims: This study aims to develop a machine-learning model to predict the risk of hospitalized infections following the initiation of b/ts DMARDs in arthritis patients.
Methods: Models were trained on RA patients newly initiated with b/ts DMARDs extracted from the Hong Kong electronic medical records (EMR) database. The primary outcome was hospitalized infection within one year after b/ts DMARDs initiation. Machine learning algorithms, including random forest, neural network, and XGBoost, were adapted to classify patients’ risk of infection with performance measured by area under the receiver operating characteristic (AUROC). Predictive features included demographic, co-morbidity, co-medication, and laboratory results. Recursive feature elimination was applied to determine the most predictive set of features. Shapley values were used to explain the contribution of features to model predictions.
Results: In total, we identified 3143 patients newly prescribed with b/ts DMARDs during the study period, of whom 297 have recorded hospitalized infections during the observation period. History of infection, b/ts DMARDs mode of actions, co-prescription of prednisolone, opioid, methotrexate, age, level of red blood cell counts, and C-reactive protein and Hypertension were selected as predictive features. The neural network had the greatest AUROC of 0.76 (95%CI: 0.69-0.83) compared with random forest 0.73 (95%CI: 0.65-0.81) and XGBoost 0.71 (95%CI: 0.63-0.79). Shapley values illustrated that the top three impactful predictive features were history of infection, age, and serum level of C-reactive protein.
Discussion: We developed a predictive machine learning model for b/ts DMARDs-induced infection based on the EMR database. The developed prediction tool will be able to identify high-risk patients and support the early prevention of severe infection among patients with immunocompromised conditions.

Biography

PhD candidate in pharmacoeconomics and pharmacoepidemiology Department of Medicine, LKS Faculty of Medicine, University of Hong Kong
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Mr. Chuan-Wei Shen
School of Pharmacy, Kaohsiung Medical University

Investigating NAFLD Patient Phenotypes in Southern Taiwan Using Machine Learning-based Cluster Analysis

Abstract

Introduction:
Non-alcoholic fatty liver disease (NAFLD) is a common liver disease in clinical settings, leading to the subsequent development of liver cirrhosis or hepatic cancer, decreasing patients’ life expectancy and deteriorating quality of life. In recent years, machine learning has been widely used in medical research. Cluster analysis can be applied to discover group phenotypes with similar characteristics within a population.

Aims:
This study aimed to identify NAFLD patients' phenotypes using cluster analysis.

Methods:
A retrospective cross-sectional study was conducted with a multiple-center database between 2016 and 2022. Patients diagnosed with NAFLD were included. K-prototypes, an unsupervised machine learning-based cluster analysis was used to cluster the patient characteristics, including comorbidity, comedication, and healthcare utilization records in a 365-day characteristic tracking period.

Results:
During the inclusion period from 2017 to 2021, we included 6,008 patients in the NAFLD cohort. Four clusters were built according to the algorithm. Cluster 1 (n=807) comprised the oldest patients with a median age of 68.1 years. This cluster has the highest proportion of diseases, including hypertension (62.2%), type 2 diabetes mellitus (53.4%), and heart failure (9.8%). Cluster 2 (n=2,504) was the healthiest group, exhibiting the lowest comedication use. Cluster 3 (n=2,345) tended to have gastrointestinal issues, with upper (21.9%) and lower (10.2%) gastrointestinal endoscopy records and increased use of agents against reflux diseases. Patients in cluster 4 (n=352) were the youngest, however, presented with chronic viral hepatitis (16.5%), hepatic failure (4.6%), and anemias (12.5%).

Discussion:
In this study, we identified characteristics of NAFLD patients, noting disproportionate comorbidities, especially in cluster 1. Further research will measure associations between NAFLD clusters and hepatic cancer. Leveraging big data management, we navigate medical records more efficiently than traditional methods, allowing the exploration of disease development networks with more potential factors.

