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Ensayo controlado aleatorizado2013Financiado por la industriaVínculos de autores con la industriaAcceso abierto

Financiado en parte por Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Sanofi, Boston Scientific Corporation, Astellas Pharma, Servier, Daiichi Sankyo Europe

Long-term effects of statin treatment in elderly people: extended follow-up of the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER)

Lloyd SM, Stott DJ, de Craen AJ, Kearney PM, Sattar N, Perry I, Packard CJ, Briggs A, Marchbank L, Comber H, Jukema JW, Westendorp RG, Trompet S, Buckley BM, Ford I

PloS one · 44 citas

Etiquetas de revisión

Vínculos de autores con la industriaFinanciado por la industria

Datos 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
Financiado por la industria
Empresa
Bristol-Myers Squibb
Empresa
Eli Lilly and Company
Empresa
Pfizer
Empresa
Sanofi
Empresa
Boston Scientific Corporation
Organización sin fines de lucro
Wellcome Trust
Empresa
Astellas Pharma
Empresa
Servier
Empresa
Daiichi Sankyo Europe
Gobierno
Chief Scientist Office
Autores
Al menos un autor declara un vínculo económico con la industria

Según 10 financiadores declarados y la declaración de financiación del texto completo.

Publicación

Publicado
2013-09-02 · PLoS One · vol. 8 · número 9 · pág. e72642
Editorial
Public Library of Science
Citado
64 citas · más que el 95% de estudios similares · 5.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
21 trabajos
Acceso
Acceso abierto (revista) · CC-BY
Áreas de investigación
Lipoproteins and Cardiovascular Health · Cancer, Lipids, and Metabolism · Acute Myocardial Infarction Research
Palabras clave
pravastatin, statin therapy, older adults, long-term cardiovascular outcomes, coronary heart disease mortality, cancer risk, all-cause mortality, stroke, competing risk of death, PROSPER trial, post-trial follow-up, hypercholesterolemia
MeSH
humans, coronary disease, pravastatin, hydroxymethylglutaryl-coa reductase inhibitors, prospective studies, aged, aged, 80 and over, netherlands, female, male

15 autores

  • Suzanne M. Lloyd🇬🇧University of Glasgow
  • David J. Stott🇬🇧University of Glasgow
  • Anton J.M. de Craen🇳🇱Leiden University Medical Center
  • Patricia M. Kearney🇮🇪University College Cork
  • Naveed A. Sattar🇬🇧University of Glasgow
  • Ivan J. Perry🇮🇪University College Cork
  • Christopher J. Packard🇬🇧National Health Service
  • Andrew H. Briggs🇬🇧University of Glasgow
  • Laura Marchbank🇬🇧National Health Service Scotland
  • Harry Comber🇮🇪National Cancer Registry
  • J. Wouter Jukema🇳🇱Leiden University Medical Center
  • Rudi G. J. Westendorp🇳🇱Leiden University Medical Center
  • Stella Trompet🇳🇱Leiden University Medical Center
  • Brendan Martin Buckley🇮🇪University College Cork
  • Ian Ford🇬🇧 · autor de correspondenciaUniversity of Glasgow

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER), a placebo-controlled trial of pravastatin, demonstrated a 19% reduction in coronary outcomes (p=0.006) after a mean of 3.2 years, with no impact on stroke outcomes or all-cause mortality. However, there was a suggestion of increased cancer risk. Our aim is to determine the long-term benefits and safety of pravastatin treatment in older people using post-trial follow-up of the PROSPER participants.

Methods

5,804 (2,520 Scottish) men and women aged 70-82 years with either pre-existing vascular disease or increased risk of such disease because of smoking, hypertension or diabetes, were randomised to 40 mg pravastatin or matching placebo. Using record linkage to routinely collected health records, all participants (full cohort) were linked to death and cancer registries, and the Scottish cohort additionally to hospital admissions, to provide composite fatal/non-fatal cardiovascular outcomes (total mean follow-up 8.6 years).

Results

Pravastatin treatment for 3.2 years reduced CHD death in the full cohort, hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.68-0.95, p=0.0091 and fatal coronary events or coronary hospitalisations in the Scottish cohort (HR 0.81, 95% CI 0.69-0.95, p=0.0081) over 8.6 years. There was no reduction in stroke or all-cause mortality. Cancer risk was not increased in the full cohort (HR 1.08, 95% CI 0.96-1.21, p=0.22).

Conclusions

Pravastatin treatment of elderly high-risk subjects for 3.2 years provided long-term protection against CHD events and CHD mortality. However, this was not associated with any increase in life expectancy, possibly due to competing mortality with deaths from other causes. There was no evidence of long-term increased risk of cancer.

Trial registration

ISRCTN40976937.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).

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