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度拉鲁肽对伴有和不伴有心力衰竭的患者的心血管和心力衰竭结局的影响:来自 REWIND 随机试验的事后分析。

Dulaglutide and cardiovascular and heart failure outcomes in patients with and without heart failure: a post-hoc analysis from the REWIND randomized trial.

机构信息

University of Washington Heart Institute, Seattle, WA, USA.

Institut Universitaire de Cardiologie et Pneumologie de Québec, Université Laval, Québec City, Québec, Canada.

出版信息

Eur J Heart Fail. 2022 Oct;24(10):1805-1812. doi: 10.1002/ejhf.2670. Epub 2022 Sep 20.

Abstract

AIMS

People with diabetes are at high risk for cardiovascular events including heart failure (HF). We examined the effect of the glucagon-like peptide 1 agonist dulaglutide on incident HF events and other cardiovascular outcomes in those with or without prior HF in the randomized placebo-controlled Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.

METHODS AND RESULTS

The REWIND major adverse cardiovascular event (MACE) outcome was the first occurrence of a composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes). In this post-hoc analysis, a HF event was defined as an adjudication-confirmed hospitalization or urgent evaluation for HF. Of the 9901 participants studied over a median follow-up of 5.4 years, 213/4949 (4.3%) randomly assigned to dulaglutide and 226/4952 (4.6%) participants assigned to placebo experienced a HF event (hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.77-1.12; p = 0.456). In the 853 (8.6%) participants with HF at baseline, there was no change in either MACE or HF events with dulaglutide as compared to participants without HF (p = 0.44 and 0.19 for interaction, respectively). Combined cardiovascular death and HF events were marginally reduced with dulaglutide compared to placebo (HR 0.88, 95% CI 0.78-1.00; p = 0.050) but unchanged in patients with and without HF at baseline (p = 0.31).

CONCLUSIONS

Dulaglutide was not associated with a reduction in HF events in patients with type 2 diabetes regardless of baseline HF status over 5.4 years of follow-up.

摘要

目的

患有糖尿病的人患心血管事件(包括心力衰竭[HF])的风险很高。我们在随机安慰剂对照的糖尿病每周肠降血糖素治疗心血管事件研究(REWIND)试验中,研究了胰高血糖素样肽 1 激动剂度拉鲁肽对有或无既往 HF 的患者的 HF 事件和其他心血管结局的影响。

方法和结果

REWIND 主要不良心血管事件(MACE)结局是首次发生非致命性心肌梗死、非致命性中风或心血管原因(包括原因不明)导致的死亡的复合终点。在这项事后分析中,HF 事件定义为经裁决确认的住院或 HF 的紧急评估。在中位随访 5.4 年的 9901 名研究参与者中,213/4949(4.3%)随机分配到度拉鲁肽组,226/4952(4.6%)参与者分配到安慰剂组发生 HF 事件(风险比[HR]0.93,95%置信区间[CI]0.77-1.12;p=0.456)。在基线时有 HF 的 853 名(8.6%)参与者中,与无 HF 的参与者相比,度拉鲁肽对 MACE 或 HF 事件均无变化(p=0.44 和 0.19,交互作用 p 值)。与安慰剂相比,度拉鲁肽联合心血管死亡和 HF 事件略有减少(HR 0.88,95%CI0.78-1.00;p=0.050),但在基线时有和无 HF 的患者中无变化(p=0.31)。

结论

在 5.4 年的随访中,无论基线 HF 状态如何,度拉鲁肽与 2 型糖尿病患者 HF 事件的减少无关。

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