Takeda to present additional data from EXAMINE trial


Takeda Pharmaceutical Company will present sub-analyses from the global EXAMINE (Examination of cardiovascular outcomes: alogliptin vs standard of care in Patients with type 2 diabetes mellitus and acute coronary syndrome) cardiovascular safety outcomes trial in a poster session at the American College of Cardiology’s (ACC) 63rd Annual Scientific Session in Washington, DC. These sub-analyses specifically investigated the effects of the dipeptidyl peptidase-4 inhibitor (DPP-4i) alogliptin on rates of cardiovascular mortality and hospitalisation for heart failure.

Alogliptin is the first and only DPP-4i to demonstrate cardiovascular safety outcomes in type 2 diabetes patients with recent acute coronary syndrome. Heart disease, or cardiovascular disease, is the leading cause of morbidity and mortality in patients with type 2 diabetes, and is responsible for between 50 and 80% of deaths in people with diabetes.


Findings from the sub-analysis, “Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndrome from the EXAMINE Trial”, demonstrated no effect on rates of cardiovascular mortality [hazard ratio (HR)=0.85, 95% confidence interval (CI): 0.66, 1.10] in patients with type 2 diabetes and recent acute coronary syndrome with alogliptin, compared to placebo (n=112, 4.1% and n=130, 4.9%, respectively). There was also no increase in sudden cardiac death with alogliptin (n=59, 2.2%) versus placebo (n=73, 2.7%) [HR=0.80, 95% CI: 0.57, 1.12].


The other sub-analysis, “Alogliptin in patients with type 2 diabetes after acute coronary syndromes: Heart failure outcomes and cardiovascular safety in heart failure patients”, demonstrated that in patients with type 2 diabetes and recent acute coronary syndrome, the pre-specified composite cardiovascular outcome of first occurrence of all-cause mortality, nonfatal MI and stroke, urgent revascularisation due to unstable angina, and hospitalisation for heart failure was similar for alogliptin compared with placebo [HR=0.98, 95% CI, 0.86-1.12]. Within this composite endpoint, hospitalised heart failure occurred in 3.1% of patients on alogliptin versus 2.9% on placebo [HR=1.07, 95% CI, 0.79-1.46]. Additionally, alogliptin neither induced new onset heart failure nor worsened heart failure outcomes in patients with a history of heart failure and / or with markers for heart failure (elevated NT-pro-BNP levels).


“Cardiovascular events are very common in patients with type 2 diabetes, so it is important that diabetes treatments adequately manage glucose levels in these patients without adversely affecting cardiovascular outcomes, such as hospitalised heart failure and cardiac death,” says William B White, principal investigator of the EXAMINE trial and abstract author. “Based on data presented, alogliptin showed no difference from placebo on rates of cardiovascular mortality and hospitalised heart failure in this high risk population of patients with type 2 diabetes.”