Cardiovascular outcome trials in type 2 diabetes – 2015

In December 2008 the US Food and Drug Administration (FDA) required that new drug applications for glucose-lowering agents must include a meta-analysis of all cardiovascular (CV) events during phase 2 and 3 trials (FDA, 2008). The level of relative risk would then be used to determine the need, or otherwise, for post-marketing studies (Table 1). This action was spurred by controversy about rosiglitazone, which raised the possibility that an anti-diabetic drug might exacerbate CV risk in people with type 2 diabetes. Thus the so-called CV outcome (or safety) trials were born. Although these safety trials are a “must do” if …