Evaluating cardiovascular event reduction with ezetimibe as an adjunct to simvastatin in 18,144 patients after acute coronary syndromes: Final baseline characteristics of the IMPROVE-IT study population - 25/07/14
, Robert P. Giugliano, MD, SM b, Christopher P. Cannon, MD b, Thomas A. Musliner, MD c, Andrew M. Tershakovec, MD, MPH c, Jennifer A. White, MS a, Craig Reist, PhD a, Amy McCagg, BS b, Eugene Braunwald, MD b, Robert M. Califf, MD aRésumé |
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 ~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.
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| Roger S. Blumenthal, MD, served as guest editor for this article. |
Vol 168 - N° 2
P. 205 - août 2014 Retour au numéro
Article précédent
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