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Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial.

Abstract：

BACKGROUND:Peroxisome proliferator-activated receptors (PPARs) regulate transcription of genes involved in glucose uptake, lipid metabolism, and inflammation. Aleglitazar is a potent dual PPAR agonist with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles and biomarkers of cardiovascular risk. The AleCardio trial examines whether the addition of aleglitazar to standard medical therapy reduces the risk of cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and recent acute coronary syndrome. STUDY DESIGN:AleCardio is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. A total of 7,228 patients were randomized to aleglitazar 150 μg or placebo daily in addition to standard medical therapy. The primary efficacy end point is time to the first event of cardiovascular death, myocardial infarction, or stroke. Principal safety end points are hospitalization due to heart failure and changes in renal function. Treatment will continue until 7,000 patients are followed up for at least 2.5 years and 950 primary end point events are adjudicated. CONCLUSIONS:AleCardio will establish whether the PPAR-α/γ agonist aleglitazar improves cardiovascular outcomes in patients with diabetes and high-risk coronary disease.

journal_name

Am Heart J

journal_title

American heart journal

authors

Lincoff AM,Tardif JC,Neal B,Nicholls SJ,Rydén L,Schwartz GG,Malmberg K,Buse JB,Henry RR,Wedel H,Weichert A,Cannata R,Grobbee DE

doi

10.1016/j.ahj.2013.05.013

subject

Has Abstract

pub_date

2013-09-01 00:00:00

pages

429-34

issue

3

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(13)00361-X

journal_volume

166

pub_type

杂志文章,多中心研究,随机对照试验

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