Journal
AMERICAN HEART JOURNAL
Volume 168, Issue 2, Pages 205-+Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.ahj.2014.05.004
Keywords
-
Categories
Funding
- Merck
- Amgen
- Daiichi-Sankyo
- Accumetrics
- Arisaph
- AstraZeneca
- Boehringer-Ingelheim
- CSL Behring
- Essentialis
- GlaxoSmithKline
- Janssen
- Regeneron
- Sanofi
- Takeda
- Johnson Johnson
- Beckman-Coulter
- Roche Diagnostics
- Sanofi-Aventis
- Bristol-Myers Squibb
Ask authors/readers for more resources
Background The IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) is evaluating the potential benefit for reduction in major cardiovascular (CV) events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol (LDL-C) <= 125 mg/dL. Methods The primary composite end point is CV death, nonfatal myocardial infarction (MI), nonfatal stroke, rehospitalization for unstable angina (UA), and coronary revascularization (>= 30 days postrandomization). The simvastatin monotherapy arm's LDL-C target is <70 mg/dL. Ezetimibe was assumed to further lower LDL-C by 15 mg/dL and produce an estimated similar to 8% to 9% treatment effect. The targeted number of events is 5,250. Results We enrolled 18,144 patients with either ST-segment elevation MI (STEMI, n = 5,192) or UA/non-ST-segment elevation MI (UA/NSTEMI, n = 12,952) from October 2005 to July 2010. Western Europe (40%) and North America (38%) were the leading enrolling regions. The STEMI cohort was younger and had a higher percentage of patients naive to lipid-lowering treatment compared with the UA/NSTEMI cohort. The UA/NSTEMI group had a higher prevalence of diabetes, hypertension, and prior MI. Median LDL-C at entry was 100 mg/dL for STEMI and 93 mg/dL for UA/NSTEMI patients. Conclusions This trial is evaluating LDL-C lowering beyond previously targeted LDL-C levels. The results depend on achieving the desired separation of LDL-C with ezetimibe and on the assumption that ezetimibe's lowering of LDL-C will have similar event reduction efficacy as the LDL-C lowering from a statin. The results could affect future therapies and guidelines.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available