CV Risks With Alogliptin in Type 2 Diabetes and Recent Acute Coronary Syndrome
Investigators note that alogliptin did not increase or decrease the risk for initial or recurrent cardiovascular events in patients with type 2 diabetes.
Alogliptin is not associated with an increased risk for adverse cardiovascular (CV) events in individuals with type 2 diabetes mellitus and a recent acute coronary syndrome (ACS), according to a study recently published in Clinical Cardiology.
Researchers included 5380 patients from the Examination of Cardiovascular Outcomes with Alogliptin vs Standard of Care (EXAMINE) trial. This was a double-blind, randomized controlled trial investigating the time to first major CV event of alogliptin in individuals with type 2 diabetes who had recently experienced an ACS. Over the 1.5-year follow-up period, 720 patients (13.4%) experienced 1 CV event and 380 (7.1%) experienced at least 2 CV events. Each individual in the group with recurrent CV events experienced a mean of 1.6 (standard deviation 1.2) CV events in the follow-up period. The patients in this group were also older, were likelier to have renal disease, had a longer history of type 2 diabetes, and showed more history of peripheral arterial disease, heart failure, and/or previous stroke.
Of the 2701 subjects who received alogliptin, 545 first incidences of CV event and 328 further CV events occurred. In the placebo group of 2679, there were 555 first incidences and 338 further events. The difference between these groups was not significant (P =.52) in terms of type or number of CV events.
Alogliptin has been approved for use in treating individuals with type 2 diabetes, and its effects on CV health were demonstrated via the EXAMINE trial. However, the time to either CV death or non-fatal myocardial infarction or stroke was the primary outcome of the EXAMINE trial, whereas this study investigated a more comprehensive outcome of these occurrences.
The study researchers conclude that “[alogliptin] did not increase the risk of either first or recurrent CV events when compared to placebo in patients with type 2 diabetes and recent ACS. These data support the CV safety of alogliptin in patients who are at increased risk of future CV events.”
Cavender MA, White WB, Liu Y, et al. Total cardiovascular events analysis of the EXAMINE trial in patients with type 2 diabetes and recent acute coronary syndrome[published online April 13, 2018]. Clin Cardiol. doi: 10.1111/clc.22960