Assessment of Heart Failure in Diabetes Cardiovascular Outcomes Trials: Is What We Are Currently Capturing Adequate?

Abstract

Purpose of review: Since the 2008 FDA guidance restructuring the design of trials for the approval of novel glucose-lowering agents, 13 medications have now been evaluated by dedicated cardiovascular outcome trials. All of the completed trials have included data (though with varying definitions) on rates of hospitalization for heart failure. This review is aimed at summarizing current heart failure outcome data available from cardiovascular safety trials for novel glucose-lowering agents in patients with type 2 diabetes mellitus.

Recent findings: There appears to be growing evidence for the benefit of sodium-glucose cotransporter-2 inhibitors, and there are still not enough data to fully support the safety of glucagon-like peptide 1 receptor agonists in heart failure. Increased rates of hospitalization for heart failure were seen with both saxagliptin and alogliptin, and this has led to a class warning for all dipeptidyl peptidase-4 inhibitors. Future studies should have a standardized definition of "hospitalization for heart failure," should consider including hospitalization for heart failure as a component of the primary composite endpoint, and should provide a more detailed description of the baseline characteristics of enrolled study participants with heart failure.

Keywords: Cardiovascular outcomes; Diabetes mellitus; Heart failure.