The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?

AIMS: To address potential controversies on the health benefits of the Mediterranean diet (MedDiet) after PREDIMED, a randomized trial of MedDiet for primary cardiovascular prevention. We have focused on: a) the PREDIMED study design, b) analysis of PREDIMED data and c) interpretation of its results...

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Autores: Guasch Ferré, Marta, Salas-Salvadó, Jordi, Ros, Emilio, Estruch, Ramón, Corella, Dolores, Fitó Colomer, Montserrat, Martínez-González, Miguel Ángel, 1957-, PREDIMED investigators
Tipo de recurso: artículo
Estado:Versión aceptada para publicación
Fecha de publicación:2017
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/35066
Acceso en línea:http://hdl.handle.net/10230/35066
http://dx.doi.org/10.1016/j.numecd.2017.05.004
Access Level:acceso abierto
Palabra clave:Dieta mediterrània
Cardiovascular disease
Clinical trial
Mediterranean diet
PREDIMED
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oai_identifier_str oai:recercat.cat:10230/35066
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
title The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
spellingShingle The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
Guasch Ferré, Marta
Dieta mediterrània
Cardiovascular disease
Clinical trial
Mediterranean diet
PREDIMED
title_short The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
title_full The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
title_fullStr The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
title_full_unstemmed The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
title_sort The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?
dc.creator.none.fl_str_mv Guasch Ferré, Marta
Salas-Salvadó, Jordi
Ros, Emilio
Estruch, Ramón
Corella, Dolores
Fitó Colomer, Montserrat
Martínez-González, Miguel Ángel, 1957-
PREDIMED investigators
author Guasch Ferré, Marta
author_facet Guasch Ferré, Marta
Salas-Salvadó, Jordi
Ros, Emilio
Estruch, Ramón
Corella, Dolores
Fitó Colomer, Montserrat
Martínez-González, Miguel Ángel, 1957-
PREDIMED investigators
author_role author
author2 Salas-Salvadó, Jordi
Ros, Emilio
Estruch, Ramón
Corella, Dolores
Fitó Colomer, Montserrat
Martínez-González, Miguel Ángel, 1957-
PREDIMED investigators
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Dieta mediterrània
Cardiovascular disease
Clinical trial
Mediterranean diet
PREDIMED
topic Dieta mediterrània
Cardiovascular disease
Clinical trial
Mediterranean diet
PREDIMED
description AIMS: To address potential controversies on the health benefits of the Mediterranean diet (MedDiet) after PREDIMED, a randomized trial of MedDiet for primary cardiovascular prevention. We have focused on: a) the PREDIMED study design, b) analysis of PREDIMED data and c) interpretation of its results. DATA SYNTHESIS: Regarding the design of the trial, its early termination and between-group differences in the intensity of the intervention are potential causes of concern. The planned duration was 6 years but the trial was prematurely stopped when an interim analysis at 4.8-year provided sufficient evidence of benefit for the two MedDiets. In the MedDiet groups supplemented with extra-virgin olive oil or mixed-nuts, the primary composite endpoint (myocardial infarction, stroke, or cardiovascular death) was reduced by 30% and 28% respectively, as compared with the control group. Final results did not change after taking into account the different intensity of educational efforts during the trial. Other potential doubts related to data analysis (e.g., intention to treat versus a per-protocol approach, and consequences of dropouts) should not be causes of concern. Finally, we addressed alternative interpretations of the effect on all-cause mortality. The protocol-defined primary endpoint was a composite cardiovascular endpoint, not all-cause mortality. To analyze total mortality, we would have needed a much larger sample size and longer follow-up. Therefore, the PREDIMED results cannot be used to draw firm conclusions on MedDiets and all-cause mortality. CONCLUSIONS: The PREDIMED study was designed to overcome three major problems of previous nutritional research: a) residual confounding, addressed by using a randomized design; b) single-nutrient approaches, by randomizing an overall dietary pattern; and c) the limitations of assessing only intermediate risk markers, by using hard clinical end-points.
publishDate 2017
dc.date.none.fl_str_mv 2017
2018
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/35066
http://dx.doi.org/10.1016/j.numecd.2017.05.004
url http://hdl.handle.net/10230/35066
http://dx.doi.org/10.1016/j.numecd.2017.05.004
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Nutrition, Metabolism & Cardiovascular Diseases. 2017 Jul;27(7):624-32
info:eu-repo/grantAgreement/ES/3PN/AGL-2009-13906-C02
info:eu-repo/grantAgreement/ES/3PN/AGL-2010-22319-C03
dc.rights.none.fl_str_mv © Elsevier http://dx.doi.org/10.1016/j.numecd.2017.05.004
info:eu-repo/semantics/openAccess
rights_invalid_str_mv © Elsevier http://dx.doi.org/10.1016/j.numecd.2017.05.004
