Primary Prevention of Cardiovascular
Disease with a Mediterranean Diet
Ramon Estruch, M.D., Ph.D., Emilio Ros, M.D., Ph.D., Jordi Salas-Salvado, M.D., Ph.D.,
Maria-Isabel Covas, D.Pharm., Ph.D., Dolores Corella, D.Pharm., Ph.D.,
Fernando Aros, M.D., Ph.D., Enrique Gomez-Gracia, M.D., Ph.D.,
Valentina Ruiz-Gutierrez, Ph.D., MiquelFiol, M.D., Ph.D., Jose Lapetra, M.D., Ph.D.,
Rosa Maria Lamuela-Raventos, D.Pharm., Ph.D., Lluis Serra-Majem, M.D., Ph.D.,
Xavier Pinto, M.D., Ph.D., JosepBasora, M.D., Ph.D., Miguel Angel Munoz, M.D., Ph.D.,
Jose V. Sorli, M.D., Ph.D., Jose Alfredo Martinez, D.Pharm, M.D., Ph.D., and
Miguel Angel Martinez-Gonzalez, M.D., Ph.D., for the PREDIMED Study Investigators
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.
In a multicenter trial, 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.
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.
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 Instituto de Salud Carlos III, Spanish government, and others;
Controlled-Trials.com number, ISRCTN35739639.)
Copyright © 2013 Massachusetts Medical Society.