Reducing homocysteine not beneficial in advanced chronic kidney disease

Clinical Question

Does reducing homocysteine levels with supplemental folic acid and B vitamins reduce mortality or morbidity in patients with chronic kidney disease?

Bottom Line

Supplemental folic acid and B vitamins in patients with chronic kidney disease does not reduce mortality or the incidence of cardiovascular events. (LOE = 1b)

Reference

Jamison RL, Hartigan P, Kaufman JS, et al, for the Veterans Affairs Site Investigators. Effect of homocysteine lowering on mortality and vascular disease in advanced chronic kidney disease and end-stage renal disease. A randomized controlled trial. JAMA 2007;298(10):1163-1170.  [PMID:17848650]

Study Design

Randomized controlled trial (double-blinded)

Funding

Industry + govt

Allocation

Concealed

Setting

Outpatient (any)

Synopsis

Supplemental folic acid and B vitamins is not beneficial in high-risk cardiovascular patients. Whether this is also true for patients with chronic renal disease is unknown. These investigators identified 2056 adults, 21 years or older, with advanced or end-stage chronic kidney disease and elevated homocysteine levels (>= 15 umol/L). Patients randomly received, in double-blind fashion (concealed allocation assignment), a once-daily capsule containing folic acid (40 mg), pyridoxine (100 mg), and cyanocobalamin (2mg), or an identical placebo. Individuals assessing outcomes remained masked to treatment group assignment. Complete follow-up occurred for more than 96% of patients for a median length of 3.2 years. Analyses were by intention to treat. Although plasma homocysteine levels were significantly lower in the intervention group, treatment had no effect on all-cause mortality or the incidence of any secondary outcomes, including myocardial infarction, stroke, or amputation. The study was 80% powered to detect a 17% relative risk reduction in mortality in the intervention group compared with the placebo group.
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