Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis
Rossebø AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Bärwolf C, Holme I, Kesäniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R, SEAS Investigators
The New England journal of medicine · 1,154 citas
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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
- 2008-09-02 · N Engl J Med · vol. 359 · número 13 · págs. 1343–1356
- Editorial
- Massachusetts Medical Society
- Citado
- 1,642 citas · más que el 100% de estudios similares · 134.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 44 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cardiac Valve Diseases and Treatments · Blood Pressure and Hypertension Studies
- Palabras clave
- aortic stenosis, simvastatin, ezetimibe, intensive lipid lowering, hyperlipidemia, aortic valve replacement, ischemic cardiovascular events, coronary artery bypass grafting, cancer risk, statins, asymptomatic aortic stenosis, cardiovascular mortality, heart failure, stroke, myocardial infarction, unstable angina
- MeSH
- humans, neoplasms, cardiovascular diseases, aortic valve stenosis, disease progression, azetidines, simvastatin, alanine transaminase, aspartate aminotransferases, anticholesteremic agents, treatment outcome, drug therapy, combination, heart valve prosthesis implantation, coronary artery bypass, follow-up studies, double-blind method, adult, aged, aged, 80 and over, female, male, cholesterol, ldl, kaplan-meier estimate, ezetimibe
16 autores
- Anne Bjørhovde Rossebø
- Terje Rolf Pedersen🇳🇴University of Oslo
- Kurt Boman🇸🇪Umeå University
- Philippe Brudi🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- John Boyd Chambers
- Kenneth Egstrup🇩🇰Svendborg Sygehus
- Eva Gerdts🇳🇴Haukeland University Hospital; University of Bergen
- Christa Gohlke-Bärwolf🇩🇪Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Ingar Holme
- Yrjö Antero Kesäniemi🇫🇮University of Oulu
- William Malbecq🇧🇪MSD (Belgium)
- Christoph Anton Nienaber🇩🇪Universitätsmedizin Rostock
- Simon G Ray
- Terje Skjærpe🇳🇴St Olav's University Hospital
- Kristian Wachtell🇩🇰Rigshospitalet
- Ronnie B Willenheimer🇸🇪Lund University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Hyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results.
Methods
We conducted a randomized, double-blind trial involving 1873 patients with mild-to-moderate, asymptomatic aortic stenosis. The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. The primary outcome was a composite of major cardiovascular events, including death from cardiovascular causes, aortic-valve replacement, nonfatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary-artery bypass grafting, percutaneous coronary intervention, and nonhemorrhagic stroke. Secondary outcomes were events related to aortic-valve stenosis and ischemic cardiovascular events.
Results
During a median follow-up of 52.2 months, the primary outcome occurred in 333 patients (35.3%) in the simvastatin-ezetimibe group and in 355 patients (38.2%) in the placebo group (hazard ratio in the simvastatin-ezetimibe group, 0.96; 95% confidence interval [CI], 0.83 to 1.12; P=0.59). Aortic-valve replacement was performed in 267 patients (28.3%) in the simvastatin-ezetimibe group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P=0.97). Fewer patients had ischemic cardiovascular events in the simvastatin-ezetimibe group (148 patients) than in the placebo group (187 patients) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; P=0.02), mainly because of the smaller number of patients who underwent coronary-artery bypass grafting. Cancer occurred more frequently in the simvastatin-ezetimibe group (105 vs. 70, P=0.01).
Conclusions
Simvastatin and ezetimibe did not reduce the composite outcome of combined aortic-valve events and ischemic events in patients with aortic stenosis. Such therapy reduced the incidence of ischemic cardiovascular events but not events related to aortic-valve stenosis. (ClinicalTrials.gov number, NCT00092677.)
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