Cardiovascular Effectiveness of Semaglutide Versus Dulaglutide in Type 2 Diabetes.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-12-01 DOI:10.1002/pds.70276

Kasper Bonnesen, Uffe Heide-Jørgensen, Diana H Christensen, Timothy L Lash, Lars Pedersen, Reimar W Thomsen, Anthony A Matthews, Morten Schmidt

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引用次数: 0

Abstract

Objective: Randomized clinical trials show that subcutaneous semaglutide is modestly superior to dulaglutide in reducing HbA1c and body weight, but no trial has compared their effectiveness on hard cardiovascular outcomes. This study aimed to examine whether semaglutide and dulaglutide differ in cardiovascular effectiveness.

Research design and methods: This new-user, active-comparator cohort study used nationwide population-based Danish healthcare data to emulate a target trial of adults with type 2 diabetes receiving standard care who initiated subcutaneous semaglutide compared with dulaglutide. Up to five semaglutide initiators were matched to one dulaglutide initiator on a propensity score estimated from 52 variables. The outcome was a major adverse cardiovascular event (MACE), including myocardial infarction, ischemic stroke, heart failure, coronary revascularization, and cardiovascular death. In per-protocol analyses, Aalen-Johansen estimates were used to calculate risks, risk differences, and risk ratios at 3 years, accounting for informative censoring at nonadherence to the assigned treatment via time-varying inverse probability of censoring weights.

Results: The semaglutide group included 2535 individuals, and the dulaglutide group 569 (median age [IQR], 61 [52-71] years; 1105 female individuals [36%]). Within 3 years, the risk of MACE was 6.0% (95% CI, 4.5%-7.8%) in the semaglutide group and 6.2% (95% CI, 4.0%-8.9%) in the dulaglutide group, corresponding to a risk difference of -0.2% (95% CI, -3.2% to 2.8%) and a risk ratio of 0.97 (95% CI, 0.59-1.61).

Conclusions: This target trial emulation did not provide evidence for a substantial difference in cardiovascular outcomes between individuals with type 2 diabetes initiating semaglutide and dulaglutide.

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西马鲁肽与杜拉鲁肽治疗2型糖尿病的心血管疗效。

目的：随机临床试验显示，皮下使用semaglutide在降低HbA1c和体重方面略优于dulaglutide，但没有试验比较它们对硬心血管结局的有效性。本研究旨在检验西马鲁肽和杜拉鲁肽在心血管疗效上是否存在差异。研究设计和方法：这项新用户、主动比较者队列研究使用了基于全国人口的丹麦医疗保健数据，模拟了一项针对接受标准治疗的成人2型糖尿病患者的目标试验，这些患者开始皮下注射西马鲁肽与杜拉鲁肽进行比较。根据52个变量估计的倾向得分，多达5个半马鲁肽引发剂与1个杜拉鲁肽引发剂相匹配。结果为主要不良心血管事件（MACE），包括心肌梗死、缺血性卒中、心力衰竭、冠状动脉血运重建术和心血管死亡。在每个方案分析中，aallen - johansen估计用于计算3年的风险、风险差异和风险比，通过审查权的时变逆概率对不遵守指定治疗进行信息审查。结果：西马鲁肽组2535例，杜拉鲁肽组569例（中位年龄[IQR]， 61[52-71]岁；女性1105例[36%]）。在3年内，semaglutide组的MACE风险为6.0% (95% CI, 4.5%-7.8%)， dulaglutide组的MACE风险为6.2% (95% CI, 4.0%-8.9%)，对应的风险差异为-0.2% (95% CI, -3.2% - 2.8%)，风险比为0.97 （95% CI, 0.59-1.61）。结论：这项目标试验模拟并没有提供证据表明，在2型糖尿病患者中，使用西马鲁肽和杜拉鲁肽在心血管结局方面存在实质性差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.