Cardiovascular outcome trials in type 2 diabetes: what have we learned from the past and present?

Abstract

There is a wealth of epidemiological data which shows that type 2 diabetes significantly increase the risk of cardiovascular events. The evidence from earlier trials have demonstrated that improvement in glycated haemoglobin will reduce the risk of micro vascular disease but there is lack of robust evidence to suggest whether improvement in glycaemic control will have similar beneficial outcomes on macro vascular disease. In the last few years there have been a paradigm shift by which cardiovascular trials relating to therapy in type 2 diabetes are being conducted as every new drug needs to demonstrate cardiovascular safety as per the requirements set by several health regulatory authorities. This has led to alteration in study designs, duration for which they are conducted and end points which are being assessed. As a result, the intended risks and benefits relating to these newer agents are insufficiently explored which may have potential implications in long term management of a chronic disease like type 2 diabetes. This article provides a comparison between past and present cardiovascular outcome trials focussing mainly on oral agents used in type 2 diabetes and also explores the challenges encountered in conducting such trials.