补充特级初榨橄榄油或坚果的地中海饮食对心血管疾病的一级预防
Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts.
作者信息
Estruch Ramón, Ros Emilio, Salas-Salvadó Jordi, Covas Maria-Isabel, Corella Dolores, Arós Fernando, Gómez-Gracia Enrique, Ruiz-Gutiérrez Valentina, Fiol Miquel, Lapetra José, Lamuela-Raventos Rosa M, Serra-Majem Lluís, Pintó Xavier, Basora Josep, Muñoz Miguel A, Sorlí José V, Martínez J Alfredo, Fitó Montserrat, Gea Alfredo, Hernán Miguel A, Martínez-González Miguel A
机构信息
From the PREDIMED (Prevención con Dieta Mediterránea) Network (RD 06/0045) (R.E., J.S.-S., F.A., E.G.-G., V.R.-G., R.M.L.-R., L.S.-M., X.P., J.B., J.V.S., J.A.M., M.A.M.-G.) and Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (R.E., E.R., J.S.-S., M.-I.C., D.C., F.A., M. Fiol, J.L., R.M.L.-R., L.S.-M., X.P., J.B., J.V.S., J.A.M., M. Fitó, A.G., M.A.M.-G.), Instituto de Salud Carlos III, Madrid, the Department of Internal Medicine, Hospital Clinic (R.E.), the Lipid Clinic, Department of Endocrinology and Nutrition, Institut d'Investigacions Biomèdiques August Pi i Sunyer (E.R.), and the Department of Nutrition, Food Sciences, and Gastronomy, Faculty of Pharmacy and Food Sciences, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Nutrición y Seguridad Alimentaria (R.M.L.-R.), University of Barcelona, Institut Hospital del Mar d'Investigacions Mèdiques (M.-I.C., M. Fitó), the Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat (X.P.), and the Primary Care Division, Catalan Institute of Health, Institut Universitari d'Investigació en Atenció Primària (IDIAP)-Jordi Gol (M.A.M.), Barcelona, the Human Nutrition Department, Hospital Universitari Sant Joan, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Reus (J.S.-S.), the Department of Preventive Medicine, University of Valencia (D.C., J.V.S.), and the Primary Care Division, Valencia Institute of Health (J.V.S.), Valencia, the Department of Cardiology, University Hospital of Álava, Vitoria (F.A.), the Department of Preventive Medicine, University of Malaga, Malaga (E.G.-G.), Instituto de la Grasa, Consejo Superior de Investigaciones Científicas (V.R.-G.), and the Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center (J.L.), Seville, the Institute of Health Sciences, University of the Balearic Islands, and Hospital Son Espases, Palma de Mallorca (M. Fiol), the Research Institute of Biomedical and Health Sciences, Instituto Universitario de Investigaciones Biomédicas y Sanitarias, University of Las Palmas de Gran Canaria, Las Palmas (L.S.-M.), the Primary Care Division, Catalan Institute of Health, IDIAP-Jordi Gol, Tarragona-Reus (J.B.), and the Departments of Nutrition and Food Sciences and Physiology (J.A.M.) and Preventive Medicine and Public Health (A.G., M.A.M.-G.), University of Navarra, Pamplona - all in Spain; and the Departments of Epidemiology and Biostatistics (M.A.H.) and Nutrition (M.A.M.-G.), Harvard T.H. Chan School of Public Health, and the Harvard-MIT Division of Health Sciences and Technology (M.A.H.), Boston.
出版信息
N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
BACKGROUND
Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk.
METHODS
In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) 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 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 a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned.
RESULTS
A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol.
CONCLUSIONS
In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).
背景
观察性队列研究和一项二级预防试验表明，坚持地中海饮食与心血管疾病风险呈负相关。
方法
在西班牙的一项多中心试验中，我们将7447名心血管疾病风险高但入组时无心血管疾病的参与者（年龄55至80岁，57%为女性）随机分配至三种饮食方案之一：补充特级初榨橄榄油的地中海饮食、补充混合坚果的地中海饮食或对照饮食（建议减少膳食脂肪）。参与者每季度接受一次教育课程，并根据分组情况免费提供特级初榨橄榄油、混合坚果或小的非食品礼物。主要终点是重大心血管事件（心肌梗死、中风或心血管疾病导致的死亡）。在中位随访4.8年后，基于预先设定的中期分析停止了试验。2013年，我们在《期刊》上报告了主要终点的结果。随后，我们发现了方案偏差，包括未随机分组就纳入家庭成员、在11个研究地点中的1个地点部分参与者未随机分组就被分配到研究组，以及另一个地点随机分组表的使用明显不一致。我们撤回了之前发表的报告，现在报告基于不单纯依赖所有参与者均被随机分配这一假设的分析得出的修正效应估计值。
结果
288名参与者发生了主要终点事件；补充特级初榨橄榄油的地中海饮食组有96例事件（3.8%），补充坚果的地中海饮食组有83例事件（3.4%），对照组有109例事件（4.4%）。在包括所有参与者并对基线特征和倾向得分进行调整的意向性分析中，与对照饮食相比，补充特级初榨橄榄油的地中海饮食的风险比为0.69（95%置信区间[CI]，0.53至0.91），补充坚果的地中海饮食的风险比为0.72（95%CI，0.54至0.95）。在排除1588名研究组分配已知或疑似偏离方案的参与者后，结果相似。
结论
在这项涉及心血管疾病风险高的人群的研究中，分配到补充特级初榨橄榄油或坚果的地中海饮食组的参与者中，重大心血管事件的发生率低于分配到低脂饮食组的参与者。（由西班牙卫生部卡洛斯三世卫生研究所等资助；当前受控试验编号，ISRCTN35739639。）
Zotero 插件