Impact of Ezetimibe on New‐Onset Diabetes: A Substudy of IMPROVE‐IT
Nishant Shah, Darren K. McGuire, Christopher P. Cannon, Robert P. Giugliano, Yuliya Lokhnygina, Courtney Page, Andrew M. Tershakovec, Eugene Braunwald, Michael A. Blazing
Abstract
tatins have been associated with an increased risk for new-onset diabetes (NOD). 1 However, it is unclear if the addition of the nonstatin therapy ezetimibe to a statin would affect the incidence of NOD. We therefore evaluated the risk of NOD with ezetimibe added to simvastatin versus placebo added to simvastatin in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). Because glycosylated hemoglobin was not measured systematically during the trial, NOD was defined for the primary analysis as either the initiation of an antihyperglycemic medication or 2 consecutive blood glucose measurements of 126 mg/dL and was analyzed as time-to-event outcome. Sensitivity analyses using other potential indicators to define NOD were also performed (Table ). To account for interval censored data due to medications and blood glucose recorded only at the study visits, parametric Weibull regression univariable and multivariable models were used to determine predictors of NOD.