Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes.

Conclusions: EXSCEL-observed HRs for MACE and ACM remained robust after right censoring or application of literature-derived risk reductions, but the exenatide versus placebo MACE effect size and statistical significance were increased by IPTW. Effects of open-label drop-in cardioprotective medications need to be considered carefully when designing, conducting, and analyzing cardiovascular outcome trials of glucose-lowering agents under the premise of glycemic equipoise. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01144338.
PMID: 32098501 [PubMed - as supplied by publisher]

Source: Circulation - February 25, 2020 Category: Cardiology Authors: Bethel MA, Stevens SR, Buse JB, Choi J, Gustavson SM, Iqbal N, Lokhnygina Y, Mentz RJ, Patel RA, Öhman P, Schernthaner G, Lecube A, Hernandez AF, Holman RR Tags: Circulation Source Type: research