Current perspectives on cardiovascular outcome trials in diabetes

Oliver Schnell, Lars Rydén, Eberhard Standl, Antonio Ceriello, on behalf of the D&CVD EASD Study Group

Research output: Contribution to journalReview article

Abstract

Cardiovascular disease (CVD) is one of the most common diabetes-associated complications, as well as a leading cause for death in type 2 diabetes patients (T2D). Despite the well-known correlation between the two, up until the 2008 FDA industry guidance for licensing of new anti-hyperglycemic drugs, which required an investigation of cardiovascular outcomes (CVO) of glucose-lowering agents, only a few studies had looked into the relationship between glucose lowering drugs and cardiovascular (CV) risk. Thereafter, CVOT design has focused on non-inferiority short-term studies on high-risk patient populations aiming at capturing CV safety issues. Despite the wealth of information and useful data provided by CVOTs, this approach still suffers from certain limitations. The present review will condense the main results of the most recently completed CVOTs, reflect on the lessons learned, discuss on the issues presented by current CVOT design and offer some suggestions for improvement.

Original languageEnglish
Article number139
JournalCardiovascular Diabetology
Volume15
Issue number1
DOIs
Publication statusPublished - Oct 1 2016

Keywords

  • Cardiovascular risk
  • Cardiovascular safety
  • CVOT
  • Diabetes
  • Non-inferiority

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Cardiology and Cardiovascular Medicine

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    Schnell, O., Rydén, L., Standl, E., Ceriello, A., & on behalf of the D&CVD EASD Study Group (2016). Current perspectives on cardiovascular outcome trials in diabetes. Cardiovascular Diabetology, 15(1), [139]. https://doi.org/10.1186/s12933-016-0456-8