This randomized, double-blind, placebo-controlled, multicenter work evaluated the potential cardiovascular reduction risk and the long-term safety profile of Aleglitazar, compared with placebo in patients with type 2 diabetes experiencing an acute coronary syndrome. A total of 7226 patients were randomized at 12 weeks post-acute coronary event to receive Aleglitazar 150 ug or placebo. The study was prematurely discontinued for lack of efficacy in addition to safety concerns for increased risk of heart failure, renal failure, bone fractures, gastrointestinal bleeding and hypoglycemia. No differences in the primary end point of cardiovascular mortality, nonfatal myocardial infarction and stroke were observed.
Conclusion
Aleglitazar added to standard therapy in patients with type 2 diabetes who recently suffered an acute coronary syndrome reduces glycated hemoglobin, improves triglycerides and HDL but does not change the risk of cardiovascular death, heart attack or stroke in addition to an increased risk of hospitalization for heart failure, renal failure, bone fractures, gastrointestinal bleeding and hypoglycemia.
A. Michael Lincoff
2014-03-31
Original title: Evaluation of the Dual PPAR-α/γ Agonist Aleglitazar to Reduce Cardiovascular Events in Patients with Acute Coronary Syndrome and Type 2 Diabetes Mellitus: the AleCardio Trial.
