FDA panel to review 2008 guide on CV trials for diabetes drugs

FDA is reexamining its 2008 guidance recommending that manufacturers conduct trials to prove cardiovascular safety for all drugs intended to treat type 2 diabetes. The guidance was crafted following concerns about cardiovascular harm arising from older studies.

FDA is reexamining its 2008 guidance recommending that manufacturers conduct trials to prove cardiovascular safety for all drugs intended to treat type 2 diabetes. The guidance was crafted following concerns about cardiovascular harm arising from older studies. However, none of the eight clinical trials that have been conducted based on the guidance have identified excess cardiovascular risk from the drugs in question, and three have actually shown benefit. "Now that we have results of several trials and 10 years of experience with drug development under the guidance, it seems apropos to review what we have learned and consider what changes to the approach, if any, are necessary," according to FDA briefing documents. FDA's Endocrinologic and Metabolic Drugs Advisory Committee is voting on "whether an unacceptable increase in cardiovascular risk needs to be excluded for all new drugs to improve glycemic control in patients with type 2 diabetes, regardless of the presence or absence of a signal for cardiovascular risk in the development program." It is also examining the guidance's impact on drug assessment, the inclusion of high-risk patients in order to achieve statistically significant numbers of endpoints, and how the cardiovascular safety findings for one drug should or should not be applied to other medications in the same class.