Western Norway B-vitamin Intervention Trial.pptVIP

Western Norway B-vitamin Intervention Trial WENBIT Trial: Background and Objectives Background Homocysteine-hypothesis of vascular disease Vitamin B6 status cardiovascular risk modifier Objectives To study the effect of homocysteine-lowering therapy with folic acid + vitamin B12, and the separate effect of vitamin B6 therapy, on mortality and cardiovascular events in patients undergoing coronary angiography. Study Population 3090 patients with stable angina (84%), ACS (15%), or aortic valve stenosis (1%), undergoing coronary angiography at Bergen or Stavanger University Hospitals, 1999-2004 Sample Size Calculation Sample size N = 3088 to give 80% power to detect 20% difference if: Follow-up 4 years 4-year total event rate 22% Drop-outs ≤ 20% At a 5% significance level Intervention Groups Primary End Point A composite of: Death (all cause) Non-fatal acute myocardial infarction Acute hospitalization for unstable angina With ECG signs of acute ischemia and/or With angiographically verified progression Non-fatal thromboembolic stroke WENBIT Trial: Baseline Characteristics 1 WENBIT Trial: Baseline Characteristics 2 WENBIT Trial: Baseline Characteristics 3 Baseline Vitamin Status No mandatory folic acid fortification of foods in Norway 19% used B-vitamin supplements containing small doses of folic acid Supplement users had somewhat lower total homocysteine levels (10.6 μmol/L) than non-users (10.8 μmol/L), p= 0.02 Follow Up Study visits at 1 month, 12 months, and final after median follow-up time 38 months 18% drop-outs, no significant differences in drop-out rates Intervention terminated ahead of schedule for 22% of participants October 2005 422 participants (13.7%) with events classified as the primary end point (intention to treat). Folate Levels Homocysteine-Lowering Events in Primary End Point* Primary End Point – 422 Events Norwegian Secondary Prevention Trials with Identical B-vitamin Intervention WENBIT Large B-vitamin intervention trial in population with m