Introduction: Individuals with type 1 diabetes mellitus (T1DM) are at increased risk of cardiovascular disease. However, specific evidence for statins in T1DM remains limited and is extrapolated from individuals with type 2 diabetes.

Aims: To evaluate the effectiveness and safety of statins in children and adults with T1DM.

Methods: We searched Medline and Embase from inception to 20 January 2026, with backwards citation searching of reference lists using Scopus. Randomized controlled trials (RCTs) with ≥1000 participants or individual participant data (IPD) meta analyses, and observational studies with ≥2 years of average follow up evaluating statin use in T1DM were eligible for inclusion. The primary outcomes were myocardial infarction, stroke, major adverse cardiovascular events (MACE), and all cause mortality. Secondary safety outcomes included myopathy, liver injury, and worsening of glucose control. Random-effects meta-analyses were performed to pool outcomes reported in at least two cohort studies.

Results: We included six studies of adults with T1DM, comprising five cohort studies (n=63,143) and one IPD meta-analysis of statin RCTs (n=1,466). Statins were associated with reductions in myocardial infarction (hazard ratio [HR] 0.75, 95% CI 0.67–0.85; 3 studies; I²=0.0%), stroke (HR 0.83, 95% CI 0.71–0.98; 2 studies; I²=38.4%), MACE (HR 0.80, 95% CI 0.73–0.87; 2 studies; I²=0.0%), and all-cause mortality (HR 0.64, 95% CI 0.49–0.85; 2 studies; I²=85.8%). In one study, statin use was associated with an increase in liver dysfunction but not myopathy. In another study, statins were associated with reduced insulin sensitivity.

Conclusions: Although the evidence of statin effectiveness and safety is largely derived from a limited number of observational studies, this evidence indicates that statins reduce cardiovascular events and mortality in adults with T1DM. Further research is needed to clarify the effectiveness and safety of statins in children and young adults.

Keywords: type 1 diabetes mellitus; statins; cardiovascular outcomes

Introduction: Tyrosine kinase inhibitors (TKIs) are the standard first-line treatment for chronic myeloid leukemia (CML), requiring long-term administration to sustain molecular remission and prevent relapse. As survival improves, metabolic adverse effects of TKIs, particularly second-generation agents, have become a clinical concern. However, evidence remains limited by small sample sizes, short follow-up duration, and methodological constraints, limiting comparisons of agent-specific metabolic risk.

Aims: This study investigated the incidence of type 2 diabetes mellitus (T2DM), hyperlipidemia, and hypertension among patients with CML treated with imatinib, nilotinib, or dasatinib.

Methods: This prevalent new-user, active-comparator, 1:1 propensity score-matched (PSM) cohort study used the National Health Insurance Research Database and Taiwan Cancer Registry to identify adults with newly diagnosed CML (2013-2023) who initiated nilotinib or dasatinib, including switchers from imatinib, matched to imatinib users by exposure duration. Incidence rate ratios and hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Poisson and Cox proportional hazards regression, respectively.

Results: Following PSM, the matched diabetes, hyperlipidemia, and hypertension cohorts comprised 552, 609, and 487 nilotinib users and 688, 725, and 598 dasatinib users, respectively. Compared with imatinib, nilotinib was associated with a significantly higher risk of incident hyperlipidemia (HR 3.08; 95% CI, 1.78-5.32), while its risks of T2DM and hypertension were not significantly different. Dasatinib was associated with a significantly lower risk of incident T2DM (HR 0.39; 95% CI, 0.19-0.78) and a significantly higher risk of hypertension (HR 1.82; 95% CI, 1.05-3.18), with no significant difference in hyperlipidemia risk (HR 1.43; 95% CI, 0.88-2.32).

Conclusions: Among patients with CML, nilotinib was associated with an increased risk of hyperlipidemia relative to imatinib, while dasatinib was associated with a lower risk of T2DM but a higher risk of hypertension. These findings support routine metabolic monitoring during CML treatment.

Keywords: Chronic myeloid leukemia; Tyrosine kinase inhibitors; Metabolic disease

Introduction: Timely treatment and prevention of over-granulating peritoneal dialysis (PD) exit site is warranted to mitigate risk of life-threatening complications. However, temporal patterns of granuloma recurrence post-treatment remained rarely described. Understanding of post-treatment recurrence rates over time is important to guide management strategies.

Aims: To characterise the temporal pattern of granuloma recurrence rates post-cauterisation (with silver nitrate/ diathermy) for over-granulating exit site in PD patients.

