La prevención primaria con aspirina de enfermedades cardiovasculares en personas diabéticas: revisión de las pruebas disponibles

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Abstract

El beneficio del tratamiento con aspirina en la reducción del riesgo de infarto de miocardio, accidente vascular cerebral y muerte de origen vascular, está bien documentado en personas con enfermedad cardiovascular previa, incluido el subgrupo portador de una diabetes mellitus. Sin embargo el papel de la aspirina en prevención primaria es menos claro y objeto de discusión: los resultados de los ensayos clínicos disponibles no son consistentes, aunque los meta-análisis son favorables en algunos aspectos. Parece existir una disparidad entre el tipo de beneficio (cuando se observa) y el sexo. Y en particular los resultados son contradictorios en personas diabéticas, las cuales representan un pequeño porcentaje de la muestra de población incluida en los estudios. A pesar de esto, la American Diabetes Association desde 1997, y otras sociedades científicas (incluidas varias españolas) desde tiempos más recientes, recomiendan el uso de aspirina a dosis bajas en prevención primaria en todo paciente diabético mayor de 40 años, tipo 1 o tipo 2; y en todos los menores de 40 y mayores de 21 años que presenten otro factor de riesgo cardiovascular, además de la diabetes (antecedentes familiares de enfermedad vascular, hipertensión arterial, tabaquismo, dislipidemia o albuminuria). En este trabajo se revisan los resultados de los ensayos clínicos randomizados y controlados sobre la prevención cardiovascular primaria con aspirina, en los que se podrían apoyar las directrices oficiales de la American Diabetes Association, y se llega a la conclusión de que no existen actualmente pruebas científicas suficientes para sostenerlas.

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Most cited references 33

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A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.

Paul Ridker, Nancy Cook, I-Min Lee … (2005)

Randomized trials have shown that low-dose aspirin decreases the risk of a first myocardial infarction in men, with little effect on the risk of ischemic stroke. There are few similar data in women. We randomly assigned 39,876 initially healthy women 45 years of age or older to receive 100 mg of aspirin on alternate days or placebo and then monitored them for 10 years for a first major cardiovascular event (i.e., nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes). During follow-up, 477 major cardiovascular events were confirmed in the aspirin group, as compared with 522 in the placebo group, for a nonsignificant reduction in risk with aspirin of 9 percent (relative risk, 0.91; 95 percent confidence interval, 0.80 to 1.03; P=0.13). With regard to individual end points, there was a 17 percent reduction in the risk of stroke in the aspirin group, as compared with the placebo group (relative risk, 0.83; 95 percent confidence interval, 0.69 to 0.99; P=0.04), owing to a 24 percent reduction in the risk of ischemic stroke (relative risk, 0.76; 95 percent confidence interval, 0.63 to 0.93; P=0.009) and a nonsignificant increase in the risk of hemorrhagic stroke (relative risk, 1.24; 95 percent confidence interval, 0.82 to 1.87; P=0.31). As compared with placebo, aspirin had no significant effect on the risk of fatal or nonfatal myocardial infarction (relative risk, 1.02; 95 percent confidence interval, 0.84 to 1.25; P=0.83) or death from cardiovascular causes (relative risk, 0.95; 95 percent confidence interval, 0.74 to 1.22; P=0.68). Gastrointestinal bleeding requiring transfusion was more frequent in the aspirin group than in the placebo group (relative risk, 1.40; 95 percent confidence interval, 1.07 to 1.83; P=0.02). Subgroup analyses showed that aspirin significantly reduced the risk of major cardiovascular events, ischemic stroke, and myocardial infarction among women 65 years of age or older. In this large, primary-prevention trial among women, aspirin lowered the risk of stroke without affecting the risk of myocardial infarction or death from cardiovascular causes, leading to a nonsignificant finding with respect to the primary end point. Copyright 2005 Massachusetts Medical Society.

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Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials.

Jeffrey Berger, Maria C. Roncaglioni, Fausto Avanzini … (2006)

Aspirin therapy reduces the risk of cardiovascular disease in adults who are at increased risk. However, it is unclear if women derive the same benefit as men. To determine if the benefits and risks of aspirin treatment in the primary prevention of cardiovascular disease vary by sex. MEDLINE and the Cochrane Central Register of Controlled Trials databases (1966 to March 2005), bibliographies of retrieved trials, and reports presented at major scientific meetings. Eligible studies were prospective, randomized controlled trials of aspirin therapy in participants without cardiovascular disease that reported data on myocardial infarction (MI), stroke, and cardiovascular mortality. Six trials with a total of 95 456 individuals were identified; 3 trials included only men, 1 included only women, and 2 included both sexes. Studies were reviewed to determine the number of patients randomized, mean duration of follow-up, and end points (a composite of cardiovascular events [nonfatal MI, nonfatal stroke, and cardiovascular mortality], each of these individual components separately, and major bleeding). Among 51,342 women, there were 1285 major cardiovascular events: 625 strokes, 469 MIs, and 364 cardiovascular deaths. Aspirin therapy was associated with a significant 12% reduction in cardiovascular events (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.79-0.99; P = .03) and a 17% reduction in stroke (OR, 0.83; 95% CI, 0.70-0.97; P = .02), which was a reflection of reduced rates of ischemic stroke (OR, 0.76; 95% CI, 0.63-0.93; P = .008). There was no significant effect on MI or cardiovascular mortality. Among 44,114 men, there were 2047 major cardiovascular events: 597 strokes, 1023 MIs, and 776 cardiovascular deaths. Aspirin therapy was associated with a significant 14% reduction in cardiovascular events (OR, 0.86; 95% CI, 0.78-0.94; P = .01) and a 32% reduction in MI (OR, 0.68; 95% CI, 0.54-0.86; P = .001). There was no significant effect on stroke or cardiovascular mortality. Aspirin treatment increased the risk of bleeding in women (OR, 1.68; 95% CI, 1.13-2.52; P = .01) and in men (OR, 1.72; 95% CI, 1.35-2.20; P<.001). For women and men, aspirin therapy reduced the risk of a composite of cardiovascular events due to its effect on reducing the risk of ischemic stroke in women and MI in men. Aspirin significantly increased the risk of bleeding to a similar degree among women and men.