Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients

Author:

Bostom Andrew G.1,Carpenter Myra A.1,Kusek John W.1,Levey Andrew S.1,Hunsicker Lawrence1,Pfeffer Marc A.1,Selhub Jacob1,Jacques Paul F.1,Cole Edward1,Gravens-Mueller Lisa1,House Andrew A.1,Kew Clifton1,McKenney Joyce L.1,Pacheco-Silva Alvaro1,Pesavento Todd1,Pirsch John1,Smith Stephen1,Solomon Scott1,Weir Matthew1

Affiliation:

1. From the Rhode Island Hospital, Providence (A.G.B., J.L.M.); Department of Biostatistics, the University of North Carolina, Chapel Hill (M.A.C., L.G.-M.); National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (J.W.K.); Tufts Medical Center, Boston, MA (A.S.L.); University of Iowa, Iowa City (L.H.); Brigham and Women's Hospital, Boston, MA (M.A.P., S. Solomon); US Department of Agriculture, Jean Mayer Human Nutrition Research Center on Aging, Boston, MA (J.S., P.F.J.);...

Abstract

Background— Kidney transplant recipients, like other patients with chronic kidney disease, experience excess risk of cardiovascular disease and elevated total homocysteine concentrations. Observational studies of patients with chronic kidney disease suggest increased homocysteine is a risk factor for cardiovascular disease. The impact of lowering total homocysteine levels in kidney transplant recipients is unknown. Methods and Results— In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing total homocysteine concentrations reduced the rate of the primary composite arteriosclerotic cardiovascular disease outcome (myocardial infarction, stroke, cardiovascular disease death, resuscitated sudden death, coronary artery or renal artery revascularization, lower-extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high-dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n=547 total events; hazards ratio [95 confidence interval]=0.99 [0.84 to 1.17]), secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86 to 1.26]), or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93 to 1.43]) compared to the low-dose multivitamin. Conclusions— Treatment with a high-dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00064753.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference42 articles.

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2. The natural history of homocystinuria due to cystathionine beta-synthase deficiency;Mudd SH;Am J Hum Genet,1985

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