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling The PREDIMED trial, Mediterranean diet and health outcomes: How strong is the evidence?Guasch Ferré, MartaSalas-Salvadó, JordiRos, EmilioEstruch, RamónCorella, DoloresFitó Colomer, MontserratMartínez-González, Miguel Ángel, 1957-PREDIMED investigatorsDieta mediterràniaCardiovascular diseaseClinical trialMediterranean dietPREDIMEDAIMS: To address potential controversies on the health benefits of the Mediterranean diet (MedDiet) after PREDIMED, a randomized trial of MedDiet for primary cardiovascular prevention. We have focused on: a) the PREDIMED study design, b) analysis of PREDIMED data and c) interpretation of its results. DATA SYNTHESIS: Regarding the design of the trial, its early termination and between-group differences in the intensity of the intervention are potential causes of concern. The planned duration was 6 years but the trial was prematurely stopped when an interim analysis at 4.8-year provided sufficient evidence of benefit for the two MedDiets. In the MedDiet groups supplemented with extra-virgin olive oil or mixed-nuts, the primary composite endpoint (myocardial infarction, stroke, or cardiovascular death) was reduced by 30% and 28% respectively, as compared with the control group. Final results did not change after taking into account the different intensity of educational efforts during the trial. Other potential doubts related to data analysis (e.g., intention to treat versus a per-protocol approach, and consequences of dropouts) should not be causes of concern. Finally, we addressed alternative interpretations of the effect on all-cause mortality. The protocol-defined primary endpoint was a composite cardiovascular endpoint, not all-cause mortality. To analyze total mortality, we would have needed a much larger sample size and longer follow-up. Therefore, the PREDIMED results cannot be used to draw firm conclusions on MedDiets and all-cause mortality. CONCLUSIONS: The PREDIMED study was designed to overcome three major problems of previous nutritional research: a) residual confounding, addressed by using a randomized design; b) single-nutrient approaches, by randomizing an overall dietary pattern; and c) the limitations of assessing only intermediate risk markers, by using hard clinical end-points.Supported by the official funding agency for biomedical research of the Spanish government, Instituto de Salud Carlos III (ISCIII), through grants provided to research net-works specifically developed for the trial (RTIC G03/140(2003e2005), to Dr. Estruch; RTIC RD 06/0045(2006e2013), to Dr. Martínez González and through Centrode Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición [CIBERobn]), and by grants from Centro Nacional de Investigaciones Cardiovasculares (CNIC06/2007), Fondo de Investigación Sanitaria de Fondo Europeo de Desarrollo Regional (PI04-2239, PI 05/2584, CP06/00100,PI07/0240, PI07/1138, PI07/0954, PI 07/0473, PI10/01407,PI10/02658, PI11/01647, and P11/02505), Ministerio de Ciencia e Innovación (AGL-2009-1390 6-C02 and AGL2010-22319-C03), Fundación Mapfre 2010, Consejería de Salud de la Junta de Andalucía (PI0105/2007), Public Health Divisionof the Department of Health of the Autonomous Government of Catalonia, Generalitat Valenciana (ACOMP06109,GVACOMP2010-181, GVACOMP2011-151, CS2010-AP-111 and CS2011 AP-042), and Regional Government of Navarra(P27/2011). Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundationon Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foun-dation for Alcohol Research (ERAB); receiving lecture fees from Cerveceros de España and Sanofi Aventis; andreceiving grant support through his institution fromNovartis. Dr. Ros reports serving on the board of andreceiving travel support, as well as grant support throughhis institution, from the California Walnut Commission; serving on the board of the Flora Foundation (Unilever);serving on the board of and receiving lecture fees from Roche; serving on the board of and receiving grant support through his institution from Amgen; receiving consulting fees from Damm and Abbott Laboratories; receiving consulting fees and lecture fees, as well as grant support through his institution, from Merck; receiving lecture fees from Danone, Pace, AstraZeneca, and Rottapharm; receiving lecture fees and payment for the development of educational presentations, as well as grant support through his institution, from Ferrer; receiving payment for the devel-opment of educational presentations from Recordati; and receiving grant support through his institution from Sanofi-Aventis, Takeda, Daiichi Sankyo, Nutrexpa, Feiraco, Unilever,and Karo Bio. Dr. Salas-Salvadó reports serving on the boardof and receiving grant support through his institution fromthe International Nut and Dried Fruit Council; receiving consulting fees from Danone; and receiving grant support through his institution from Eroski and Nestlé. No other potential conflict of interest relevant to this article was reported.Elsevier20182017info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/35066http://dx.doi.org/10.1016/j.numecd.2017.05.004reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésNutrition, Metabolism & Cardiovascular Diseases. 2017 Jul;27(7):624-32info:eu-repo/grantAgreement/ES/3PN/AGL-2009-13906-C02info:eu-repo/grantAgreement/ES/3PN/AGL-2010-22319-C03© Elsevier http://dx.doi.org/10.1016/j.numecd.2017.05.004info:eu-repo/semantics/openAccessoai:recercat.cat:10230/350662026-05-29T05:05:01Z
score 15,811543

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