Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes
Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM, IMPROVE-IT Investigators
The New England journal of medicine · 3,159 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2015-06-04 · N Engl J Med · vol. 372 · número 25 · págs. 2387–2397
- Editorial
- Massachusetts Medical Society
- Citado
- 4,486 citas · más que el 100% de estudios similares · 465.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 43 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cholesterol and Lipid Metabolism · Acute Myocardial Infarction Research
- Palabras clave
- ezetimibe, simvastatin, statin therapy, acute coronary syndrome, LDL cholesterol lowering, cardiovascular events, lipid-lowering therapy, combination therapy, cardiovascular mortality, myocardial infarction, LDL cholesterol targets, cholesterol absorption inhibition, adverse drug reactions, cancer risk, gallbladder disease, hepatic adverse effects, coronary revascularization, stroke
- MeSH
- humans, cardiovascular diseases, azetidines, simvastatin, triglycerides, anticholesteremic agents, hydroxymethylglutaryl-coa reductase inhibitors, drug therapy, combination, double-blind method, aged, middle aged, female, male, cholesterol, ldl, acute coronary syndrome, kaplan-meier estimate, ezetimibe
21 autores
- Christopher Paul Cannon🇺🇸🇮🇹🇳🇱🇨🇦Brigham and Women's Hospital; Harvard University; University of Pavia; Leiden University Medical Center; Montreal Heart Institute; Thrombolysis in Myocardial Infarction Study Group
- Michael A. Blazing🇺🇸Brigham and Women's Hospital; Harvard University
- Robert Patrick Giugliano🇺🇸Brigham and Women's Hospital; Harvard University
- Amy McCagg🇺🇸Brigham and Women's Hospital; Harvard University
- Jennifer A. White🇺🇸Brigham and Women's Hospital; Harvard University
- Pierre Théroux🇺🇸🇨🇦Brigham and Women's Hospital; Harvard University; Montreal Heart Institute
- Harald Darius🇺🇸🇩🇪Brigham and Women's Hospital; Harvard University; Vivantes Klinikum
- Basil S. Lewis🇺🇸🇮🇱Brigham and Women's Hospital; Harvard University; Carmel Medical Center
- Ton Oude Ophuis🇳🇱Canisius-Wilhelmina Ziekenhuis
- J. Wouter Jukema🇺🇸🇳🇱Brigham and Women's Hospital; Harvard University; Leiden University Medical Center
- Gaetano Maria De Ferrari🇺🇸🇮🇹Brigham and Women's Hospital; Harvard University; University of Pavia; Policlinico San Matteo Fondazione
- Witold Rużyłło🇵🇱Institute of Cardiology
- Paul De Lucca🇺🇸Brigham and Women's Hospital; Merck & Co., Inc., Rahway, NJ, USA (United States); Harvard University
- KyungAh Im🇺🇸Brigham and Women's Hospital; Harvard University
- Erin Ann Bohula🇺🇸Brigham and Women's Hospital; Harvard University
- Craig Reist🇺🇸Brigham and Women's Hospital; Harvard University
- Stephen D. Wiviott🇺🇸Brigham and Women's Hospital; Harvard University
- Andrew M. Tershakovec🇺🇸Brigham and Women's Hospital; Merck & Co., Inc., Rahway, NJ, USA (United States); Harvard University
- Thomas A. Musliner🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Eugene Braunwald M. D🇺🇸Brigham and Women's Hospital; Harvard University
- Robert M. Califf🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known.
Methods
We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years.
Results
The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P=0.016). Rates of prespecified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups.
Conclusions
When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.