What Have We Learnt from Cardiovascular Outcome Studies of New Anti-diabetic Therapies in Last Decade?

Abstract

Diabetes has become a major health concern worldwide with a rapid increase in its prevalence rate. Cardiovascular complications are the leading cause of morbidity and mortality in diabetes. A 2007 meta-analysis of rosiglitazone showed significant increase in the risk of cardiovascular events with rosiglitazone therapy and that raised an alarm regarding cardiovascular safety of anti-diabetic drugs. Post this incidence in 2008, the UF FDA issued a guidance for the industry to conduct CVOT on new anti-diabetic therapies before they are approved for clinical use. Since then, all new anti-diabetic therapies underwent CVOTs for their cardiovascular safety evaluation. The objective of this paper is to review the key learnings from CVOTs of new anti-diabetic therapies published post 2008 FDA guidance.