1.
Cardiovascular effects of B-vitamins and/or N-3 fatty acids: the SU.FOL.OM3 trial.
Blacher, J, Czernichow, S, Paillard, F, Ducimetiere, P, Hercberg, S, Galan, P, ,
International journal of cardiology. 2013;(2):508-13
Abstract
BACKGROUND Mechanisms involved in coronary stenosis evolution are different than those involved in clinical events. Because of differential vascular effects, N-3 polyunsatured fatty acids (PUFA) and B vitamins could have differential effects on different types of cardiovascular clinical events in high-risk patients. METHODS We analyzed the effects of n-3 PUFA and of B vitamins on both coronary revascularization and on hard coronary events risks in a subgroup of the SU.FOL.OM3 trial, a randomized, double-blind, placebo-controlled secondary prevention trial. Data were analyzed according to the intention-to-treat principle, with the use of Cox proportional-hazards models. RESULTS After a mean follow-up of 4.2 ± 1.0 years among the 1,863 participants with coronary heart disease, 163 coronary revascularizations were performed, and 95 patients experienced a hard coronary event. Neither treatment with n-3 PUFA, nor treatment with B vitamins was associated with any significant effect on the occurrence of hard coronary events. Allocation to n-3 PUFA was not associated with any significant effect on coronary revascularization. However, treatment with B vitamins was associated with a statistically significant 52% increase in the risk of coronary revascularization (multivariate HR: 1.52; 95% CI: [1.11-2.10]; p=0.01). CONCLUSIONS Neither n-3 PUFA, nor B vitamins reduced the rates of hard coronary events and of coronary revascularization. Furthermore, B vitamins significantly increased the rate of coronary revascularization. Consistent with the findings of previous trials, our results do not support the routine use of dietary supplements containing n-3 PUFA and argue against using dietary supplements containing B-vitamins in coronary patients in secondary cardiovascular prevention.
2.
B vitamin and/or ω-3 fatty acid supplementation and cancer: ancillary findings from the supplementation with folate, vitamins B6 and B12, and/or omega-3 fatty acids (SU.FOL.OM3) randomized trial.
Andreeva, VA, Touvier, M, Kesse-Guyot, E, Julia, C, Galan, P, Hercberg, S
Archives of internal medicine. 2012;(7):540-7
Abstract
BACKGROUND To advance knowledge about the cancer-chemopreventive potential of individual nutrients, we investigated the effects of B vitamin and/or ω-3 fatty acid supplements on cancer outcomes among survivors of cardiovascular disease. METHODS This was an ancillary study of the Supplementation With Folate, Vitamins B(6) and B(12) and/or Omega-3 Fatty Acids (SU.FOL.OM3) secondary prevention trial (2003-2009). In all, 2501 individuals aged 45 to 80 years were randomized in a 2 × 2 factorial design to one of the following 4 daily supplementation groups: (1) 5-methyltetrahydrofolate (0.56 mg), pyridoxine hydrochloride (vitamin B(6); 3 mg) and cyanocobalamin (vitamin B(12); 0.02 mg); (2) eicosapentaenoic and docosahexaenoic acid (600 mg) in a 2:1 ratio; (3) B vitamins and ω-3 fatty acids; or (4) placebo. Overall and sex-specific hazard ratios (HRs) and 95% CIs regarding the cancer outcomes were estimated with Cox proportional hazards models. RESULTS After 5 years of supplementation, incident cancer was validated in 7.0% of the sample (145 events in men and 29 in women), and death from cancer occurred in 2.3% of the sample. There was no association between cancer outcomes and supplementation with B vitamins (HR, 1.15 [95% CI, 0.85-1.55]) and/or ω-3 fatty acids (HR, 1.17 [95% CI, 0.87-1.58]). There was a statistically significant interaction of treatment by sex, with no effect of treatment on cancer risk among men and increased cancer risk among women for ω-3 fatty acid supplementation (HR, 3.02 [95% CI, 1.33-6.89]). CONCLUSION We found no beneficial effects of supplementation with relatively low doses of B vitamins and/or ω-3 fatty acids on cancer outcomes in individuals with prior cardiovascular disease. Trial Registration isrctn.org Identifier: ISRCTN41926726.
3.
Control of baseline cardiovascular risk factors in the SU-FOL-OM3 study cohort: does the localization of the arterial event matter?
Vesin, C, Galan, P, Gautier, B, Czernichow, S, Hercberg, S, Blacher, J
European journal of cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology. 2010;(5):541-8
Abstract
AIM AND METHOD No data are currently available on the prevalence and control of cardiovascular (CV) risk factors in secondary prevention depending on the cardiac or cerebral localization of the ischemic disease. We investigated the prevalence and control of modifiable CV risk factors, as well as the determinants of CV risk factors' control and adequate treatment in a secondary prevention cohort, the SU-FOL-OM3 study cohort, to determine the role of the localization of the ischemic disease including events. RESULTS A total of 2491 patients were included in the study. The prevalence of all modifiable risk factors was high in both coronary heart disease and cerebrovascular disease (CVD) groups. Control of all risk factors and the presence of antiplatelet medication were noted in 29.6% of patients with coronary heart disease and 11% of patients with CVD. The cardiac localization of the including event was independently associated with the control of each of the risk factors studied (hypertension, low-density lipoprotein-cholesterol, smoking) and to the control of all risk factors present and prescription of antiplatelet therapy with an odds ratio (95% confidence interval) of 2.72 (1.97-3.75). CONCLUSION There is a need to improve the control of CV risk factors in secondary prevention patients. This is particularly crucial for patients with CVD.