Washington: High dose B-vitamin therapy leads to a more rapid decline in kidney function and a higher rate of heart attack and stroke in patients with diabetic nephropathy (kidney disease caused by diabetes) than those who received placebo, according to a study.Diabetic nephropathy typically affects the network of tiny blood vessels in the glomerulus, a key structure in the kidney composed of capillary blood vessels, which is necessary for the filtration of the blood."In addition to the personal burden, the societal burden of diabetic nephropathy is enormous, exceeding 10 billion dollars in annual medical expenditures. Despite effective therapies to slow disease progression, approximately 40 percent of the estimated 21 million patients with diabetes in the United States develop overt nephropathy. New treatment approaches to this problem are needed," wrote the authors.
The primary outcome was change in radionuclide glomerular filtration rate (GFR; a measure of kidney function) between baseline and 36 months. Other outcomes included dialysis and a composite of heart attack, stroke, revascularization and all-cause death. Plasma total homocysteine was measured. Participants were followed-up for an average of 31.9 months.The researchers found that participants assigned to the B-vitamin group had a greater decrease in radionuclide GFR (and subsequently poorer kidney function) compared with the placebo group. In addition, participants randomised to receive B vitamins had a significantly greater number of cardiovascular and cerebrovascular events, with the 36-month risk of a composite outcome, including heart attack, stroke, revascularization, and all-cause mortality that was double in the B-vitamin group, compared to the placebo group. There was no difference in requirement of dialysis.Regarding plasma total homocysteine levels, at 36 months, participants in the B-vitamin group had an average decrease while participants in the placebo group had an average increase."Given the recent large-scale clinical trials showing no treatment benefit, and our trial demonstrating harm, it would be prudent to discourage the use of high-dose B vitamins as a homocysteine-lowering strategy outside the framework of properly conducted clinical research," concluded the authors.The study has been published in the latest issue of JAMA. (ANI)
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