According to results from the Folic Acid for Vascular Outcome Reduction in Transplantation Trial, treatment with a multivitamin containing high doses of folic acid, B6, and B12 did not improve outcomes in kidney transplant recipients, despite a significant reduction in homocysteine levels.

The authors note that kidney transplant recipients have an increased risk of cardiovascular disease and elevated homocysteine concentrations; the latter has been suggested as a risk factor for cardiovascular disease (CVD).  The purpose of the current study was to determine whether decreasing total homocysteine concentrations in these patients would decrease their CVD risk.

Researchers randomised 4,110 kidney transplant recipients to treatment with a multivitamin containing either a high-dose (n=2,056) or low-dose (n=2,054) of folic acid, vitamin B6, and vitamin B12.  The primary outcome was a composite CVD outcome – after a mean follow-up of four years the use of the high-dose multivitamin did not reduce the rate of this endpoint compared to the low-dose (hazard ratio [HR] 0.99, 95% CI 0.84 to 1.26), despite reducing homocysteine levels.  

The authors comment that their results “add to the growing body of evidence from clinical trials of the failure of homocysteine lowering to reduce CVD, stroke, and all-cause mortality in a wide range of patient populations.”