Nesina alogliptin: Phase III data

The double-blind, international Phase III EXAMINE cardiovascular outcomes trial in 5,380 Type II diabetics with acute coronary syndrome (ACS) showed that once-daily oral alogliptin in combination with patients' existing anti-hyperglycemic and cardiovascular therapy met the primary endpoint of non-inferiority to placebo plus existing therapy in the incidence of the composite of CV death, non-fatal MI or non-fatal stroke at a median follow-up of 18 months. Specifically, the primary composite endpoint occurred in 11.3% (n=305) of patients receiving alogliptin vs. 11.8% (n=316) of patients receiving placebo (HR=0.96, p<0.001 for non-inferiority). The pre-specified non-inferiority margin was a hazard ratio of 1.3. Alogliptin was not superior to placebo on the composite primary endpoint (p=0.32 for superiority).

Alogliptin was also non-inferior to placebo on the secondary composite endpoint of the incidence of CV death, non-fatal MI, non-fatal stroke or urgent revascularization due to unstable angina (12.7% vs. 13.4%, HR=0.95). Additionally, hazard ratios for death from any cause and CV death were consistent with the hazard ratio for the primary composite endpoint. Alogliptin also significantly reduced mean HbA1c from baseline to the end of treatment by 0.33% vs. an increase of 0.3% for placebo (p<0.001). There were no significant differences between treatment groups in the incidences of serious adverse events, angioedema and cancer, with no cases of pancreatic cancer reported. The incidences of hypoglycemia and pancreatitis were also similar between groups. The trial enrolled Type II diabetics who had either an acute MI or unstable angina requiring hospitalization within the previous 15-90 days. Data were published in the New England Journal of Medicine and presented at the European Society of Cardiology meeting in Amsterdam. ...