Gantz I, et al. - This study analyzed the data from a terminated cardiovascular (CV) safety study designed to support the approval of omarigliptin in the United States. Findings showed that omarigliptin did not increase the risk of major adverse CV event (MACE) or hospitalization for heart failure (hHF) and was generally well tolerated among the patients with T2DM and established CV disease.

Methods

• This randomized, double-blind study included a total of 4202 patients with T2DM and established CV disease and assigned them to either omarigliptin 25 mg q.w. or matching placebo in addition to their existing diabetes therapy.
• A Cox proportional hazards model was used to summarize the primary endpoint of time to first major adverse CV event (MACE, the composite of CV death, nonfatal myocardial infarction, and nonfatal stroke) and the analysis of first event of hospitalization for heart failure (hHF).

Results

• Data reported that the median follow-up was approximately 96 weeks (range 1.1–178.6 weeks).
• Researchers found that the primary MACE outcome occurred in 114/2092 patients in the omarigliptin group (5.45%; 2.96/100 patient-years) and 114/2100 patients in the placebo group (5.43%; 2.97/100 patient-years), with a hazard ratio (HR) of 1.00 (95% confidence interval [CI] 0.77, 1.29).
• They also observed that the hHF outcome occurred in 20/2092 patients in the omarigliptin group (0.96%; 0.51/100 patient-years) and 33/2100 patients in the placebo group (1.57%; 0.85/100 patient-years), with an HR of 0.60 (95% CI 0.35, 1.05).
• Findings demonstrated that after 142 weeks, the least-squares mean difference (omarigliptin vs. placebo) in glycated hemoglobin levels was -0.3% (95% CI -0.46, -0.14).
• In addition, results reported that the numbers of patients with adverse events, serious adverse events or discontinued from study medication due to adverse events were similar in the omarigliptin and placebo groups.