On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT).
Published
Journal Article
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.
Full Text
Duke Authors
Cited Authors
- Blazing, MA; Giugliano, RP; de Lemos, JA; Cannon, CP; Tonkin, A; Ballantyne, CM; Lewis, BS; Musliner, TA; Tershakovec, AM; Lokhnygina, Y; White, JA; Reist, C; McCagg, A; Braunwald, E
Published Date
- December 2016
Published In
Volume / Issue
- 182 /
Start / End Page
- 89 - 96
PubMed ID
- 27914504
Pubmed Central ID
- 27914504
Electronic International Standard Serial Number (EISSN)
- 1097-6744
Digital Object Identifier (DOI)
- 10.1016/j.ahj.2016.09.004
Language
- eng
Conference Location
- United States