On-Treatment Analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)
Journal Title: | The American heart journal 2016, Vol.182, p.89-96 |
Main Author: | Blazing, Michael A., MD |
Other Authors: | Giugliano, Robert P., MD, SM , de Lemos, James A., MD , Cannon, Christopher P., MD , Tonkin, Andrew, MBBS, MD , Ballantyne, Christie M., MD , Lewis, Basil S., MD , Musliner, Thomas A., MD , Tershakovec, Andrew M., MD, MPH , Lokhnygina, Yuliya, PhD , White, Jennifer A., MS , Reist, Craig, PhD , McCagg, Amy, BS , Braunwald, Eugene, MD |
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Quelle: | Alma/SFX Local Collection |
Publisher: | United States: Elsevier Inc |
ID: | ISSN: 0002-8703 |
Link: | https://www.ncbi.nlm.nih.gov/pubmed/27914504 |
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recordid: | cdi_proquest_miscellaneous_1868340905 |
title: | On-Treatment Analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) |
format: | Article |
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ispartof: | The American heart journal, 2016, Vol.182, p.89-96 |
description: | 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 (LDL-C) values between 50 and 125 mg/dL and who received Ez 10 mg/day with S 40 mg/day (Ez/S) or placebo with simvastatin 40 mg/day (P/S). The primary composite endpoint was cardiovascular death, myocardial infarction, unstable angina, coronary revascularization ≥30 days post randomization, or stroke. The on-treatment analysis included patients who received study drug for the duration of the trial or experienced a primary endpoint or non-cardiovascular death within 30 days of drug discontinuation. Results Mean LDL-C 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 endpoint 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. |
language: | eng |
source: | Alma/SFX Local Collection |
identifier: | ISSN: 0002-8703 |
fulltext: | fulltext |
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url: | Link |
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