Keywords: NAFLD, machine learning

Biography

Chuan-Wei graduated from the School of Pharmacy, KMU, and got a hospital and community pharmacist internship background. He then trained with epidemiology, pharmacoepidemiology, and HEOR research methodology in his master program in clinical pharmacy. He’s now a PhD candidate at the School of Pharmacy, focusing on pharmacoepidemiology research about cardiovascular and chronic lung diseases. He’s a clinical pharmacy researcher and SAS advocator, trying to become a database scientist and RWD/RWE expert.
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PhD Shinsuke Ohnuki
Real World Data Scientist
EPS Corporation

ePhenotyping: machine learning approach for defining diabetic kidney disease as an outcome

Abstract

[Introduction] Outcomes in the pharmacoepidemiologic studies are used for identifying the target patients contracting the disease of interest. True condition of the patients is defined by multiple features including confirmed diagnosis, related prescriptions, medical practices, etc. This is called "ePhenotyping" when using the electronic health records, receipt data, etc. as the data sources.In the post marketing surveillance (PMS) based on the real-world data, laboratory test value (LTV) facilitates outcome definition, but currently not enough available in many databases. Taking a kidney disease in PMS for example, without the LTV, identification of patients with the true condition is difficult or become dubious.
[Aims] Here, to address this issue, we tested ePhenotyping for Diabetic Kidney Disease (DKD) if DKD patients are accurately identified without the LTV, where the patient group is often focused on as the target of the PMS.
[Methods] Firstly, 11,468 diabetic patients with eGFR < 30 were selected as a gold standard of the DKD patient from the RWD database. Similarly, 11,468 diabetic patients with eGFR > 30 were randomly selected as a non DKD patient. Then, those were divided into two datasets (training data and test data) including 5,734 of DKD and non DKD patients, respectively. Finally, prescription drugs, medical practices, and definitive diagnosis from one month before to after the date when eGFR met the criteria were incorporated into modeling the classifier for the DKD patients.
[Results] With the supervised machine learning approaches including gradient boosting decision tree, we found the DKD patients are identified at 0.83 of PPV and 0.79 of sensitivity.
[Discussion] In this study, we concluded the ePhenotyping enables us to define outcomes accurately identifying DKD patients. Clinical implications and validity for the selected variables remained to be discussed with clinicians, and the models are kept optimizing for more valid assessment for the future.

Biography

Presenter got PhD in life science at the University of Tokyo, 2010, and engaged yeast genetics, genomics, and systems biology for more than 15 years. In current position, presenter have engaged pharmacoepidemiologic database studies and post marketing surveillance using several medical databases.
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Dr. Yunfeng Lai
Guangzhou University of Chinese Medicine

Research on the evidence development of benefit-risk in TCM formula granules

Abstract

Introduction: Traditional Chinese medicine (TCM) formula granules are extracted, concentrated, separated, dried, and granulated into granular preparations available for use in Chinese medicine clinics, which are convenient to take and suitable for industrial production, and are an important innovation in traditional Chinese medicine. In the last decade, relevant studies have mainly focused on the efficacy and safety of TCM formula granules but lacked a systematic study on their economics, especially benefit-risk.
Aims: This study will comprehensively assess the status of benefit-risk evidence development for TCM formula granules to provide an evidence-based basis for clinical selection and decision-making.
Methods: CNKI, Wanfang, PubMed, Web of Science, and Embase were searched up to 10 April 2024. Retrospective or prospective studies evaluating the cost-effectiveness of patients receiving TCM formula granules were included. We extracted data on the target patients, study design, interventions, clinical outcomes, costs and other indicators to analyze the characterization, study quality, and evidence development.
Results: 13 studies were finally included. There were 1 retrospective cohort study and 12 prospective cohort studies with a total of 1,073 patients. The CHEERS score grades were low. The evidence of clinical outcomes showed that most of the TCM formula granules had high efficacy rates. The safety evidence showed that there were no significant adverse reactions to the TCM formula granules. The TCM formula granules had a significant cost-effectiveness advantage was evident.
Discussion: TCM formula granules are being widely used in clinical practice, but there is still a need to vigorously develop evidence on the benefit-risk from the perspective of pharmacoeconomics. More high-quality evidence of benefits-risks is needed in the future to assist clinical and regulatory decision-making in TCM formula granules.

