Are There Alternative Strategies to the Current Practice of Large Cardiovascular Outcome Trials for Assessing CV Risk of Products for Type 2 Diabetes?

• Activity Number: 399
• Type: Invited
• Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
• Sponsor: ENAR
• Author(s): Christy Chuang-Stein*
• Companies: Pfizer Inc.
• Keywords: Cardiovascular outcome trial ; Major adverse cardiovascular endpoint ; Safety Working Group ; Type 2 diabetes

Abstract

In 2008, US FDA issued a guidance on evaluating CV risk in new therapies for type 2 diabetes (T2DM). The guidance states that if the premarketing clinical data could rule out a relative risk > 1.8 on a major adverse CV endpoint (MACE) and the overall risk-benefit analysis is favorable, the product could be approved, conditioning on the sponsor demonstrating post-marketing that a relative risk > 1.3 could also be ruled out. Post-marketing evidence could come from a new CV outcome trial (CVOT) or additional data in a CVOT that was ongoing at the time of the application. The guidance notes that a post-marketing CVOT may not be necessary if the premarketing application could rule out a relative risk > 1.3. So far, all products approved for T2DM since 2008 were evaluated in CVOTs and the 1.3 requirement was met in all cases where the CVOTs were completed. It is natural to ask whether there are important lessons from these CVOTs and if these lessons can help us develop innovative approaches to more effectively assess the CV risk. In this presentation, we will share work of a statistical Safety Working Group on this question, hoping to stimulate additional research by other on this topic.