We have selected EXAMINE because is one of the largest triasl analizing cardiovascular outcomes and safety with a new group of antidiabetic drugs. The main results showed the primary endpoint of non-inferiority compared to placebo in addition to standard of care was met with no increase in CV risk in a Type 2 diabetes patient population at high-risk for CV events. This data, published in the New England Journal of Medicine (NEJM) and also presented at the ESC Congress 2013, demonstrates that alogliptin does not increase CV risk in Type 2 diabetes patients at high-risk for major adverse cardiac events (MACE) due to a recent acute coronary syndrome (ACS). The trial’s primary objective was to evaluate non-inferiority of CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin and placebo groups (in 11.3% of patients vs. 11.8% of patients during a median follow-up period of 18 months; hazard ratio, 0.96; one sided repeated confidence interval [CI] bound, 1.16). Alogliptin is a dipeptidyl peptidase-4 inhibitor (DPP-4i) for the treatment of Type 2 diabetes in adults to improve glycemic control as an adjunct to diet and exercise.
“There is a need for safer glucose lowering therapies in patients with diabetes who are at an elevated risk for cardiovascular disease,” stated William B. White, MD, FASH, FAHA, FACP, principal investigator of the EXAMINE trial. “Given the EXAMINE study design and high-risk patient population evaluated, these results provide key insights to clinicians treating diabetes patients with coronary disease.”
The global EXAMINE trial is an important evaluation as it assesses CV safety in patients known to be at an elevated risk of cardiovascular disease (CVD), the leading cause of morbidity and mortality in the Type 2 diabetes patient population. A global, large, randomized, double-blind, placebo-controlled clinical trial, EXAMINE was designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care alone, in patients with Type 2 diabetes and a recent ACS.
During the EXAMINE trial, patients were randomly assigned to receive alogliptin or placebo in addition to standard of care medications for diabetes and CVD. A total of 5,380 patients were randomly assigned and followed for a median of 18 months and up to 40 months. The rate of premature discontinuation of the study drug was similar in the alogliptin and placebo groups. Patients also received high levels of standard of care for treatment of Type 2 diabetes and CV risk factors.
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