作者
Deepak L Bhatt, Michael Szarek, Bertram Pitt, Christopher P Cannon, Lawrence A Leiter, Darren K McGuire, Julia B Lewis, Matthew C Riddle, Silvio E Inzucchi, Mikhail N Kosiborod, David ZI Cherney, Jamie P Dwyer, Benjamin M Scirica, Clifford J Bailey, Rafael Díaz, Kausik K Ray, Jacob A Udell, Renato D Lopes, Pablo Lapuerta, P Gabriel Steg
发表日期
2021/1/14
期刊
New England Journal of Medicine
卷号
384
期号
2
页码范围
129-139
出版商
Massachusetts Medical Society
简介
Background
The efficacy and safety of sodium–glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied.
Methods
We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m2 of body-surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. The trial ended early owing to loss of funding.
Results
Of 19,188 patients screened, 10,584 were enrolled, with …
学术搜索中的文章
DL Bhatt, M Szarek, B Pitt, CP Cannon, LA Leiter… - New England Journal of Medicine, 2021