ASCEND: A Study of Cardiovascular Events iN Diabetes: Characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes
Bowman L, Mafham M, Stevens W, Haynes R, Aung T, Chen F, Buck G, Collins R, Armitage J, ASCEND Study Collaborative Group
American heart journal · 83 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
- Financiado por la industria
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- British Heart Foundation
- Gobierno
- Medical Research Council
- Subvenciones
- British Heart Foundation (SP/08/010/25939); British Heart Foundation (SP/14/3/31114)
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2017-12-23 · Am Heart J · vol. 198 · págs. 135–144
- Editorial
- Elsevier BV
- Citado
- 106 citas · más que el 97% de estudios similares · 6.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 40 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Antiplatelet Therapy and Cardiovascular Diseases · Fatty Acid Research and Health · Inflammatory mediators and NSAID effects
- Palabras clave
- aspirin, omega-3 fatty acids, diabetes mellitus, cardiovascular disease prevention, primary prevention, antiplatelet therapy, cancer prevention, gastrointestinal bleeding, factorial trial, baseline characteristics, HbA1c, serum lipids
- MeSH
- humans, cardiovascular diseases, diabetes mellitus, aspirin, fatty acids, omega-3, prognosis, treatment outcome, drug administration schedule, survival rate, risk assessment, retrospective studies, dose-response relationship, drug, patient selection, reference values, aged, middle aged, female, male, secondary prevention, united kingdom
9 autores
- Louise J. Bowman🇬🇧 · autor de correspondenciaUniversity of Oxford; MRC Population Health Research Unit
- Marion M. Mafham🇬🇧University of Oxford; MRC Population Health Research Unit
- William Stevens🇬🇧University of Oxford; MRC Population Health Research Unit
- Richard Haynes🇬🇧University of Oxford; MRC Population Health Research Unit
- Theingi Aung🇬🇧Royal Berkshire Hospital
- Fang Chen🇬🇧University of Oxford; MRC Population Health Research Unit
- Georgina A. N. Buck🇬🇧University of Oxford; MRC Population Health Research Unit
- Rory Collins🇬🇧University of Oxford; MRC Population Health Research Unit
- Jane Armitage🇬🇧University of Oxford; MRC Population Health Research Unit
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objectives
The use of aspirin for the secondary prevention of cardiovascular disease (CVD) is firmly established, and the proportional reductions in heart attacks and strokes appear to be similar in people with and without diabetes. Uncertainty remains about the role of antiplatelet treatments for primary prevention of CVD, and guidelines vary in their recommendations. It has also been hypothesized that long-term aspirin can prevent gastro-intestinal and other cancers. Observational studies suggest associations between higher intakes of omega-3 fatty acids (FA) and lower rates of CVD, but there is no large-scale randomized evidence to support using prophylactic omega-3 FA supplementation in primary prevention. ASCEND is a randomized trial assessing whether 100 mg daily aspirin safely prevents CVD and cancer in patients with diabetes without known arterial disease. It is also assessing whether supplementation with 1 g omega-3 FA daily prevents CVD. This paper describes the methods and baseline characteristics of the randomized participants.
Methods and results
Between 2005 and 2011, using mail-based methods, 15,480 people with diabetes were randomized to aspirin versus placebo and, in a factorial design, to omega-3 FA supplementation versus placebo. Blood and urine samples were collected to allow baseline stratification by biochemical prognostic variables (e.g. HbA1c, blood lipids). Follow-up is for a median of at least 7 years.
Conclusions
Demonstrating that prophylactic aspirin safely reduces the risk of CVD or cancer in the primary prevention setting, or that omega-3 FA supplementation prevents CVD, would be relevant to hundreds of millions of people worldwide who are currently not receiving such therapies. The results of ASCEND will be reported in 2018.
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