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      La prevención primaria con aspirina de enfermedades cardiovasculares en personas diabéticas: Revisión de las pruebas disponibles Translated title: Aspirin for the Primary Prevention of Cardiovascular Diseases in Diabetic Patients: A Review of Currently Available Tests

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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.

          Translated abstract

          The benefits of aspirin treatment in reducing the risk of myocardial infarction, cerebrovascular accidents and vascular death is well-documented among individuals having prior cardiovascular disease, including the subgroup with diabetes mellitus. The role of aspirin in primary prevention is less clear and debatable: the results of the clinical trials currently available are not consistent, although the meta-analyses are favorable in some aspects. There seems to be a disparity between the type of benefit (when found to exist) and gender, the findings being particularly contradictory for diabetic subjects, totalling a minor percentage of the population sample included in the studies. Despite this fact, in 1997, the American Diabetes Association and more recently other scientific societies (including several Spanish societies) have been recommending the use of aspirin in low doses in primary prevention in all type 1 or type 2 diabetic patients over 40 years of age and in all those within the 21-40 age range having any other cardiovascular risk factor in addition to diabetes (family history of vascular disease, hypertension, smoking, dyslipidemia or albuminuria). This study reviews the findings of the randomized, controlled clinical trials on primary cardiovascular prevention with aspirin, on which the official American Diabetes Association guidelines might be based, the conclusion being reached that there is not currently sufficient scientific evidence to uphold these guidelines.

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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.

          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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            Collaborative overview of randomised trials of antiplatelet therapy Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients

            (1994)
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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.

              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.
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                Author and article information

                Journal
                resp
                Revista Española de Salud Pública
                Rev. Esp. Salud Publica
                Ministerio de Sanidad, Consumo y Bienestar social (Madrid, Madrid, Spain )
                1135-5727
                2173-9110
                December 2006
                : 80
                : 6
                : 613-620
                Affiliations
                Avilés orgnameÁrea III del Servicio de Salud del Principado de Asturias orgdiv1Sección de Endocrinología
                Avilés Asturias orgnameHospital San Agustín de Avilés orgdiv1Sección de Endocrinología
                Sotrondio orgnameÁrea VIII del Servicio de Salud del Principado de Asturias orgdiv1Centro de Salud de Sotrondio
                Article
                S1135-57272006000600002 S1135-5727(06)08000600002
                10.1590/s1135-57272006000600002

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 International License.

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