Biography

The primary research areas include pharmacoepidemiology, pharmacoeconomics, digital health, and regulatory science. He has led or participated in 16 academic projects, published 45 scholarly papers in SCI/SSCI indexed journals (21 as first author or corresponding author), and published 8 research papers in Chinese core journals (5 as first author or corresponding author). He has contributed to writing several academic monographs including the "Technical Manual for the Economic Evaluation of Chinese Patent Medicines". He serves as a youth editorial board member for the SCI-indexed "Chinese Medicine" journal. He also serves as a member of the Youth Committee of the 10th DAB Guangdong Provincial Committee, a member of the Expert Advisory Committee on the Application of Real-World Data for Health Care in Hainan, deputy director of the Youth Committee of the Humanities and Management Branch of Chinese medicine, deputy researcher of the International Research Center for Medicinal Administration at Peking University.
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Raghava Kalyan Maddukuri
Assistant Professor
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences

Quality of Life in Post Stroke Patients: Impact of Clinical factors.

Abstract

Aim: The study was aimed to assess the overall impact of stroke on health related quality of life (QoL) and associate it with clinical and socio-demographic characteristics of patients.

Methodology: This prospective observational study was carried out at a tertiary care hospital for a period of 2 years. Parameters like National Institute of Health Stroke Scale (NIHSS), Stroke Specific Quality of Life (SS-QoL), Modified Ranking Scale (mRS) and Mini Mental State Examination (MMSE) were used to assess the clinical aspects of stroke and correlate with quality-of-life in post stroke survivors.

Results: Among 117 stroke patients followed for a period of 6 months, with a mean age of 57.58±10.26 years, the mean SS-QoL score was found to be 202.31 (95%CI: 192.39 to 212.23) indicating a better quality of life. Several domains of QoL were affected, the most affected domains being family roles (74.7%), energy (75%), and work/productivity (75%). The least affected domains were language (89.76%) and self-care (89.2%). We observed a significant negative correlation between SS-QoL and mRS scores (r = -0.926, 95% CI: -0.95 to-0.89; p=˂0.001), indicating a decreased QoL with an increased degree of disability. Similarly, QoL was again negatively correlated to severity of stroke at the time admission (r = -0.86; p=˂0.001). Patients with Total Anterior Circulation infarct subtype of stroke had a significant reduction in QoL.

Conclusion: This present study observed a better quality of life among stroke survivors. We observed an inversely proportional relationship between severity of stroke at the time of admission, disability post stroke and QoL. Identifications of factors contributing to severity and disability and making any possible interventions can enhance QoL in patients with stroke.

Key words: Stroke; Stroke Specific Quality of Life; Disability; Negative Correlation.

Biography

Currently working as Assistant professor in the department of Pharmacy Practice, I am a Pharmaco-epidemiology enthusiast. Automated and Hospital and databases as a source of data for pharmacoepidemiology is something that i am willing to explore in the near days. Pharmaco-epidemiologic methods are my strength and i willing to apply all these methods with vast sources of data that are available in all these databases.
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Kazuhiko Takahata
Department of Public Health and Epidemiology, Meiji Pharmaceutical University

Health economic evaluation of self-injection of biologics in patients with rheumatoid arthritis.

Abstract

Introduction:
Biological disease-modifying antirheumatic drugs (bDMARDs) have high effectiveness in patients with rheumatoid arthritis (RA), whereas, there are concerns about their high costs. However, it has not yet been evaluated whether self-injection (SI) of bDMARDs enables patients to reduce the frequency of hospital visits and direct medical costs or not.

Aims:
To evaluate the impact of SI on medical cost in patients with RA by comparing drug cost between patients who have selected SI and those who had not.

Methods:
We conducted a retrospective cohort study using claims data from April 2014 to September 2021, which was provided from DeSC Healthcare, Inc. We defined patients with RA by both disease code and bDMARDs prescription and classified patients who have selected SI (SI group) and those who had not (non-SI group). Patients’ characteristics were used to calculate a propensity score. One-to-one matching was performed, and we calculated the average of drug cost from the public healthcare payer's perspective in JPY/person/year in each group.

Results:
Total of 3,972 patients (mean age:72.5 years, female:73.3%) were matched and the total drug cost and bDMARDs cost were ¥1,020,387 and ¥939,950 (JPY/person /year) in the SI group, ¥589,712 and ¥465,175 (JPY/person/year) in the non-SI group, respectively (I USD = 110 JPY in 2021). The proportion of bDMARDs cost relative to total drug cost in the SI group (92.1%) were higher than that in the non-SI group (78.9%).

Discussion:
This study shows the higher total drug cost in the SI group compared to the non-SI group. To evaluate the health economic benefits of SI in patients with RA from the public healthcare payer’s perspective, it is necessary to consider not only medical costs, but also the frequency of hospital visits and employed status.

