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Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial. Eur J Heart Fail 2017; 19 :1179–1185. doi: 10.1002/ejhf.750

2019; Elsevier BV; Volume: 21; Issue: 3 Linguagem: Inglês

10.1002/ejhf.1346

1879-0844

Angeliki Papadaki, Miguel Ángel Martínez‐González, Ángel M. Alonso‐Gómez, Javier Rekondo, Jordi Salas‐Salvadó, Dolores Corella, Emilio Ros, Montserrat Fitó, Ramón Estruch, José Lapetra, Antonio García‐Rodríguez, Miquel Fiol, Lluís Serra‐Majem, Xavier Pintó, Miguel Ruiz‐Canela, Mònica Bulló, Mercè Serra‐Mir, José V. Sorlí, Fernando Arós,

Diet and metabolism studies

European Journal of Heart FailureVolume 21, Issue 3 p. 389-391 ErratumFree Access Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial. Eur J Heart Fail 2017;19:1179–1185. doi: 10.1002/ejhf.750 This article corrects the following: Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial Angeliki Papadaki, Miguel Ángel Martínez-González, Angel Alonso-Gómez, Javier Rekondo, Jordi Salas-Salvadó, Dolores Corella, Emilio Ros, Montse Fitó, Ramon Estruch, José Lapetra, Antonio García-Rodriguez, Miquel Fiol, Lluís Serra-Majem, Xavier Pintó, Miguel Ruiz-Canela, Monica Bulló, Mercè Serra-Mir, Jose V. Sorlí, Fernando Arós, Volume 19Issue 9European Journal of Heart Failure pages: 1179-1185 First Published online: January 30, 2017 Angeliki Papadaki, Angeliki PapadakiSearch for more papers by this authorMiguel Ángel Martínez-González, Miguel Ángel Martínez-GonzálezSearch for more papers by this authorAngel Alonso-Gómez, Angel Alonso-GómezSearch for more papers by this authorJavier Rekondo, Javier RekondoSearch for more papers by this authorJordi Salas-Salvadó, Jordi Salas-SalvadóSearch for more papers by this authorDolores Corella, Dolores CorellaSearch for more papers by this authorEmilio Ros, Emilio RosSearch for more papers by this authorMontse Fitó, Montse FitóSearch for more papers by this authorRamon Estruch, Ramon EstruchSearch for more papers by this authorJosé Lapetra, José LapetraSearch for more papers by this authorAntonio García-Rodriguez, Antonio García-RodriguezSearch for more papers by this authorMiquel Fiol, Miquel FiolSearch for more papers by this authorLluís Serra-Majem, Lluís Serra-MajemSearch for more papers by this authorXavier Pintó, Xavier PintóSearch for more papers by this authorMiguel Ruiz-Canela, Miguel Ruiz-CanelaSearch for more papers by this authorMonica Bulló, Monica BullóSearch for more papers by this authorMercè Serra-Mir, Mercè Serra-MirSearch for more papers by this authorJose V. Sorlí, Jose V. SorlíSearch for more papers by this authorFernando Arós, Fernando ArósSearch for more papers by this author Angeliki Papadaki, Angeliki PapadakiSearch for more papers by this authorMiguel Ángel Martínez-González, Miguel Ángel Martínez-GonzálezSearch for more papers by this authorAngel Alonso-Gómez, Angel Alonso-GómezSearch for more papers by this authorJavier Rekondo, Javier RekondoSearch for more papers by this authorJordi Salas-Salvadó, Jordi Salas-SalvadóSearch for more papers by this authorDolores Corella, Dolores CorellaSearch for more papers by this authorEmilio Ros, Emilio RosSearch for more papers by this authorMontse Fitó, Montse FitóSearch for more papers by this authorRamon Estruch, Ramon EstruchSearch for more papers by this authorJosé Lapetra, José LapetraSearch for more papers by this authorAntonio García-Rodriguez, Antonio García-RodriguezSearch for more papers by this authorMiquel Fiol, Miquel FiolSearch for more papers by this authorLluís Serra-Majem, Lluís Serra-MajemSearch for more papers by this authorXavier Pintó, Xavier PintóSearch for more papers by this authorMiguel Ruiz-Canela, Miguel Ruiz-CanelaSearch for more papers by this authorMonica Bulló, Monica BullóSearch for more papers by this authorMercè Serra-Mir, Mercè Serra-MirSearch