Source: DGNews  |  Posted 2 years ago

By Kristina Rebelo

SAN DIEGO -- November 13, 2009 -- Results of a clinical trial suggest that relative to high-dose multivitamins, low-dose multivitamins in stable renal transplant recipients (RTRs) lowers the plasma total homocysteine (tHcy).

This tHcy reduction reduces the risk of cardiovascular (CV) outcomes including CV death, myocardial infarction, resuscitated sudden death, stroke, or specific invasive procedures for CV disease (CVD), peripheral vascular disease (PVD), and renovascular disease, according to a late-breaking presentation October 29 at the American Society of Nephrology (ASN) Renal Week 2009.

A randomised, double-blind, controlled trial was conducted at 30 clinical sites in North America and Brazil with a study population consisting of 4,110 patients (63% male), known as the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial.

Patients were randomised in equal numbers to high-dose (HD) folic acid 5.0 mg, pyridoxine 50 mg, and cyanocobalamin 1.0 mg or a low-dose (LD) multivitamin devoid of folic acid.

There were semi-annual follow-up contacts alternating between in-person clinic and telephone contact made to access CVD outcomes. The overall follow-up rate with this large population of study participants was 93% across all visits.

“The transplantation population is highly motivated, which makes it easier to recruit them into trials,” said Andrew G. Bostom, MD, Division of Renal Diseases, Memorial Hospital of Rhode Island, Providence, Rhode Island.

There was a median follow-up period of 3.5 years reached prior to the early closing of the trial for futility on June 24, 2009. Based on preliminary data, researchers reported that 354 (9%) participants had withdrawn consent and 454 (11%) participants had died.

Mean change (95% confidence interval) in tHcy from baseline to 4 years in a sample (n = 143) was -4.6 (-5.7, -3.6) in the HD group and -0.2 (-1.4, 1.0) mcmol/L in the LD group (baseline values of 16.4 and 16.1 mcmol/L, respectively).

Preliminary results for primary and secondary endpoints include 236 HD and 252 LD pooled primary CVD endpoints (P = .70); 202 HD and 195 LD all-cause deaths (P = .50); and 149 HD and 139 LD patients that developed dialysis-dependent ESRD (P = .35).

Dr. Bostom said that his research group would continue mining this large population of patients for further studies.

“There is already another large study underway where we supplied a number of patients with heart failure,” he said, “Even though in our study, the patients were very early in their cardiovascular history.”

Funding for this study was provided by the Office of Dietary Supplements and the National Institute of Diabetes and Digestive and Kidney Diseases.

[Presentation title: Homocysteine-Lowering in Chronic Stable Renal Transplant Recipients: The FAVORIT Trial. Abstract LB-001]