Biography

JOB EXPERIENCE April 2020-Present Kyowa Kirin Co., LTD., Tokyo, Japan January 2019 – March 2020 BRISTOL-MYERS SQUIBB Tokyo, Japan April 2016 – December 2018 SANOFI K.K. Tokyo, Japan April 2009 – March 2016 ONO PHARMACEUTICAL CO., LTD., Osaka, Japan EDUCATION MEIJI PHARMACEUTICAL UNIVERSITY, Tokyo, Japan Pharmacy and Health Sciences (4-year Doctoral program), Candidate PhD, Oct 2022-Present TOKYO UNIVERSITY OF PHARMACY AND LIFE SCIENCE, Tokyo, Japan Master of Pharmacy, May 2009 Drug absorption and pharmacokinetics TOKYO UNIVERSITY OF PHARMACY AND LIFE SCIENCE, Tokyo, Japan Bachelor of Pharmacy, March 2007 HONORS AND AWARDS The Pharmaceutical Society of Japan Award for Kanto Branch (Oral Presentation), Sep-2023 ADDITIONAL INFORMATION • License of pharmacist, July 2007 • PMP (Project Management Professional), May 2018
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Zhaoyan Chen
West China Hospital of Sichuan University

Cost-effectiveness analysis of the first-line treatment with nivolumab plus ipilimumab in mesothelioma

Abstract

Introduction.Malignant Pleural Mesothelioma(MPM) is an uncommon tumour known as malignant pleural mesothelioma. The NCCN guidelines recommend immunotherapy and chemotherapy for the first-line treatment of unresectable malignant pleural mesothelioma, with special emphasis on immunotherapy in patients with non-epithelioid tumors.
Aims. This study's objective was to assess the cost-effectiveness of treating MPM in China using an Nivolumab(NIV) plus Ipilimumab(IPI) regimen.
Methods. The estimated findings came from a multicenter randomised phase III trial that demonstrated enhanced survival benefits for MPM patients receiving a combination NI treatment. To calculate the Incremental Cost-Effectiveness Ratio(ICER) from the viewpoint of Chinese society, a partitioned survival model was built. One-way certainty and probabilistic sensitivity analysis are used to resolve the uncertainty in the model.
Results. When compared to platinum plus pemetrexed chemotherapy, our base case study showed that the overall cost of treatment increased from $14448.212 to $158877.930 when the NI combo regimen was used. The effectiveness of NI combination therapy increased by 0.203 Quality-adjusted LifeYears(QALYs), from 0.601 QALYs to 0.804 QALYs. With a Willingness-To -Pay(WTP) threshold of $35856.90/QALY, the incremental cost-effectiveness ratio was $711476.442, and there was a 0% chance that it would be cost-effective.
Discussion. When considered as a whole, the findings of this study indicate that, from the standpoint of Chinese payers, the combination of NI is not a cost-effective alternative as a first-line therapy option for MPM.

Biography

Pharmacy Department, West China Hospital, Sichuan University, Senior Pharmacist, PhD Research focuses on evidence-based pharmacy and pharmacoeconomics Has hosted/participated in 5 national or provincial/ministerial longitudinal projects and 3 horizontal projects Has published 19 articles in the past three years, with 8 articles indexed in SCI (total impact factor: 63.36) Has co-authored/translated 2 pharmacy-related books Reviewer for journals such as JAMA network open, Journal of Cancer Research and Clinical Oncology, Frontiers in pharmacology, and Chinese Journal of Hospital Pharmacy Awards: Best Debater at the 2019 Forum on Rational Drug Use for the Elderly, Excellent Paper Award at the 2022 Forbidden City International Pharmacist Conference, etc.
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Jennifer James
Student
JSS COLLEGE of PHARMACY

