Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/157477
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dc.contributor.authorEstruch Riba, Ramon-
dc.contributor.authorRos Rahola, Emilio-
dc.contributor.authorSalas Salvadó, Jordi-
dc.contributor.authorCovas Planells, María Isabel-
dc.contributor.authorCorella Piquer, Dolores-
dc.contributor.authorArós, Fernando-
dc.contributor.authorGómez Gracia, Enrique-
dc.contributor.authorRuiz-Gutiérrez, Valentina-
dc.contributor.authorFiol Sala, Miguel-
dc.contributor.authorLapetra, José-
dc.contributor.authorLamuela Raventós, Rosa Ma.-
dc.contributor.authorSerra Majem, Lluís-
dc.contributor.authorPintó Sala, Xavier-
dc.contributor.authorBasora, Josep-
dc.contributor.authorMuñoz, Miguel Ángel-
dc.contributor.authorSorlí, José V.-
dc.contributor.authorMartínez, José Antonio-
dc.contributor.authorFitó Colomer, Montserrat-
dc.contributor.authorGea, Alfredo-
dc.contributor.authorHernán, M.A.-
dc.contributor.authorMartínez-González, Miguel Ángel, 1957--
dc.contributor.authorMitjavila Cors, Maria Teresa-
dc.contributor.authorPREDIMED Study Investigators-
dc.date.accessioned2020-04-24T15:01:04Z-
dc.date.available2020-04-24T15:01:04Z-
dc.date.issued2018-06-21-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/2445/157477-
dc.description.abstractBACKGROUND: 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 .).-
dc.format.extent14 p.-
dc.format.mimetypeapplication/pdf-
dc.language.isoeng-
dc.publisherMassachusetts Medical Society-
dc.relation.isformatofReproducció del document publicat a: https://doi.org/10.1056/NEJMoa1800389-
dc.relation.ispartofNew England Journal of Medicine, 2018, vol. 378, num. 25, p. e34-e34-
dc.relation.urihttps://doi.org/10.1056/NEJMoa1800389-
dc.rights(c) Massachusetts Medical Society, 2018-
dc.sourceArticles publicats en revistes (Nutrició, Ciències de l'Alimentació i Gastronomia)-
dc.subject.classificationCuina mediterrània-
dc.subject.classificationPromoció de la salut-
dc.subject.classificationMalalties cardiovasculars-
dc.subject.otherMediterranean cooking-
dc.subject.otherHealth promotion-
dc.subject.otherCardiovascular diseases-
dc.titlePrimary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts-
dc.typeinfo:eu-repo/semantics/article-
dc.typeinfo:eu-repo/semantics/publishedVersion-
dc.identifier.idgrec687637-
dc.date.updated2020-04-24T15:01:05Z-
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess-
dc.identifier.pmid29897866-
dc.identifier.pmid30281995-
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)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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