title: Cardiovascular effects of B-vitamins and/or N-3 fatty acids: the SU.FOL.OM3 trial.
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.
authors.affiliation: Université Paris-Descartes, Faculté de Médecine, AP-HP, Hôtel-Dieu, Centre de Diagnostic et Thérapeutique, Paris, France. jacques.blacher@htd.aphp.fr
authors.forename: Jacques
authors.initials: J
authors.lastname: Blacher
authors.forename: Sébastien
authors.initials: S
authors.lastname: Czernichow
authors.forename: François
authors.initials: F
authors.lastname: Paillard
authors.forename: Pierre
authors.initials: P
authors.lastname: Ducimetiere
authors.forename: Serge
authors.initials: S
authors.lastname: Hercberg
authors.forename: Pilar
authors.initials: P
authors.lastname: Galan
mesh_terms: D000368:Aged; D003327:Coronary Disease / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods; D055502:Secondary Prevention / Q000379:methods*; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D015525:Fatty Acids, Omega-3; D014803:Vitamin B Complex