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“Clinical Research Bites” – 2026/5
22. 1. 2026
Today’s “bites” are devoted almost entirely to cardiovascular health and prevention.
Meta-analysis of the Benefits and Risks of GLP-1RAs in a 100,000-Patient Cohort
A meta-analysis of 21 studies including 99,599 patients treated with eight different glucagon-like peptide-1 receptor agonists (GLP-1RAs; lixisenatide, liraglutide, exenatide, semaglutide, efpeglenatide, dulaglutide, albiglutide, and tirzepatide) at therapeutic doses, compared with control groups (placebo or active comparator), with a mean follow-up of 2.4 years, provided highly robust evidence that these drugs reduce all-cause mortality (incidence rate ratio [IRR] 0.88; 95% confidence interval [CI] 0.84–0.92; number needed to treat [NNT] 121), cardiovascular (CV) mortality (IRR 0.87; 95% CI 0.81–0.92; NNT 170), and the risk of major adverse cardiovascular events (MACE) (IRR 0.87; 95% CI 0.83–0.91; NNT 66). GLP-1RAs reduced the risk of myocardial infarction (MI) by 15%, acute kidney injury (AKI) by 9%, heart failure (HF) by 15%, and infections by 10%. In contrast, they increased the risk of gastrointestinal disorders by 63% and gallbladder disease by 26%. They had no effect on the incidence of stroke, pancreatitis, or neoplasms. Potential differences in efficacy and safety were identified among individual agents.
Source: Galli M., Benenati S., Laudani C. et al. Cardiovascular effects and tolerability of GLP-1 receptor agonists: a systematic review and meta-analysis of 99,599 patients. J Am Coll Cardiol 2025; 86 (20): 1805–1819, doi: 10.1016/j.jacc.2025.08.027.
First Representative of the FXIa Inhibitor Class in Secondary Prevention of Ischemic Stroke
In November 2025, favorable results of the OCEANIC-STROKE trial were announced. In this study, the oral coagulation factor XIa inhibitor asundexian (50 mg once daily), added to antiplatelet therapy, led to a significant reduction in the risk of ischemic stroke compared with placebo in patients with a history of non-cardioembolic ischemic stroke or with high-risk transient ischemic attack (TIA). Treatment with asundexian was not associated with an increased risk of major bleeding as defined by the criteria of the International Society on Thrombosis and Haemostasis (ISTH). The results will be presented at scientific congresses and used in the regulatory submission for this drug.
Source: Bayer’s asundexian met primary efficacy and safety endpoints in landmark phase III OCEANIC-STROKE study in secondary stroke prevention. Bayer, November 23, 2025. Available at: www.bayer.com/en/us/news-stories/oceanic-stroke
High-Sensitivity CRP as an Independent Cardiovascular Risk Factor
The American College of Cardiology (ACC) recently published a statement highlighting the crucial role of chronic low-grade inflammation in the pathogenesis of cardiovascular disease. It notes that high-sensitivity C-reactive protein (hsCRP) is a strong predictor of recurrent cardiovascular events, even in patients treated with statins, and that elevated hsCRP levels in otherwise healthy individuals place them in a higher cardiovascular risk category despite normal cholesterol levels.
Source: Mensah G. A., Arnold N., Prabhu S. D. et al. Inflammation and cardiovascular disease: 2025 ACC scientific statement: a report of the American College of Cardiology. J Am Coll Cardiol 2025: S0735-1097(25)07555-2, doi: 10.1016/j.jacc.2025.08.047 [Epub ahead of print].
Elevated LDH Levels Are Associated With Worse Prognosis in Patients With Heart Failure
Lactate dehydrogenase (LDH) is a nonspecific marker of cellular injury and may have prognostic significance in heart failure with reduced ejection fraction (HFrEF). An analysis of data from the randomized, placebo-controlled GALACTIC-HF trial, which evaluated the efficacy and safety of omecamtiv mecarbil in 8,179 patients with HFrEF, showed that increasing LDH levels were associated with a higher risk of first HF event or cardiovascular death (the composite endpoint). Compared with patients in the lowest LDH quartile (mean 155 U/L), patients in the second quartile (mean 183 U/L) had a 15% higher risk (hazard ratio [HR] 1.15; 95% CI 1.02–1.31), those in the third quartile (mean 207 U/L) a 39% higher risk (HR 1.39; 95% CI 1.23–1.58), and those in the highest quartile (mean 253 U/L) an 84% higher risk (HR 1.84; 95% CI 1.62–2.08). Even after adjustment for potential confounders, elevated LDH levels remained significantly associated with an increased risk of this composite outcome.
Source: Ono R., Chimura M., Docherty K. F. et al. Lactate dehydrogenase and outcomes in patients with HF and reduced ejection fraction: insights from GALACTIC-HF. JACC Heart Fail 2026 Jan 10 : 102900, doi: 10.1016/j.jchf.2025.102900 [Epub ahead of print].
Editorial Team, Medscope.pro
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