Delgado-Lista Javier, Alcala-Diaz Juan F, Torres-Peña Jose D, Quintana-Navarro Gracia M, Fuentes Francisco, Garcia-Rios Antonio, Ortiz-Morales Ana M, Gonzalez-Requero Ana I, Perez-Caballero Ana I, Yubero-Serrano Elena M, Rangel-Zuñiga Oriol A, Camargo Antonio, Rodriguez-Cantalejo Fernando, Lopez-Segura Fernando, Badimon Lina, Ordovas Jose M, Perez-Jimenez Francisco, Perez-Martinez Pablo, Lopez-Miranda Jose
Lipids and Atherosclerosis Unit, Department of Internal Medicine, Hospital Universitario Reina Sofía, Córdoba, Spain; Department of Medical and Surgical Sciences, Universidad de Córdoba, Córdoba, Spain; Maimonides Institute for Biomedical Research in Córdoba (IMIBIC), Córdoba, Spain; CIBER Fisiopatologia Obesidad y Nutricion (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.
Lipids and Atherosclerosis Unit, Department of Internal Medicine, Hospital Universitario Reina Sofía, Córdoba, Spain; Department of Medical and Surgical Sciences, Universidad de Córdoba, Córdoba, Spain; Maimonides Institute for Biomedical Research in Córdoba (IMIBIC), Córdoba, Spain; CIBER Fisiopatologia Obesidad y Nutricion (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.
Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.
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.
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.
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.
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.
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.
地中海饮食和低脂饮食在心血管疾病的一级预防中有效。我们进行了一项长期随机试验，比较这两种饮食在心血管疾病二级预防中的效果。
CORDIOPREV研究是在西班牙科尔多瓦的雷纳索菲亚大学医院进行的一项单中心随机临床试验。患有确诊冠心病（年龄20 - 75岁）的患者由安达卢西亚公共卫生学院按1:1比例随机分配，接受地中海饮食或低脂饮食干预，随访7年。临床研究人员（医生、研究人员和临床终点委员会成员）对治疗分配情况不知情；参与者知情。一组营养师进行饮食干预。主要结局（按意向性分析评估）是主要心血管事件的复合指标，包括心肌梗死、血运重建、缺血性卒中、外周动脉疾病和心血管死亡。本研究已在ClinicalTrials.gov注册，注册号为NCT00924937。
从2009年10月1日至2012年2月28日，共纳入1002例患者，低脂饮食组500例（49.9%），地中海饮食组502例（50.1%）。平均年龄为59.5岁（标准差8.7），1002例患者中827例（82.5%）为男性。198名参与者发生了主要终点事件：地中海饮食组87例，低脂组111例（每1000人年的粗发病率：地中海饮食组为28.1 [95%可信区间27.9 - 28.3]，低脂组为37.7 [37.5 - 37.9]，对数秩检验p = 0.039）。不同模型的多变量调整风险比（HR）范围为0.719（95%可信区间0.541 - 0.957）至0.753（0.568 - 0.998），支持地中海饮食。这些效果在男性中更明显，地中海饮食组414名男性中有67例（16.2%）发生主要终点事件，而低脂饮食组413名男性中有94例（22.8%）（多因素调整HR 0.669 [95%可信区间0.489 - 0.915]，对数秩检验p = 0.013），而175名女性两组之间未发现差异。
在二级预防中，地中海饮食在预防主要心血管事件方面优于低脂饮食。我们的结果与临床实践相关，支持在二级预防中使用地中海饮食。
奥利韦拉遗产基金会；橄榄油与健康卓越研究中心基金会；西班牙地方、地区和国家政府；欧盟。
