title: Empirically-derived food patterns and the risk of total mortality and cardiovascular events in the PREDIMED study.
abstract: OBJECTIVE
  There is little evidence on post hoc-derived dietary patterns (DP) and all-cause mortality in Southern-European populations. Furthermore, the potential effect modification of a DP by a nutritional intervention has not been sufficiently assessed. We assessed the association between a posteriori defined baseline major DP and total mortality or cardiovascular events within each of the three arms of a large primary prevention trial (PREDIMED) where participants were randomized to two active interventions with Mediterranean-type diets or to a control group (allocated to a low-fat diet).
  
  
  METHODS
  We followed-up 7216 participants for a median of 4.3 years. A validated 137-item food-frequency questionnaire was administered. Baseline DP were ascertained through factor analysis based on 34 predefined groups. Cox regression models were used to estimate multivariable-adjusted hazard ratios (HR) for cardiovascular disease (CVD) or mortality across quartiles of DP within each of the three arms of the trial.
  
  
  RESULTS
  We identified two major baseline DP: the first DP was rich in red and processed meats, alcohol, refined grains and whole dairy products and was labeled Western dietary pattern (WDP). The second DP corresponded to a "Mediterranean-type" dietary pattern (MDP). During follow-up, 328 participants died. After controlling for potential confounders, higher baseline adherence to the MDP was associated with lower risk of CVD (adjusted HR for fourth vs. first quartile: 0.52; 95% CI (Confidence Interval): 0.36, 0.74; p-trend <0.001) and all-cause mortality (adjusted HR: 0.53; 95% CI: 0.38, 0.75; p-trend <0.001), regardless of the allocated arm of the trial. An increasing mortality rate was found across increasing quartiles of the WDP in the control group (allocated to a low-fat diet), though the linear trend was not statistically significant (p = 0.098).
  
  
  CONCLUSIONS
  Higher adherence to an empirically-derived MDP at baseline was associated with a reduced risk of CVD and mortality in the PREDIMED trial regardless of the allocated arm. The WDP was not associated with higher risk of mortality or cardiovascular events.
authors.affiliation: Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain; CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain. Electronic address: mamartinez@unav.es.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Martínez-González
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Nutrition and Food Sciences and Physiology, University of Navarra, Pamplona, Spain.
authors.forename: Itziar
authors.initials: I
authors.lastname: Zazpe
authors.affiliation: Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Razquin
authors.affiliation: Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain; CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Sánchez-Tainta
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Preventive Medicine, University of Valencia, Valencia, Spain.
authors.forename: Dolores
authors.initials: D
authors.lastname: Corella
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Human Nutrition Department, IISPV, Universitat Rovira i Virgili, Reus, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Salas-Salvadó
authors.affiliation: Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain; CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain.
authors.forename: Estefanía
authors.initials: E
authors.lastname: Toledo
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Institut d'Investigacions Biomediques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Ros
authors.affiliation: Unitat de Suport a la Recerca, División de Atención Primaria de Salud, Institut Català de la Salut e IDIAP-Jordi Gol, Barcelona, Spain; Departamento de Pediatría, Obstetricia, Ginecología y Medicina Preventiva, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Muñoz
authors.affiliation: Department of Cardiology, University Hospital of Alava, Vitoria, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Recondo
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Preventive Medicine, University of Malaga, Malaga, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Gómez-Gracia
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Instituto de Investigación Sanitaria de Palma (IdISPa), Hospital Son Espases, Palma de Mallorca, Spain.
authors.forename: Miquel
authors.initials: M
authors.lastname: Fiol
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Lapetra
authors.affiliation: Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain; CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Servicio Navarro de Salud-Osasunbidea, Pamplona, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Buil-Cosiales
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Clinical Sciences, University of Las Palmas de Gran Canaria, Las Palmas, Spain.
authors.forename: Lluis
authors.initials: L
authors.lastname: Serra-Majem
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Pinto
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Cardiovascular and Nutrition Research Group, Institut de Recerca Hospital del Mar-IMIM, Barcelona, Spain; CIBER Epidemiologia y Salud Pública (CIBERESP), Spain.
authors.forename: Helmut
authors.initials: H
authors.lastname: Schröder
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Fundamental Biology & Health Sciences, University of Balearic Islands, Spain.
authors.forename: Josep A
authors.initials: JA
authors.lastname: Tur
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Preventive Medicine, University of Valencia, Valencia, Spain.
authors.forename: José V
authors.initials: JV
authors.lastname: Sorli
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Department of Nutrition and Food Science, School of Pharmacy, XaRTA, INSA, University of Barcelona, Barcelona, Spain.
authors.forename: Rosa M
authors.initials: RM
authors.lastname: Lamuela-Raventós
authors.affiliation: CIBER Fisiopatologia de la Obesidad y Nutricion (CIBERobn) and PREDIMED Network (RD 06/0045), Instituto de Salud Carlos III (ISCIII) Spanish Government, Spain; Institut d'Investigacions Biomediques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Ramón
authors.initials: R
authors.lastname: Estruch
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000401:mortality* / Q000517:prevention & control; D018752:Diet, Fat-Restricted; D038441:Diet, Mediterranean; D036262:Empirical Research; D002149:Energy Intake; D005060:Europe; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D015596:Nutrition Assessment; D010349:Patient Compliance; D016016:Proportional Hazards Models; D012307:Risk Factors; D011795:Surveys and Questionnaires
keywords: Cardiovascular risk; Dietary pattern; Mediterranean diet; Mortality; PREDIMED