N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.
Primary prevention of cardiovascular disease with a Mediterranean diet.
Estruch R1,
Ros E,
Salas-Salvadó J,
Covas MI,
Corella D,
Arós F,
Gómez-Gracia E,
Ruiz-Gutiérrez V,
Fiol M,
Lapetra J,
Lamuela-Raventos RM,
Serra-Majem L,
Pintó X,
Basora J,
Muñoz MA,
Sorlí JV,
Martínez JA,
Martínez-González MA;
PREDIMED Study Investigators.
Estruch R, Corella D, Covas MI, Martínez-González MA, Ros E, Salas-Salvadó J, Arós F, Aldamiz M, Alonso A, Berjón J, Forga L, Gállego J, García Layana M, Larrauri A, Portu J, Timiraus J, Serrano-Martínez M, Ros E, Covas MI, Martínez-González MA, Pérez-Heras A, Salas-Salvadó J, Serra M, Pi-Sunyer X, González CA, Hu FB, Sabaté J, Serra M, Pérez-Heras A, Viñas C, Casas R, de Santamaría L, Romero S, Sacanella E, Chiva G, Valderas P, Baena S, García M, Oller M, Amat J, Duaso I, García Y, Iglesias C, Simón C, Quinzavos L, Parra L, Liroz M, Benavent J, Clos J, Pla I, Amorós M, Bonet MT, Martin MT, Sánchez MS, Altirriba J, Manzano E, Altés A, Cofán M, Valls-Pedret C, Sala-Vila A, Doménech M, Gilabert R, Bargalló N, Sánchez-Tainta A, Sanjulián B, Toledo E, Bes-Rastrollo M, Martí A, Razquin C, Buil-Cosiales P, Serrano-Martínez M, Díez-Espino J, García-Arellano A, Zazpe I, Basterra-Gortari FJ, Martínez-Lapiscina EH, Gea A, Garcia-Lopez M, Nuñez-Córdoba JM, Ortuño N, Berrade N, Extremera-Urabayen V, Arroyo-Azpa C, García-Pérez L, Tellería J, Ugalde F, Arce T, Montoy MD, López MD, Campo MT, Samper A, Rubio MV, Beraza B, Bulló M, González R, Molina C, Márquez F, Babio N, Sorli M, Roselló J, Martin F, Tort R, Isach A, Costa B, Cabré JJ, Fernández-Ballart J, Ibarrola N, Alegret C, Martínez P, Millán S, Piñol JL, Basora T, Hernández JM, Tello S, Vila J, Fitó M, Schröder H, De la Torre R, Muñoz-Aguayo D, Elosúa R, Marrugat J, Ferrer M, Carrasco P, Osma R, Guillén M, Guillem-Saiz P, Portolés O, Pascual V, Riera C, Valderrama J, Serrano A, Lázaro E, Sanmartín A, Girbés A, Santamaría V, Sánchez C, Plá Z, Sánchez E, Ortega-Azorín C, González JI, Saiz C, Coltell O, Asensio EM, Salaverría I, del Hierro T, Algorta J, Francisco S, Alonso A, San Vicente J, Sanz E, Felipe I, Gómez A, Loma-Osorio A, Pont R, Alba M, Navajas JF, Wärnberg J, Gómez-Huelgas R, Martínez-González J, García V, Salas Jde D, Osorio A, Zarzosa J, Luque JJ, López E, Perona J, Romero E, García M, Ruiz E, García-Valdueza M, Moñino M, Proenza A, Prieto R, Frontera G, Ginard M, Fiol F, Jover A, García J, Leal M, Martínez E, Santos JM, Ortega-Calvo M, Román P, García F, Iglesias P, Corchado Y, Mayoral E, Lama C, López-Sabater MC, Castellote-Bargallo AI, Medina-Remón A, Tresserra-Rimbau A, Álvarez-Pérez J, Benítez E, Castaño I, Díaz I, Sánchez-Villegas A, de la Fe FS, García C, Sanabria I, Gutiérrez B, Santana AJ, de la Cruz E, Galera A, Soler Y, Trias F, Sarasa I, Padres E, Figueras R, Solanich X, Pujol R, Corbella E, Cabezas C, Vinyoles E, Rovira MA, García L, Flores G, Verdú JM, Baby P, Ramos A, Mengual L, Roura P, Yuste MC, Guarner A, Rovira A, Santamaría MI, Mata M, de Juan C, Brau A, Mitjavila MT, Portillo MP, Sáez G, Tur J.
- 1
- Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid, Spain. restruch@clinic.ub.es
Corrected and republished in
Abstract
BACKGROUND:
Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events.
METHODS:
In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years.
RESULTS:
A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported.
CONCLUSIONS:
Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).
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