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Title: Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts
Author: Estruch Riba, Ramon
Ros Rahola, Emilio
Salas Salvadó, Jordi
Covas Planells, María Isabel
Corella Piquer, Dolores
Arós, Fernando
Gómez Gracia, Enrique
Ruiz-Gutiérrez, Valentina
Fiol Sala, Miguel
Lapetra, José
Lamuela Raventós, Rosa Ma.
Serra Majem, Lluís
Pintó Sala, Xavier
Basora, Josep
Muñoz, Miguel Ángel
Sorlí, José V.
Martínez, José Antonio
Fitó Colomer, Montserrat
Gea, Alfredo
Hernán, M.A.
Martínez-González, Miguel Ángel, 1957-
Mitjavila Cors, Maria Teresa
PREDIMED Study Investigators
Keywords: Cuina mediterrània
Promoció de la salut
Malalties cardiovasculars
Mediterranean cooking
Health promotion
Cardiovascular diseases
Issue Date: 21-Jun-2018
Publisher: Massachusetts Medical Society
Abstract: BACKGROUND: Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk. METHODS: In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) 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 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 a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned. RESULTS: A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol. CONCLUSIONS: In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).
Note: Reproducció del document publicat a:
It is part of: New England Journal of Medicine, 2018, vol. 378, num. 25, p. e34-e34
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ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)
Articles publicats en revistes (Biologia Cel·lular, Fisiologia i Immunologia)
Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Nutrició, Ciències de l'Alimentació i Gastronomia)

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