CVOT crossroads

As data begin to trickle in from the wave of cardiovascular outcomes trials mandated in the wake of the Avandia rosiglitazone debacle, patients, physicians and some of FDA's own advisory committee members think the agency should either scrap the requirement for outcomes studies, or refocus them on issues that matter to patients and physicians.

On April 14, FDA's Endocrinologic and Metabolic Drugs Advisory Committee met to discuss results from the SAVOR and EXAMINE cardiovascular outcomes trials of the DPP-4 inhibitors Onglyza saxagliptin from AstraZeneca plc and Nesina alogliptin from Takeda Pharmaceutical Co. Ltd...