利拉鲁肽,一种胰高血糖素样肽-1 类似物,对伴有或不伴有糖尿病的稳定慢性心力衰竭患者左心室功能的影响(LIVE)-一项多中心、双盲、随机、安慰剂对照试验。

Effect of liraglutide, a glucagon-like peptide-1 analogue, on left ventricular function in stable chronic heart failure patients with and without diabetes (LIVE)-a multicentre, double-blind, randomised, placebo-controlled trial.

机构信息

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.

出版信息

Eur J Heart Fail. 2017 Jan;19(1):69-77. doi: 10.1002/ejhf.657. Epub 2016 Oct 28.

Abstract

AIMS

To determine the effect of the glucagon-like peptide-1 analogue liraglutide on left ventricular function in chronic heart failure patients with and without type 2 diabetes.

METHODS AND RESULTS

LIVE was an investigator-initiated, randomised, double-blinded, placebo-controlled multicentre trial. Patients (n = 241) with reduced left ventricular ejection fraction (LVEF ≤45%) were recruited (February 2012 to August 2015). Patients were clinically stable and on optimal heart failure treatment. Intervention was liraglutide 1.8 mg once daily or matching placebo for 24 weeks. The LVEF was similar at baseline in the liraglutide and the placebo group (33.7 ± 7.6% vs. 35.4 ± 9.4%). Change in LVEF did not differ between the liraglutide and the placebo group; mean difference (95% confidence interval) was -0.8% (-2.1, 0.5; P = 0.24). Heart rate increased with liraglutide [mean difference: 7 b.p.m. (5, 9), P < 0.0001]. Serious cardiac events were seen in 12 (10%) patients treated with liraglutide compared with 3 (3%) patients in the placebo group (P = 0.04).

CONCLUSION

Liraglutide did not affect left ventricular systolic function compared with placebo in stable chronic heart failure patients with and without diabetes. Treatment with liraglutide was associated with an increase in heart rate and more serious cardiac adverse events, and this raises some concern with respect to the use of liraglutide in patients with chronic heart failure and reduced left ventricular function. More data on the safety of liraglutide in different subgroups of heart failure patients are needed.

摘要

目的

观察胰高血糖素样肽-1 类似物利拉鲁肽对合并或不合并 2 型糖尿病的慢性心力衰竭患者左心室功能的影响。

方法和结果

LIVE 是一项由研究者发起的、随机、双盲、安慰剂对照的多中心试验。入选(2012 年 2 月至 2015 年 8 月)了 241 名左心室射血分数(LVEF≤45%)降低的心力衰竭患者。患者临床稳定,且接受最佳心力衰竭治疗。干预措施为利拉鲁肽 1.8mg 每日 1 次或匹配安慰剂治疗 24 周。利拉鲁肽组和安慰剂组的 LVEF 基线相似(33.7±7.6%比 35.4±9.4%)。利拉鲁肽组和安慰剂组 LVEF 的变化无差异;平均差值(95%置信区间)为-0.8%(-2.1,0.5;P=0.24)。利拉鲁肽组心率增加[平均差值:7 次/分(5,9),P<0.0001]。与安慰剂组(3%)相比,利拉鲁肽组有 12(10%)例患者发生严重心脏不良事件(P=0.04)。

结论

与安慰剂相比,利拉鲁肽对合并或不合并糖尿病的稳定慢性心力衰竭患者的左心室收缩功能没有影响。利拉鲁肽治疗与心率增加和更多严重的心脏不良事件相关,这使得人们对利拉鲁肽在左心室收缩功能降低的慢性心力衰竭患者中的应用产生了一些担忧。需要更多关于利拉鲁肽在不同心力衰竭患者亚组中的安全性数据。

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