Post Hoc analysis of EXAMINE trial for Nesina (alogliptin) showed no increased risk of heart failure risk- Takeda

Takeda Pharmaceutical Company Limited announced that a post hoc analysis of data 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 (CV) safety outcomes trial was published in The Lancet. An analysis of data from the study showed that in patients with Type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 inhibitor (DPP-4i) alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes. Alogliptin (n=201, 7.4%) compared with placebo (n=201, 7.5%) had no effect on the extended exploratory post hoc composite endpoint of CV death and hospitalized heart failure (HHF) (HR=1.00, 95% CI, 0.82, 1.21). Patients with a history of HF prior to randomization had a higher risk of HF outcomes in EXAMINE. The sub-analysis showed that the risk of the composite of CV death and HHF was not increased with alogliptin (n=107, 13.9%) compared with placebo (n=120, 15.7%) (HR=0.90, 95% CI, 0.70, 1.17). In patients without a history of HF at baseline, there was also no increased risk of the composite endpoint of CV death and HHF for alogliptin (HR=1.14 [95% CI 0.85-1.54], p=0.337) versus placebo, although there was in this sub group of patients a small absolute increase in HHF for alogliptin versus placebo (0.9%).

See- "Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial."- Prof Faiez Zannad, MD, et. al., for the EXAMINE Investigators -DOI: http://dx.doi.org/10.1016/S0140-6736(14)62225-X