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达格列嗪可有效治疗心力衰竭和射血分数降低的患者
作者:小柯机器人 发布时间:2019/11/24 14:12:03

达格列嗪可有效治疗心力衰竭和射血分数降低的患者,这一成果由英国格拉斯哥大学John J.V. McMurray课题组取得。2019年11月21日,《新英格兰医学杂志》发表了这一最新研究成果。

在2型糖尿病患者中,钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂可能通过葡萄糖非依赖性机制来降低心力衰竭初次住院的风险。无论是否存在2型糖尿病,SGLT2抑制剂对心力衰竭和射血分数降低患者的作用仍有待研究。

在这项临床3期、安慰剂对照试验中,研究组招募了4744名纽约心脏病协会II-IV级心力衰竭患者。在常规治疗的基础上,将这些患者随机分组,2373例接受达格列嗪治疗,每日10mg;2371例接受安慰剂治疗。

中位随访18.2个月后,达格列嗪组中有386例(16.3%)患者发生心力衰竭恶化或心血管死亡,安慰剂组中有502例(21.2%),差异显著。达格列嗪组中有237名(10.0%)患者发生初次恶化的心力衰竭事件,安慰剂组有326名患者(13.7%)。达格列嗪组有276例(11.6%)患者发生全因死亡,安慰剂组有329例(13.9%)。糖尿病与非糖尿病患者之间上述各指标的差别均不大。两组间容量不足、肾功能不全和低血糖等不良事件的发生率亦无显著差异。

总之,对于心力衰竭和射血分数降低的患者,无论其是否存在糖尿病,达格列嗪治疗与安慰剂相比,可显著降低心力衰竭恶化或心血管死亡的风险。

附:英文原文

Title: Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

Author: John J.V. McMurray, M.D.,, Scott D. Solomon, M.D.,, Silvio E. Inzucchi, M.D.,, Lars Kber, M.D., D.M.Sc.,, Mikhail N. Kosiborod, M.D.,, Felipe A. Martinez, M.D.,, Piotr Ponikowski, M.D., Ph.D.,, Marc S. Sabatine, M.D., M.P.H.,, Inder S. Anand, M.D.,, Jan Bělohlávek, M.D., Ph.D.,, Michael Bhm, M.D., Ph.D.,, Chern-En Chiang, M.D., Ph.D.,, Vijay K. Chopra, M.D.,, Rudolf A. de Boer, M.D., Ph.D.,, Akshay S. Desai, M.D., M.P.H.,, Mirta Diez, M.D.,, Jaroslaw Drozdz, M.D., Ph.D.,, Andrej Dukát, M.D., Ph.D.,, Junbo Ge, M.D.,, Jonathan G. Howlett, M.D.,, Tzvetana Katova, M.D., Ph.D.,, Masafumi Kitakaze, M.D., Ph.D.,, Charlotta E.A. Ljungman, M.D., Ph.D.,, Béla Merkely, M.D., Ph.D.,, Jose C. Nicolau, M.D., Ph.D.,, Eileen O’Meara, M.D.,, Mark C. Petrie, M.B., Ch.B.,, Pham N. Vinh, M.D., Ph.D.,, Morten Schou, M.D., Ph.D.,, Sergey Tereshchenko, M.D., Ph.D.,, Subodh Verma, M.D., Ph.D.,, Claes Held, M.D., Ph.D.,, David L. DeMets, Ph.D.,, Kieran F. Docherty, M.B., Ch.B.,, Pardeep S. Jhund, M.B., Ch.B., Ph.D.,, Olof Bengtsson, Ph. Lic.,, Mikaela Sjstrand, M.D., Ph.D.,, and Anna-Maria Langkilde, M.D., Ph.D.

Issue&Volume:November 21, 2019

Abstract:

Background

In patients with type 2 diabetes, inhibitors of sodium–glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes.

Methods

In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death.

Results

Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups.

Conclusions

Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes.

DOI: 10.1056/NEJMoa1911303

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911303

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home