Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial
- PMID: 35525255
- DOI: 10.1016/S0140-6736(22)00122-2
Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial
Abstract
Background: Mediterranean and low-fat diets are effective in the primary prevention of cardiovascular disease. We did a long-term randomised trial to compare the effects of these two diets in secondary prevention of cardiovascular disease.
Methods: The CORDIOPREV study was a single-centre, randomised clinical trial done at the Reina Sofia University Hospital in Córdoba, Spain. Patients with established coronary heart disease (aged 20-75 years) were randomly assigned in a 1:1 ratio by the Andalusian School of Public Health to receive a Mediterranean diet or a low-fat diet intervention, with a follow-up of 7 years. Clinical investigators (physicians, investigators, and clinical endpoint committee members) were masked to treatment assignment; participants were not. A team of dietitians did the dietary interventions. The primary outcome (assessed by intention to treat) was a composite of major cardiovascular events, including myocardial infarction, revascularisation, ischaemic stroke, peripheral artery disease, and cardiovascular death. This study is registered with ClinicalTrials.gov, NCT00924937.
Findings: From Oct 1, 2009, to Feb 28, 2012, a total of 1002 patients were enrolled, 500 (49·9%) in the low-fat diet group and 502 (50·1%) in the Mediterranean diet group. The mean age was 59·5 years (SD 8·7) and 827 (82·5%) of 1002 patients were men. The primary endpoint occurred in 198 participants: 87 in the Mediterranean diet group and 111 in the low-fat group (crude rate per 1000 person-years: 28·1 [95% CI 27·9-28·3] in the Mediterranean diet group vs 37·7 [37·5-37·9] in the low-fat group, log-rank p=0·039). Multivariable-adjusted hazard ratios (HRs) of the different models ranged from 0·719 (95% CI 0·541-0·957) to 0·753 (0·568-0·998) in favour of the Mediterranean diet. These effects were more evident in men, with primary endpoints occurring in 67 (16·2%) of 414 men in the Mediterranean diet group versus 94 (22·8%) of 413 men in the low-fat diet group (multiadjusted HR 0·669 [95% CI 0·489-0·915], log-rank p=0·013), than in 175 women for whom no difference was found between groups.
Interpretation: In secondary prevention, the Mediterranean diet was superior to the low-fat diet in preventing major cardiovascular events. Our results are relevant to clinical practice, supporting the use of the Mediterranean diet in secondary prevention.
Funding: Fundacion Patrimonio Comunal Olivarero; Fundacion Centro para la Excelencia en Investigacion sobre Aceite de Oliva y Salud; local, regional, and national Spanish Governments; European Union.
Copyright © 2022 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Declaration of interests JD-L reports a research grant from Instituto de Salud Carlos III (PI13/00023) and has received fees for lectures and educational activities from Novo-Nordisk, Amgen, Laboratorios Dr Esteve, Ferrer, Servier, Mylan–Viatrix, Instituto Cervantes, and the Spanish Society of Internal Medicine, all unrelated to this work. JFA-D reports research grants from Servicio Andaluz de Salud (B-0009-2017) and Insituto de Salud Carlos III (CM12/00202), and has received fees for lectures and educational activities from Bayer, Grunenthal Pharma, Laboratorios Dr Esteve, Ferrer, and Boehringer Ingelheim, all unrelated to this work. JDT-P has received fees for lectures and educational activities from Laboratorios Dr Esteve, Amgen, Sanofi, and the Spanish Society of Internal Medicine, all unrelated to this work, and is a board member of the Andalusian Society of Internal Medicine. FF has received fees for lectures and educational activities from Laboratorios Dr Esteve, Mylan, Novartis, Menarini, Servier, Novo-Nordisk, and Amgen, all unrelated to this work. AG-R reports a research grant from Consejería de Salud Junta de Andalucía (PI-0206-2013) and has received fees for lectures and educational activities from Laboratorios Dr Esteve and Instituto Cervantes, all unrelated to this work. EMY-S reports grants from Consejería de Salud-Junta de Andalucía (PC-0283-2017), Carlos III Health Institute (PI18/01822), and Servicio Andaluz de Salud-Junta de Andalucia (Nicolas Monardes Programme Contract C1-0005-2019). OAR-Z reports research grants from Ministerio de Ciencia e Innovacion (PI15/00733), Fundación para la investigación Biomédica de Córdoba (PI-0170-2018-FIB), and de Instituto de salud Carlos III (Miguel Servet Program CP19/00142). AC reports research grants from Instituto de Salud Carlos III (CP14/00114, PI19/00299, and DTS19/00007) and Ministerio de Economía y Competitividad (AGL2015-67896-P). FL-S has received fees for lectures and educational activities from Pfizer, Novartis, Mylan–Viatris, and Boehringer Ingelheim, all unrelated to this work. LB reports a research grant from AstraZeneca, has served on scientific advisory boards of Sanofi, Bayer, and AstraZeneca, has received speaker fees from Lilly, MSD–Boehringer, and AstraZeneca, and founded the spin-offs for Glycardial Diagnostics and Ivastatin Therapeutics S, all unrelated to this work. JMO has received research funding from the US Department of Agriculture on personalised nutrition, and from Archer Daniels Midland on probiotics, has served on the scientific advisory board or as a consultant for Nutrigenomix, the Predict Study, General Nutrition Centres, Weight Watchers, Metagenics, and Reckitt Group, all unrelated to this work. FP-J reports research grants from Instituto de Salud Carlos III (PI10/02412 and PI13/00619) and has received fees for lectures and educational activities from Mylan and Instituto Cervantes, unrelated to this work. PP-M reports research grants from Instituto de Salud Carlos III (PI13/00185, PI10/01041, and PI16/01777) and Consejería Salud Junta de Andalucía (PI058/10), and has received fees for lectures and educational activities for Novo-Nordisk, Boehringer Ingelheim, Amgen, Laboratorios Dr Esteve, MSD, Ferrer, Menarini, Servier, Mylan–Viatrix, Instituto Cervantes, and the Spanish Society of Internal Medicine, all unrelated to this work. JL-M reports research grants from Instituto de Salud Carlos III (PIE14/00005 and PIE14/00005), Ministerio de Ciencia e Innovación (PID2019-104362RB-I00, AGL2009-122270, PCIN-2016-084, and AGL2012/39615), Consejería de Salud Junta de Andalucia (PI0193/09), Ministerio de Ciencia e Innovación (AGL2015-67896-P), and Consejería de Economía, Innovación, Ciencia y Empleo (P20_00256 and CVI-7450), has received fees for lectures and educational activities from Novo-Nordisk, Sanofi, Amgen, Laboratorios Dr Esteve, MSD, and Instituto Cervantes, and has received consulting fees from Amgen and Sanofi, all unrelated to this work. All other authors declare no competing interests.
Comment in
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Mediterranean diet superior to low-fat diet for secondary prevention of CVD.Nat Rev Cardiol. 2022 Jul;19(7):432. doi: 10.1038/s41569-022-00727-4. Nat Rev Cardiol. 2022. PMID: 35624289 No abstract available.
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In patients with CHD, a Mediterranean vs. low-fat diet reduced major CV events at 7 y.Ann Intern Med. 2022 Sep;175(9):JC100. doi: 10.7326/J22-0061. Epub 2022 Sep 6. Ann Intern Med. 2022. PMID: 36063545
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