CV data published for DPP-4 inhibitors Nesina, Onglyza

The New England Journal of Medicine published data from cardiovascular outcomes trials for diabetes drugs Nesina alogliptin from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Onglyza saxagliptin from Bristol-Myers Squibb Co. (NYSE:BMY) and partner AstraZeneca plc (LSE:AZN; NYSE:AZN). The data for the oral dipeptidyl peptidase-4 (DPP-4) inhibitors were also presented at the European Society of Cardiology meeting in Amsterdam.

In the Phase III EXAMINE trial, Takeda's once-daily Nesina 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 myocardial infarction (MI) or non-fatal stroke at a median follow-up of 18 months (11.3% vs. 11.8%, p<0.001 for non-inferiority). The trial enrolled 5,380 Type II diabetics who had either an acute MI or unstable angina requiring hospitalization. FDA, which approved Nesina in January, asked Takeda to conduct an additional cardiovascular study for alogliptin in a 2009 complete response letter. Interim data from the trial were included in the NDA that FDA approved. ...