Takeda announced results from the EXAMINE study on cardiovascular safety following treatment with alogliptin in addition to standard of care in patients with type 2 diabetes (T2DM) and recent acute coronary syndrome (ACS). The findings have been published in The Lancet.
In the randomized, double-blind, placebo-controlled outcomes study, EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) enrolled 5,380 patients in 49 countries with type 2 diabetes and an ACS within the previous 15–90 days. Patients were randomized to receive either alogliptin or placebo in addition to standard of care; in the alogliptin group, 71.4% of patients received 25mg, 25.7% received 12.5mg, and 2.9% received 6.25mg daily. Alogliptin doses were adjusted according to renal function and the median duration of exposure to the study drug was 533 days.
EXAMINE met its primary endpoint of non-inferiority compared to placebo, as no increase in cardiovascular risk was observed based on the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin and placebo groups (11.3% vs. 11.8% during a median follow-up period of 18 months, respectively). Mean change from baseline in HbA1c was -0.33% and 0.03% in the alogliptin and placebo arms, respectively, at the end of the study.
Alogliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as adjunct to diet and exercise to improve glycemic control in adults with T2DM.
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