Draft FDA guidance for assessing the safety of glucose lowering therapies: a missed opportunity?

In 2008, the US Food and Drug Administration (FDA) issued guidance to the pharmaceutical industry to show the cardiovascular safety in new drug applications for treatments of type 2 diabetes. 1 Since then, a plethora of cardiovascular outcome trials have taken place, with some showing cardiovascular benefits, but also unexpected findings such as benefits for heart failure hospitalisation and renal outcomes. These trials have informed evidence-based guidelines and consensus recommendations that have substantially improved patient outcomes. However, these trials are fairly short and are event-driven studies recruiting high–risk populations who are unrepresentative of the general population who are prescribed these agents. [Taken from opening paragraph]