Primary prevention of cardiovascular disease with a Mediterranean diet
Authors: Ll Quinzavos
E Padres
J Tur
Lluís Serra-Majem
M T Bonet
M Cofán
C Simón
A Isach
P Buil-Cosiales
I Felipe
M García
C Viñas
F Fiol
Jordi Salas-Salvadó
C Lama
J M Hernández
J Fernández-Ballart
R Osma
J M Nuñez-Córdoba
J  Sánchez Perona
F B Hu
B Costa
A Jover
R Elosúa
A Sánchez-Tainta
PREDIMED Study Investigators
G Chiva
J Álvarez-Pérez
P Román
J Vila
Rosa Maria Lamuela-Raventos
I  Bautista Castaño
C Razquin
M  García García
X Solanich
A  Alonso Gómez
J Amat
E  Díez Benítez
A García-Arellano
A I Castellote-Bargallo
J Salas-Salvadó
A  Baca Osorio
A Rovira
N Babio
M  Bianchi Alba
J Algorta
M Doménech
J de Diego Salas
M Oller
J J  Sánchez Luque
A  Urtasun Samper
M S Sánchez
Josep Basora
Ma D  García de la Noceda Montoy
R González
I Salaverría
J Portu
F  José García
A Ramos
E Corbella
P Iglesias
M Moñino
R  Benítez Pont
A Gea
E Sacanella
J M Verdú
A Sanmartín
J Marrugat
P Baby
A Medina-Remón
Xavier Pintó
F Sarmiendo de la Fe
José V Sorlí
S Romero
R De la Torre
R Prieto
M García-Valdueza
E Sanz
A Altés
L de Santamaría
J Benavent
J  García Roselló
S  Arranz J M Baena
R Gómez-Huelgas
E Martínez
Y García
J I González
N Bargalló
E Mayoral
Fernando Arós
J Gállego
R Figueras
B  Churio Beraza
A Alonso
F Arós
T del Hierro
S Millán
C Iglesias
E Sánchez
C Sánchez
A Proenza
G Flores
Ramón Estruch
L Mengual
J San Vicente
Miguel Angel Martínez-González
M Bes-Rastrollo
E M Asensio
J  Gil Zarzosa
Miguel Angel Muñoz
M Ortega-Calvo
A Tresserra-Rimbau
F Trias
L García
A Serrano
M Fitó
O Coltell
C Alegret
C de Juan
X Pi-Sunyer
I Duaso
B Sanjulián
M Serrano-Martínez
José Alfredo Martínez
C Valls-Pedret
T Basora
E de la Cruz
J Timiraus
V Pascual
Ma T  Arceiz Campo
Y Corchado
José Lapetra
Maria-Isabel Covas
P Carrasco
C Riera
G Sáez
A Martí
T  Sagredo Arce
J Altirriba
Enrique Gómez-Gracia
C Cabezas
J Clos
M Aldamiz
A Brau
M Bulló
M Mata
A Girbés
C Ortega-Azorín
Dolores Corella
R Tort
J M Santos
J García
A Sala-Vila
H Schröder
M Guillén
E Ros
D Corella
M A Martínez-González
P Guillem-Saiz
J Valderrama
L García-Pérez
R Pujol
V Santamaría
Emilio Ros
M T Mitjavila
R Gilabert
M Liroz
A Sánchez-Villegas
C Molina
C Saiz
E Lázaro
E  Jurado Ruiz
L Forga
J Martínez-González
B  Macías Gutiérrez
M I Santamaría
R Casas
I  Maldonado Díaz
M Serra
D Muñoz-Aguayo
I  Falcón Sanabria
P Roura
R Estruch
C A González
E H Martínez-Lapiscina
J L Piñol
M I Covas
S Tello
M C López-Sabater
C  Simón García
A Guarner
G Frontera
N Berrade
A Larrauri
N Ibarrola
E  Montero Romero
Ma V  Gueto Rubio
O Portolés
M Ferrer
P Martínez
M Garcia-Lopez
J Sabaté
I Pla
F J Basterra-Gortari
M Ginard
Miquel Fiol
M García Layana
J Berjón
A Loma-Osorio
S Francisco
A J  Santana Santana
J Díez-Espino
I Sarasa
Z Plá
M Amorós
J  Villanueva Tellería
Ll Parra
A Galera
M P Portillo
E Vinyoles
N Ortuño
E Toledo
I Zazpe
J Wärnberg
Valentina Ruiz-Gutiérrez
V Extremera-Urabayen
P Valderas
A Pérez-Heras
V  Velasco García
J J Cabré
C Arroyo-Azpa
J Fernández-Crehuet Navajas
M Sorli
M T Martin
F Márquez
M Leal
F  Cortés Ugalde
F Martin
M A Rovira
Ma D  Vigata López
Y Soler
E Manzano
E  Vargas López
M C Yuste
Journal: New England Journal of Medicine (2013)
Discipline: CLINICAL MEDICINE
Keywords: Mediterranean diet; cardiovascular risk; primary prevention; randomized trial; cardiovascular events
Affiliations: Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid, Spain. , The authors' affiliations are listed in the Appendix.

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.). 

Retracted: No

PubPeer comments:
 http: blogs.plos.org absolutely-maybe 2018 06 14 what-does-the-predimed-trial-retraction-re-boot-mean-for-the-mediterranean-diet , 
 Note that this article was retracted and replaced in 2018. That being said, when you visit the link below, it simply says  This article has been retracted (in a small font at the top) with no mention of why it was retracted and no link to the new article (unless I misunderstand and the article below _is_ the replacement). Link: https: www.nejm.org doi full 10.1056 NEJMoa1200303 , 
 This article currently leads the Retraction Watch leaderboard of the most highly cited retracted papers: https: retractionwatch.com the-retraction-watch-leaderboard top-10-most-highly-cited-retracted-papers Amassing over 1000 citations since the retraction. , 
 See also: https: www.npr.org sections health-shots 2018 06 13 619619302 researchers-soften-claim-that-mediterranean-diet-prevents-heart-attacks?live=1 , 
 #3 That was the reason I checked it out, I wondered how a retracted article could amass literally hundreds of citations per year. , 
 I agree that NEJM didn t do a good job in marking and explaining the retraction of the paper. Partially it could be also due to the re-publication of the altered article. Let s comment under some of the recent papers that cited it, to see if some of the authors reply. ,