for more papers by this authorJose V. Sorlí, Jose V. SorlíSearch for more papers by this authorFernando Arós, Fernando ArósSearch for more papers by this author First published: 30 January 2019 https://doi.org/10.1002/ejhf.1346Citations: 4AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Some departures from the individual randomization protocol affecting a small subset of participants in the PREvención con DIeta MEDiterránea (PREDIMED) trial (at most 14%) have recently been reported in the re-publication of the main PREDIMED paper.1 For this reason, the authors wish to make the following clarifications and corrections to their original PREDIMED sub-study examining the effect of the Mediterranean diets (MedDiets), supplemented with extra-virgin olive oil (EVOO) or nuts, on the risk of heart failure.2 In the original sub-study, as reported in detail elsewhere,1 some participants (n = 425, or 5.7% of the total sample) were directly allocated, since they were recruited, to the same arm of the trial as their relatives because a previous member of the same household (usually the spouse) was already randomized in the trial. Also, centre D, one of the 11 recruiting centres (n = 646, or 8.7% of the total sample), had allocated a subset of its participants by clusters (clinics), instead of using individual randomization (35 participants from centre D were also second household members). The authors have re-analysed the effect of the intervention on the incidence of heart failure after adjusting for propensity scores (built with 30 predictors of allocation to each intervention group) and using a robust estimate of the variance to correct for intra-cluster correlation, considering the members of the same household and the participants in the same clinics of centre D as clusters. The corrected Table 2 and Figure 1 (see below; all corrections are marked in bold characters) show the corrected estimates for the outcome, as compared with those reported in the original paper. In consistency with the published paper,2 the unadjusted hazard ratios (HR) did not indicate significant associations for the MedDiet + EVOO [HR 0.63; 95% confidence interval (CI) 0.38–1.04] and MedDiet + nuts (HR 0.91; 95% CI 0.55–1.50), compared with the control group. Results from the multivariate analyses (Table 2) also remained unchanged. Table 2. Incidence of heart failure during the trial period with active intervention (2003–2010) by intervention group Mediterranean diet + EVOO (n = 2527) Mediterranean diet + nuts (n = 2444) Control diet (n = 2432) P-value Mediterraneandiet + EVOO vs. control Mediterranean diet + nuts vs. control Cases (n = 94) 29 33 32 Person-years of follow-up 11 737 10 279 9664 Crude rate/1000 person-years (95% CI) 2.5 (1.7–3.5) 3.2 (2.2–4.5) 3.3 (2.3–4.7) Original hazard ratios (95% CI) New hazard ratios (95% CI) Crude model* 0.68 (0.41–1.13) 0.92 (0.56–1.49) 1 (ref.) 0.139 0.725 Crude model†,a 0.63 (0.38–1.04) 0.91 (0.55–1.50) 1 (ref) 0.068 0.706 Age- and sex-adjusted model* 0.71 (0.43–1.19) 0.98 (0.60–1.61) 1 (ref.) 0.193 0.943 Age- and sex-adjusted model†,a 0.66 (0.40–1.09) 0.99 (0.60–1.63) 1 (ref) 0.104 0.961 Multivariate adjusted model 1*,b 0.77 (0.46–1.28) 1.04 (0.64–1.71) 1 (ref.) 0.312 0.864 Multivariate adjusted model 1‡,c 0.76 (0.46–1.28) 1.16 (0.70–1.93) 1 (ref) 0.303 0.559 Multivariate adjusted model 2*,d 0.78 (0.46–1.30) 1.07 (0.65–1.76) 1(ref.) 0.336 0.792 Multivariate adjusted model 2‡,e 0.77 (0.46–1.28) 1.18 (0.71–1.95) 1 (ref) 0.310 0.527 Multivariate adjusted model 3*,f 0.74 (0.44–1.24) 1.01 (0.61–1.66) 1(ref.) 0.248 0.981 Multivariate adjusted model 3‡,g 0.73 (0.43–1.24) 1.12 (0.67–1.87) 1 (ref) 0.244 0.659 Excluding centre D and second members of the same household Cases (n = 74) 18 29 27 Person-years of follow-up 9819 8921 8536 Crude rate/1000 person-years (95% CI) 1.8 (1.2–2.9) 