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Prediction of Cardiovascular Disease by the Framingham-REGICOR Equation in the High-Risk PREDIMED Cohort: Impact of the Mediterranean Diet Across Different Risk Strata.
Amor, AJ, Serra-Mir, M, Martínez-González, MA, Corella, D, Salas-Salvadó, J, Fitó, M, Estruch, R, Serra-Majem, L, Arós, F, Babio, N, et al
Journal of the American Heart Association. 2017;(3)
Abstract
BACKGROUND The usefulness of cardiovascular disease (CVD) predictive equations in different populations is debatable. We assessed the efficacy of the Framingham-REGICOR scale, validated for the Spanish population, to identify future CVD in participants, who were predefined as being at high-risk in the PREvención con DIeta MEDiterránea (PREDIMED) study-a nutrition-intervention primary prevention trial-and the impact of adherence to the Mediterranean diet on CVD across risk categories. METHODS AND RESULTS In a post hoc analysis, we assessed the CVD predictive value of baseline estimated risk in 5966 PREDIMED participants (aged 55-74 years, 57% women; 48% with type 2 diabetes mellitus). Major CVD events, the primary PREDIMED end point, were an aggregate of myocardial infarction, stroke, and cardiovascular death. Multivariate-adjusted Cox regression was used to calculate hazard ratios for major CVD events and effect modification from the Mediterranean diet intervention across risk strata (low, moderate, high, very high). The Framingham-REGICOR classification of PREDIMED participants was 25.1% low risk, 44.5% moderate risk, and 30.4% high or very high risk. During 6-year follow-up, 188 major CVD events occurred. Hazard ratios for major CVD events increased in parallel with estimated risk (2.68, 4.24, and 6.60 for moderate, high, and very high risk), particularly in men (7.60, 13.16, and 15.85, respectively, versus 2.16, 2.28, and 3.51, respectively, in women). Yet among those with low or moderate risk, 32.2% and 74.3% of major CVD events occurred in men and women, respectively. Mediterranean diet adherence was associated with CVD risk reduction regardless of risk strata (P>0.4 for interaction). CONCLUSIONS Incident CVD increased in parallel with estimated risk in the PREDIMED cohort, but most events occurred in non-high-risk categories, particularly in women. Until predictive tools are improved, promotion of the Mediterranean diet might be useful to reduce CVD independent of baseline risk. CLINICAL TRIAL REGISTRATION URL: http://www.Controlled-trials.com. Unique identifier: ISRCTN35739639.
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Does the Mediterranean diet counteract the adverse effects of abdominal adiposity?
Eguaras, S, Toledo, E, Buil-Cosiales, P, Salas-Salvadó, J, Corella, D, Gutierrez-Bedmar, M, Santos-Lozano, JM, Arós, F, Fiol, M, Fitó, M, et al
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2015;(6):569-74
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BACKGROUND AND AIM We tested the hypothesis that an intervention with a Mediterranean diet (MeDiet) could mitigate the well-known harmful effects of abdominal obesity on cardiovascular health. METHODS AND RESULTS We assessed the relationship between baseline waist-to-height ratio (WHtR) and major cardiovascular events during a median follow-up of 4.8 years in the Prevention with Mediterranean Diet (PREDIMED) randomized primary prevention trial, which tested a MeDiet against a control diet (advice on a low-fat diet). We also examined whether the MeDiet intervention was able to counteract the detrimental cardiovascular effects of an increased WHtR. The trial included 7447 participants (55-80 years old, 57% women) at high cardiovascular risk but free of cardiovascular disease (CVD) at enrollment. An increased risk of CVD events (myocardial infarction, stroke, or cardiovascular death) was apparent for the highest versus the lowest quartile of WHtR (multivariable-adjusted hazard ratio: 1.98) (95% confidence interval: 1.10-3.57; linear trend: p = 0.019) only in the control-diet group, but not in the two groups allocated to intervention with MeDiet (p for interaction = 0.034). This apparent interaction suggesting that the intervention counterbalanced the detrimental cardiovascular effects of adiposity was also significant for body mass index (BMI) (p = 0.01) and waist circumference (p = 0.043). CONCLUSIONS The MeDiet may counteract the harmful effects of increased adiposity on the risk of CVD.
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Benefits of the Mediterranean Diet: Insights From the PREDIMED Study.
Martínez-González, MA, Salas-Salvadó, J, Estruch, R, Corella, D, Fitó, M, Ros, E, ,
Progress in cardiovascular diseases. 2015;(1):50-60
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The PREDIMED (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial assessed the long-term effects of the Mediterranean diet (MeDiet) on clinical events of cardiovascular disease (CVD). We randomized 7447 men and women at high CVD risk into three diets: MeDiet supplemented with extra-virgin olive oil (EVOO), MeDiet supplemented with nuts, and control diet (advice on a low-fat diet). No energy restriction and no special intervention on physical activity were applied. We observed 288 CVD events (a composite of myocardial infarction, stroke or CVD death) during a median time of 4.8years; hazard ratios were 0.70 (95% CI, 0.53-0.91) for the MeDiet+EVOO and 0.70 (CI, 0.53-0.94) for the MeDiet+nuts compared to the control group. Respective hazard ratios for incident diabetes (273 cases) among 3541 non-diabetic participants were 0.60 (0.43-0.85) and 0.82 (0.61-1.10) for MeDiet+EVOO and MeDiet+nuts, respectively versus control. Significant improvements in classical and emerging CVD risk factors also supported a favorable effect of both MeDiets on blood pressure, insulin sensitivity, lipid profiles, lipoprotein particles, inflammation, oxidative stress, and carotid atherosclerosis. In nutrigenomic studies beneficial effects of the intervention with MedDiets showed interactions with several genetic variants (TCF7L2, APOA2, MLXIPL, LPL, FTO, M4CR, COX-2, GCKR and SERPINE1) with respect to intermediate and final phenotypes. Thus, the PREDIMED trial provided strong evidence that a vegetable-based MeDiet rich in unsaturated fat and polyphenols can be a sustainable and ideal model for CVD prevention.
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Baseline adherence to the Mediterranean diet and major cardiovascular events: Prevención con Dieta Mediterránea trial.
Schröder, H, Salas-Salvadó, J, Martínez-González, MA, Fíto, M, Corella, D, Estruch, R, Ros, E
JAMA internal medicine. 2014;(10):1690-2
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Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial.
Toledo, E, Hu, FB, Estruch, R, Buil-Cosiales, P, Corella, D, Salas-Salvadó, J, Covas, MI, Arós, F, Gómez-Gracia, E, Fiol, M, et al
BMC medicine. 2013;:207
Abstract
BACKGROUND Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. METHODS The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular disease. Participants were assigned to a control group or to one of two Mediterranean diets. The control group received education on following a low-fat diet, while the groups on Mediterranean diets received nutritional education and also free foods; either extra virgin olive oil, or nuts. Trained personnel measured participants' BP at baseline and once yearly during a 4-year follow-up. We used generalized estimating equations to assess the differences between groups during the follow-up. RESULTS The percentage of participants with controlled BP increased in all three intervention groups (P-value for within-group changes: P<0.001). Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group (-1.53 mmHg (95% confidence interval (CI) -2.01 to -1.04) for the Mediterranean diet supplemented with extra virgin olive oil, and -0.65 mmHg (95% CI -1.15 to -0.15) mmHg for the Mediterranean diet supplemented with nuts). No between-group differences in changes of systolic BP were seen. CONCLUSIONS Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP. However, we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group. TRIAL REGISTRATION Current Controlled Trials ISRCTN35739639.