Patients with type 2 diabetes (T2DM) and high cardiovascular (CV) risk due to recent acute coronary syndromes had similar rates of CV events when treated with the anti-diabetic agent alogliptin compared to placebo, according to results of the Examination of Cardiovascular Outcomes with Alogliptin vs Standard of Care (EXAMINE) trial presented at ESC, held in August-September in Amsterdam.
Designed as a non-inferiority trial, EXAMINE was undertaken to satisfy requirements that new diabetes drugs be subjected to studies to rule out CV risk. “Compared with placebo, treatment with alogliptin resulted in similar rates of the primary endpoint, which was a composite of cardiovascular death, myocardial infarction, and stroke,” said co-author William B. White, MD, of the University of Connecticut School of Medicine in Farmington, Connecticut. “The findings could guide clinicians to choose among the many anti-diabetic agents available when treating patients with type 2 diabetes and very high cardiovascular risk,” he suggested.
The researchers recruited 5380 patients from 898 centers in 49 countries and randomized them to receive alogliptin or placebo, administered in a double-blind fashion along with standard-of-care treatment for T2DM and CV risk factors. After a median follow-up of 18 months the primary endpoint (a composite of CV death, myocardial infarction, and stroke) had occurred at a similar rate in alogliptin and placebo-treated patients (11.3% vs 11.8% respectively; P <0.001 for non-inferiority).
As expected with an antihyperglycemic agent, end-of-study glycated hemoglobin levels were significantly lower in patients on alogliptin than placebo, with a mean change from baseline of -0.33% and +0.03% respectively.