The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk

• Autores: Spiegelman, Donna; Lovato, Laura C.; Khudyakov, Polyna; Wilkens, Trine L.; Adebamowo, Clement A.; Adebamowo, Sally N.; Appel, Lawrence J.; Beulens, Joline W.J.; Coughlin, Janelle W.; Dragsted, Lars Ove; Edenberg, Howard J; Eriksen, Jane N.; Estruch, Ramon; Grobbee, Diederick E.; Gulayin, Pablo Elías; Irazola, Vilma; Krystal, John H.; Lazo, Mariana; Murray, Margaret M.; Rimm, Eric B.; Schrieks, Ilse C.; Williamson, Jeff D.; Mukamal, Kenneth J.
• Año de publicación: 2020
• Idioma: inglés
• Tipo de recurso: artículo
• Materia: CARDIOVASCULAR DISEASES; DIABETES MELLITUS TYPE 2; ETHANOL; GERIATRIC; RANDOMIZED CONTROLLED TRIAL; RESEARCH DESIGN
• Institución: Consejo Nacional de Investigaciones Científicas y Técnicas

Background: Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations. Aim: The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older. Methods: This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11–15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer. Results: We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals. Conclusions: We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.
Fil: Spiegelman, Donna. Harvard University. Harvard School of Public Health; Estados Unidos
Fil: Lovato, Laura C.. Universidad de Barcelona; España
Fil: Khudyakov, Polyna. Harvard University. Harvard School of Public Health; Estados Unidos. Universidad de Barcelona; España
Fil: Wilkens, Trine L.. Universidad de Copenhagen; Dinamarca
Fil: Adebamowo, Clement A.. University of Maryland; Estados Unidos
Fil: Adebamowo, Sally N.. University of Maryland; Estados Unidos
Fil: Appel, Lawrence J.. No especifíca;
Fil: Beulens, Joline W.J.. No especifíca;
Fil: Coughlin, Janelle W.. No especifíca;
Fil: Dragsted, Lars Ove. Universidad de Copenhagen; Dinamarca
Fil: Edenberg, Howard J. No especifíca;
Fil: Eriksen, Jane N.. Universidad de Copenhagen; Dinamarca
Fil: Estruch, Ramon. Universidad de Barcelona; España
Fil: Grobbee, Diederick E.. No especifíca;
Fil: Gulayin, Pablo Elías. No especifíca;
Fil: Irazola, Vilma. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Krystal, John H.. University of Yale. School of Medicine; Estados Unidos
Fil: Lazo, Mariana. No especifíca;
Fil: Murray, Margaret M.. University of Yale. School of Medicine; Estados Unidos
Fil: Rimm, Eric B.. Harvard University. Harvard School of Public Health; Estados Unidos
Fil: Schrieks, Ilse C.. Universidad de Barcelona; España
Fil: Williamson, Jeff D.. No especifíca;
Fil: Mukamal, Kenneth J.. Harvard Medical School; Estados Unidos