Methods: This ambispective study conducted in a tertiary hospital at Malaysia involved PD clinic patients with over-granulating exit site from Year 2021-2025 using self-controlled case series approach to eliminate residual time-invariant confounding and confounding by indication. Treatment details and clinical information were collected from the electronic medical records. Median time to recurrence and 95% confidence intervals (CIs) were estimated using Kaplan-Meier method. Incidence rate ratios (IRRs) and 95% CIs for recurrence of granuloma during each 6 weeks-interval risk period were estimated using conditional Poisson regression, with ≥30 weeks from treatment initiation as reference, using R 4.5.0.

Results: The study cohort of 358 patients consists of 339 (58.2%) episodes with silver nitrate (Avoca® Caustic Pencil 95%w/w Cutaneous Stick, Bray Healthcare, United Kingdom) and 243 (41.8%) episodes with diathermy. The median time to recurrence was 133 days (95% CI: 114-173) for diathermy and 118 days (95% CI: 108-133) for silver nitrate. A trend towards lower recurrence was observed for diathermy [1st-6th week (IRR 0.059, 95% CI: 0.026-0.133) & 7-12th week (0.586, 0.363-0.945)] that waned over time after 12 weeks (95% CIs crossed 1.0). Silver nitrate showed similar protective pattern [1st-6th week: 0.028, 0.010-0.074] with diminishing association over successive intervals after 6 weeks.

Conclusions: Lower recurrence of granuloma in PD patients was observed first 6 weeks post-treatment for silver nitrate and 12 weeks post-diathermy that waned thereafter. These findings warrant confirmation through prospective, multicentre comparative studies.

Introduction: Depression during pregnancy is increasingly common, and selective serotonin reuptake inhibitors (SSRIs) are often prescribed. Prior studies addressing confounding by indication have generally reported no significant association with major congenital malformations (MCMs). However, evidence remains limited, particularly in Japanese medical situation.

Aims: We evaluated the association between first-trimester SSRI exposure and MCMs in infants. This study provides real-world evidence from a large Japanese claims database.

Methods: This retrospective cohort study used a large claims database in Japan from 2010 to 2024. Dates of pregnancy onset and delivery were estimated using validated algorithms, and overall MCMs were defined according to the International Classification of Diseases, 10th revision codes. To address confounding by indication, the analysis was restricted to pregnant women with diagnosed depression before the end of the first trimester. We compared MCM prevalence between infants born to women with and without first-trimester SSRI exposure and estimated weighted odds ratios (wORs) using propensity score–based overlap weighting.

Results: Among 185,513 women who delivered between 2010 and 2024, 5,995 had a diagnosis of depression before the end of the first trimester. Of these, 1,072 were exposed to SSRIs during the first trimester. The prevalence of overall MCMs in infants was 8.4% (370/4,429) among unexposed women and 8.1% (87/1,072) among exposed women. First-trimester SSRI exposure was not significantly associated with overall MCMs (wOR 0.969, 95% confidence interval: 0.751–1.249). Results were consistent across multiple sensitivity analyses, including restriction to women prescribed SSRIs for ≥30 days during the first trimester, change of the exposure window ±7 days, and exclusion of women with potential teratogenic conditions.

Conclusions: Exposure to SSRIs during the first trimester of pregnancy was not associated with an increased risk of overall MCMs in infants. Further evaluation of other outcomes such as neurodevelopmental disorders is warranted.

Keywords: SSRIs, pregnancy, major congenital malformations

Background
Methylphenidate (MPH) and modafinil are central-nervous-system stimulants prescribed for narcolepsy. Both agents raise sympathetic tone, yet their cardiovascular safety in patients with narcolepsy remains uncertain, and conventional cohort designs are vulnerable to between-person confounding.
Objectives
To quantify the within-person risk of incident cardiovascular events during exposure to MPH and modafinil in patients with narcolepsy, using a self-controlled case series design that eliminates time-invariant confounding.
Methods
Using Taiwan's National Health Insurance Research Database, we identified patients with narcolepsy who experienced a cardiovascular event and received MPH or modafinil. Person-time was divided into baseline (reference), pre-exposure (1–30 d), exposed (1–7, 8–14, 15–28, 29–56, >56 d) and washout (1–28 d) windows. Conditional Poisson regression estimated crude and adjusted incidence rate ratios (aIRR) with 95% confidence intervals.
Results
A total of 405 MPH users and 105 modafinil users were identified in the analysis. For MPH, risk of cardiovascular event rose sharply in the 30 days preceding initiation (aIRR 7.93, 95% CI 5.48–11.48) and in the first week of exposure (aIRR 1.73, 1.05–2.83). Risk returned to baseline thereafter. Modafinil showed a similar pattern, elevated point estimates in the pre-exposure window (aIRR 1.97, 0.47–8.19) and during early exposure (aIRR 1.35, 0.54–3.40) with limited statistical power.
Conclusions
In patients with narcolepsy, MPH was associated with a transient excess of cardiovascular events during the first week of treatment, with a striking pre-exposure spike. Clinicians should monitor cardiovascular status closely when initiating stimulants.
Keywords
narcolepsy; methylphenidate; modafinil; cardiovascular events.

