On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)

Michael A. Blazing, Robert P. Giugliano, James A de Lemos, Christopher P. Cannon, Andrew Tonkin, Christie M. Ballantyne, Basil S. Lewis, Thomas A. Musliner, Andrew M. Tershakovec, Yuliya Lokhnygina, Jennifer A. White, Craig Reist, Amy McCagg, Eugene Braunwald

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

Background We aimed to determine the efficacy and safety of adding ezetimibe (Ez) to simvastatin (S) in a post–acute coronary syndrome (ACS) population in a prespecified on-treatment analysis. Methods We evaluated 17,706 post-ACS patients from the IMPROVE-IT trial who had low-density lipoprotein cholesterol values between 50 and 125 mg/dL and who received Ez 10 mg/d with S 40 mg/d (Ez/S) or placebo with simvastatin 40 mg/d (P/S). The primary composite end point was cardiovascular death, myocardial infarction, unstable angina, coronary revascularization ≥30 days postrandomization, or stroke. The on-treatment analysis included patients who received study drug for the duration of the trial or experienced a primary end point or noncardiovascular death within 30 days of drug discontinuation. Results Mean low-density lipoprotein cholesterol values at 1 year were 71 mg/dL for P/S and 54 mg/dL for Ez/S (absolute difference −17 mg/dL = −24%; P <.001). The 7-year Kaplan-Meier estimate of the primary end point occurred in 32.4% in the P/S arm and 29.8% in the Ez/S arm (absolute difference 2.6%; HRadj 0.92 [95% CI 0.87-0.98]; P =.01). The absolute treatment effect favoring Ez/S was 30% greater than in the intention-to-treat analysis of IMPROVE-IT. Conclusions This analysis provides additional support for the efficacy and safety of adding Ez to S in this high-risk, post-ACS population.

Original languageEnglish (US)
Pages (from-to)89-96
Number of pages8
JournalAmerican heart journal
Volume182
DOIs
StatePublished - Dec 1 2016

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)'. Together they form a unique fingerprint.

  • Cite this

    Blazing, M. A., Giugliano, R. P., de Lemos, J. A., Cannon, C. P., Tonkin, A., Ballantyne, C. M., Lewis, B. S., Musliner, T. A., Tershakovec, A. M., Lokhnygina, Y., White, J. A., Reist, C., McCagg, A., & Braunwald, E. (2016). On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT). American heart journal, 182, 89-96. https://doi.org/10.1016/j.ahj.2016.09.004