3.3 (2.3–4.7) 3.2 (2.2–4.6) Multivariate adjusted model 3‡,g 0.66 (0.35-1.25) 1.18 (0.68-2.04) 1 (ref) 0.205 0.558 CI, confidence interval; EVOO, extra-virgin olive oil. * Models were stratified according to centre and history of diabetes and used robust variance estimators. † Models were stratified according to centre and history of diabetes. ‡ Models were stratified according to centre, sex and education (four categories). a Models used robust estimate of the variance adjusted for intra-cluster correlation, considering the members of the same household and the participants in the same clinics of centre D as clusters. b Adjusted for age, sex, education (four categories), smoking (three categories), waist-to-height ratio (continuous), physical activity (METS-min/d), dyspnea symptoms at baseline (three categories) and non-AF arrhythmias at baseline. c Adjusted for age, smoking (three categories), waist-to-height ratio (continuous), physical activity (METS-min/day), dyspnoea symptoms at baseline (three categories), non-atrial fibrillation arrhythmias at baseline and history of diabetes. Models used robust estimates of the variance adjusted for propensity scores and intra-cluster correlation, considering the members of the same household and the participants in the same clinics of centre D as clusters. d Adjusted for (b), history of hypertension, history of dyslipidaemia, family history of premature coronary heart disease and baseline prevalence of atrial fibrillation. e Adjusted for (c) and history of hypertension, history of dyslipidaemia, family history of premature coronary heart disease and baseline prevalence of atrial fibrillation. Models used robust estimates of the variance adjusted for propensity scores and intra-cluster correlation, considering the members of the same household and the participants in the same clinics of centre D as clusters. f Adjusted for (d) and baseline energy intake (kcal/day). g Adjusted for (e) and baseline energy intake (kcal/day). Models used robust estimates of the variance adjusted for propensity scores and intra-cluster correlation, considering the members of the same household and the participants in the same clinics of centre D as clusters. Figure 1Open in figure viewerPowerPoint Kaplan–Meier estimates of the incidence of heart failure in the total study population (trial intervention period, 2003–2010). Hazard ratios were stratified by centre and history of diabetes (Cox model with robust estimates for the variance, adjusted for propensity scores and intra-cluster correlation, considering the members of the same household and the participants in the same clinics of centre D as clusters). CI, confidence interval; EVOO; extra-virgin olive oil; MedDiet, Mediterranean diet. As a sensitivity analysis, we also re-analysed the data after excluding participants from centre D and those who were members of the same household (Table 2). The new multivariate adjusted HRs for heart failure were 0.66 (95% CI 0.35–1.25) and 1.18 (95% CI 0.68–2.04) for the MedDiet + EVOO and the MedDiet + nuts groups, respectively, compared with the control group. Importantly, the key message from the original article does not change and the final conclusions remain the same. References 1Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Fitó M, Gea A, Hernán MA, Martínez-González MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. N Engl J Med 2018; 378: e34. 2Papadaki A, Martinez-Gonzalez MA, Alonso-Gomez A, Rekondo J, Salas-Salvadó J, Corella D, Ros E, Fitó M, Estruch R, Lapetra J, García-Rodriguez A, Fiol M, Serra-Majem L, Pintó X, Ruiz-Canela M, Bulló M, Serra-Mir M, Sorlí JV, Arós F. Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial. Eur J Heart Fail 2017; 19: 1179– 1185. Citing Literature Volume21, Issue3March 2019Pages 389-391 FiguresReferencesRelatedInformation