Introduction: Cardiovascular risk models relying on 10-year predictions mask the cumulative lifetime risk in young adults with diabetes mellitus. Consequently, this demographic remains systematically undertreated in primary care. This persists despite an escalating premature cardiovascular disease burden.

Aims: We aimed to evaluate the effectiveness and safety of early statin initiation for primary prevention in young adults with diabetes. Specifically, we estimated intention-to-treat and per-protocol effects of sustained therapy.

Methods: We emulated a target trial using primary care electronic health records, including 13,602 person-trials of adults aged 18–39 with diabetes and low-density lipoprotein cholesterol ≥2.6 mmol/L. Statin initiators were matched 1:4 with non-initiators via propensity scores using a sequential trial approach. Pooled logistic models with stabilized inverse probability of censoring weights estimated intention-to-treat (ITT) and per-protocol effects. Outcomes included all-cause mortality, major cardiovascular disease (CVD), myocardial infarction (MI), stroke, and heart failure.

Results: Over a median 8-year follow-up, ITT analysis showed statin initiation significantly reduced MI risk (HR 0.736, 95% CI 0.548–0.989). However, it did not significantly reduce the primary composite of major CVD or all-cause mortality (HR 0.957, 95% CI 0.829–1.105). Real-world treatment deviation was substantial, as approximately 50% of initiators discontinued therapy. In the per-protocol analysis evaluating sustained adherence, statin therapy profoundly reduced the composite risk of all-cause mortality or major CVD (HR 0.754, 95% CI 0.619–0.920, 10-year absolute risk reduction: -2.13%). Sustained therapy also reduced major CVD alone (HR 0.739, 95% CI 0.574–0.950) and MI (HR 0.647, 95% CI 0.436–0.959). Adverse hepatic or muscular events did not increase.

Conclusions: Statin initiation in young adults with diabetes is safe and beneficial when therapy is sustained. To curb premature CVD trends, primary care strategies should evolve beyond initial prescriptions. Interventions should prioritize long-term adherence to address the 50% discontinuation rate observed in routine practice.

Keywords: Statins, Diabetes mellitus, Young adults

Introduction: Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate targeting HER2. The DESTINY-Lung01 trial demonstrated strong efficacy in metastatic NSCLC patients with HER2 mutation or amplification. However, real-world data regarding its effectiveness and safety in Asian populations remain limited.

Aims: This study aimed to characterize the real-world effectiveness and safety of T-DXd within a Taiwanese NSCLC cohort.

Methods: We conducted a retrospective cohort study analyzing electronic medical data from metastatic NSCLC patients who received T-DXd between April 2022 and May 2026. To isolate true T-DXd-induced ILD, only events occurring after T-DXd initiation were attributed to T-DXd, excluding patients with pre-existing ILD or ILD from prior therapies. Confirmation required CT imaging or bronchoalveolar lavage to exclude infectious etiologies. Prognostic factors including prior lines of therapy, metastatic burden, and HER2 alteration type were evaluated.

Results: A total of 52 patients were included (mean age 61.2 years; 55.8% female), with a median of 1 prior line before T-DXd initiation. Median OS was 7.7 months (95% CI: 4.3–13.7), with T-DXd-induced ILD confirmed in 13.5% of patients. Patients receiving T-DXd within 3 total lines (n=37, 71.2%) had a median OS of 10.3 months (95% CI: 7.0–21.4) versus 2.5 months (95% CI: 0.2–6.9) beyond 3 total lines (n=15, 28.8%). HER2-mutated patients (n=35, 67.3%) achieved a median OS of 10.0 months (95% CI: 6.1–19.6) compared to 2.1 months (95% CI: 0.5–6.9) in HER2-amplified patients (n=10, 19.2%). Patients without brain metastases (n=35, 67.3%) had a median OS of 10.0 months versus 7.7 months (95% CI: 2.6–13.7) in those with brain metastases (n=17, 32.7%).

Conclusions: Real-world outcomes were significantly inferior to DESTINY-Lung01, with a median OS of 7.7 versus 17.8 months. Patient selection for T-DXd therapy warrants further optimization. The ILD rate of 13.5% remained consistent with clinical trial observations.

Keywords: trastuzumab deruxtecan, non-small cell lung cancer, real-world evidence