Impact of CPE program on medication adherence among community pharmacists

Abstract

Introduction. Continuing Pharmacy Education (CPE) is essential for pharmacists to stay updated with the latest clinical knowledge and skills, directly impacting medication adherence practices.
Aims. To assess the impact of a CPE program on community pharmacists' knowledge and perceptions regarding medication adherence.
Methods. A prospective interventional study was carried out with 30 community pharmacists who underwent a CPE program focused on "Medication Adherence." The impact was assessed using a Knowledge, attitude, and practice ( KAP) questionnaire, validated through expert review and pilot testing, achieving a Cronbach's alpha score of 0.89 for reliability. Assessments were conducted before and one month after the program. Statistical analysis included a paired t-test to evaluate significant changes in knowledge, attitudes, and practices, with significance set at p < 0.05.
Results. Out of the 30 community pharmacists who participated in the CPE program, the majority of the community pharmacists were males (66.7%) and were aged between 20-30 years (70%). Among them, 76.7% were employees, with Diploma (86.7%) being the highest educational degree and working experience ranging from 0-5 years (63.3%). The paired t-test was conducted on the overall knowledge (p-value = 0.0023), attitude (p-value = 0.62), and practice (p-value = 0.09) questions separately. Community pharmacists show significant improvement in the knowledge section of medication adherence from 42% to 66.3% before and after the CPE program with a p-value < 0.05 (p-value = 0.0023). The average score value before the CPE program was 15.41 (SD ±2.9) and after the CPE program, it improved to 18.55 (SD ±3.3), with a statistically significant p-value of < 0.05 (p-value = 0.0003).
Discussion. The CPE program markedly improved pharmacists' understanding and practices of medication adherence, as validated by significant post-intervention improvements in KAP scores. This emphasizes the value of continuous ongoing education in enhancing pharmacy practice and patient care outcomes.

Abstract Document

Biography

Jennifer James is a passionate and driven clinical pharmacy student currently pursuing her Doctor of Pharmacy degree at Jss Academy of Higher Education and Research (JSSAHER). During her period of clinical postings, she has immersed herself in departmental rotations, ambulatory interactions with patients, and retail pharmacy training at a tertiary care center. She is committed to provide highest standard of care in her future professional assignments. She has been successful in achieving copyright approval for the Medstik tool that she devised for medication adherence during her project work. Outside of her academic pursuits, she actively engages herself in research projects, academic publications, and patient counseling. She is excited about the opportunities ahead and looks forward to contributing positively to the field of pharmacy practices.
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Miss IRENE LALHRUAIMAWII
Ph. D Scholar
MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES

ART Adherence and its Associated Barrier Experienced by PLHIV in Mizoram, India.

Abstract

Introduction: Antiretroviral Therapy (ART) has resulted in increasing the longevity of people living with HIV infection. Despite the current era of Anti-Retroviral Therapy (ART) available with free of cost in India, Non-Adherence (NA) remains a major encounter in real-life settings. Hence, identifying barriers to measure ART adherence is essential for treatment success. Therefore, the study is conducted to find out how well people living with HIV (PLHIV) are adhering to ART and what obstacles they face in highly HIV prevalent state in India.
Aims: The aim of the study is to assess the ART adherence among PLHIV in Aizawl, Mizoram and evaluate the Adherence barrier among PLHIV in Aizawl, Mizoram.
Methods: A cross-sectional study was conducted between January 2023 to May 2024 at ART Centres, Aizawl, Mizoram, India. A pre-tested questionnaire on Adherence Barrier Questionnaire (ABQ) Scale was administered after translating in local language. Medication adherence was assessed using Visual Analog Scale (VAS). Chi-square test and Mann Whitney U test was used for statistical analysis at a significance level of p<0.05.
Results: There was a total of 300 participants consisting of 176 (58.7%) male and 124 (41.3%) female. The mean score of Adherence to ART is 9.48 (SD±0.920) while the mean of total Adherence barrier score is 16.64 (SD ± 2.47). There was a significantly higher adherence barrier score among participants with low adherence (Mean 18.29, SD±3.12) followed by moderate adherence (Mean 17.19, SD±3.05) and good adherence (Mean 16.31, SD±2.08) across the ABQ domain. In addition, there was significantly higher unintentional adherence barrier score among the unemployed (Mean 8.64, SD±2.28) participants compared to the participants with jobs (Mean 8.25, SD±1.95)
Conclusion: The overall adherence to ART is satisfactory in the study center, and there is a low risk of adherence barrier with respect to the total ABQ scale.

Biography

I am presently doing my Ph.D. Research among people living with HIV focusing on HIV related Stigma, Antiretroviral therapy adherence, Adherence barrier and its association with Health-related Quality of Life in coastal Karnataka, and ART centers, Aizawl, Mizoram, India. My research work involves a substantial component of HIV and related aspects
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