Open AccessB Vitamins and the Risk of Total Mortality and Cardiovascular Disease in End-Stage Renal Disease
Author(s) -
Judith Heinz,
Siegfried Kropf,
Ute Domröse,
Sabine Westphal,
Katrin Borucki,
Claus Luley,
Klaus Neumann,
Jutta Dierkes
Publication year - 2010
Publication title -
circulation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 7.795
H-Index - 607
eISSN - 1524-4539
pISSN - 0009-7322
DOI - 10.1161/circulationaha.109.904672
Subject(s) - medicine , hazard ratio , hyperhomocysteinemia , placebo , homocysteine , gastroenterology , end stage renal disease , vitamin , dialysis , hemodialysis , risk factor , confidence interval , kidney disease , surgery , pathology , alternative medicine
Background— In observational studies, hyperhomocysteinemia has been found to be a risk factor for total mortality and cardiovascular events in patients with end-stage renal disease. These patients have grossly elevated homocysteine levels that can be lowered by supplementation with folic acid and vitamin B12 . We conducted a randomized clinical trial with B vitamins to reduce homocysteine levels and therefore cardiovascular events and total mortality.Methods and Results— This randomized, double-blind multicenter study was conducted in 33 dialysis centers in north and east Germany between July 2002 and July 2008. We randomly assigned 650 patients with end-stage renal disease who were undergoing hemodialysis to 2 postdialysis treatments: 5 mg folic acid, 50 μg vitamin B12 , and 20 mg vitamin B6 (active treatment) or 0.2 mg folic acid, 4 μg vitamin B12 , and 1.0 mg vitamin B6 (placebo) given 3 times per week for an average of 2 years. The primary outcome was total mortality; the secondary outcome was fatal and nonfatal cardiovascular events. The primary outcome occurred in 102 patients (31%) receiving the active treatment and in 92 (28%) receiving placebo (hazard ratio, 1.13; 95% confidence interval, 0.85 to 1.50;P =0.51). The secondary outcome occurred in 83 patients (25%) receiving the active treatment and in 98 (30%) receiving placebo (hazard ratio, 0.80; 95% confidence interval, 0.60 to 1.07;P =0.13).Conclusions— Increased intake of folic acid, vitamin B12 , and vitamin B6 did not reduce total mortality and had no significant effect on the risk of cardiovascular events in patients with end-stage renal disease.Clinical Trial Registration— URL: www.anzctr.org.au. Unique identifier: ACTRN12609000911291. URL: www.cochrane-renal.org. Unique identifier: CRG010600027.