The ongoing European Society of Cardiology meeting in Amsterdam, Netherlands, continues to produce both positive and negative clinical trials results (see also recent stories by The Pharma Letter).
Among the latest news coming from this meeting, Japan’s largest drugmaker Takeda Pharmaceuticals (TYO: 4502) announced results of the EXAMINE trial (n=5,380) showing that alogliptin met the primary endpoint of non-inferiority compared to placebo in addition to standard of care with no increase in cardiovascular (CV) risk in diabetes patients at high-risk for major adverse cardiac events (MACE) due to a recent acute coronary syndrome (ACS).
In the study, the primary endpoint occurred at similar rates in the alogliptin and placebo groups (11.3% versus 11.8%, respectively, during a median follow-up period of 18 months; HR 0.96; one-sided repeated confidence interval [CI] bound, 1.16). The principal secondary safety endpoint of CV death, myocardial infarction, stroke and unstable angina with urgent revascularization showed no difference in rates on alogliptin versus placebo (12.7% vs. 13.4%; hazard ratio, 0.95; one-sided repeated CI bound, 1.14).
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