Analyses of cancer data from three ezetimibe trials
Peto R, Emberson J, Landray M, Baigent C, Collins R, Clare R, Califf R
The New England journal of medicine · 149 citas
Cómo se estudió
- Diseño
- Metaanálisis (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Medical Research Council
Según 1 financiador declarado.
Publicación
- Publicado
- 2008-09-03 · N Engl J Med · vol. 359 · número 13 · págs. 1357–1366
- Editorial
- Massachusetts Medical Society
- Citado
- 228 citas · más que el 100% de estudios similares · 38.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 26 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cancer, Lipids, and Metabolism · Cholesterol and Lipid Metabolism
- Palabras clave
- ezetimibe, cancer incidence, cancer mortality, statin therapy, simvastatin, LDL cholesterol lowering, SEAS trial, SHARP trial, IMPROVE-IT trial, cardiovascular drug safety, aortic stenosis, tumor site distribution
- MeSH
- humans, neoplasms, aortic valve stenosis, hypercholesterolemia, azetidines, simvastatin, anticholesteremic agents, drug therapy, combination, incidence, risk, follow-up studies, cholesterol, ldl, randomized controlled trials as topic, ezetimibe
7 autores
- Richard Peto🇬🇧University of Oxford
- Jonathan Emberson🇬🇧University of Oxford
- Martin Landray🇬🇧University of Oxford
- Colin Baigent🇬🇧University of Oxford
- Rory Collins🇬🇧University of Oxford
- Robert M. Clare🇺🇸Duke University
- Robert M. Califf🇺🇸Duke University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Five years of statin therapy lowers low-density lipoprotein (LDL) cholesterol substantially and, over a 5-year period, results in reductions in the incidence of cardiovascular events. The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial (ClinicalTrials.gov number, NCT00092677) has raised the hypothesis that adding ezetimibe to statin therapy for larger LDL cholesterol reductions might increase the incidence of cancer.
Methods
We compared the results of a hypothesis-generating analysis of the incidence of cancer in the SEAS trial of ezetimibe plus simvastatin in 1873 patients (mean follow-up after ezetimibe or matching placebo was begun, 4.1 years) with a hypothesis-testing analysis of cancer data from the two large ongoing trials of this regimen: the Study of Heart and Renal Protection (SHARP) (NCT00125593) with 9264 patients (mean follow-up, 2.7 years) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) (NCT00202878), currently with 11,353 patients (mean follow-up, 1.0 year).
Results
In the SEAS trial, assignment to ezetimibe was associated with an increase in any new onset of cancer (101 patients in the active-treatment group vs. 65 in the control group) from several cancer sites. In SHARP and IMPROVE-IT combined, there was no overall excess of cancer (313 active-treatment vs. 326 control; risk ratio, 0.96; 95% confidence interval, 0.82 to 1.12; P=0.61) and no significant excess at any particular site. Among patients assigned to ezetimibe, there were more, albeit not significantly more, deaths from cancer (97, vs. 72 in the control group; P=0.07), but there were also fewer, although not significantly fewer, other cases of cancer (216, vs. 254 in the control group; P=0.08). There was no evidence of a trend in the risk ratio for incidence of or death from cancer with increasing duration of follow-up.
Conclusions
The available results from these three trials do not provide credible evidence of any adverse effect of ezetimibe on rates of cancer. Follow-up of longer duration will permit the balance of risks and benefits to be determined more reliably.
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