RT Journal Article
T1 Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts.
A1 Estruch, Ramón
A1 Ros, Emilio
A1 Salas-Salvadó, Jordi
A1 Covas, Maria-Isabel
A1 Corella, Dolores
A1 Arós, Fernando
A1 Gómez-Gracia, Enrique
A1 Ruiz-Gutiérrez, Valentina
A1 Fiol, Miquel
A1 Lapetra, José
A1 Lamuela-Raventos, Rosa M
A1 Serra-Majem, Lluís
A1 Pintó, Xavier
A1 Basora, Josep
A1 Muñoz, Miguel A
A1 Sorlí, José V
A1 Martínez, J Alfredo
A1 Fitó, Montserrat
A1 Gea, Alfredo
A1 Hernán, Miguel A
A1 Martínez-González, Miguel A
A1 PREDIMED Study Investigators, 
AB Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk. 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 We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the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. 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. 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 .).
YR 2018
FD 2018-06-13
LK http://hdl.handle.net/10668/12587
UL http://hdl.handle.net/10668/12587
LA en
DS RISalud
RD Apr 20, 2025