CardioExchange Archive

Vitamin B May Be Harmful in Diabetic Nephropathy: Once again the early hopes for vitamin B have been dashed against the rocks of a clinical trial. In a paper in the Journal of the American Medical Association, Andrew House and colleagues report the results of DIVINe (Diabetic Intervention with Vitamins to Improve Nephropathy), a multicenter, double-blind trial in which 238 patients with diabetic nephropathy were randomized to either B vitamins or placebo. After three years, GFR declined more in the group taking B vitamins than in the group taking placebo. Even more troubling, the composite outcome of MI, stroke, revascularization, and all-cause mortality occurred twice as often in the B vitamin group than in the placebo group (24% vs. 14%, HR=2.0, CI=1.0-4.0, p=0.04). The authors concluded: “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.”

Judge Rejects Guidant Plea Agreement:
A U.S. federal judge has turned down a proposed plea agreement that would have allowed Boston Scientific to settle a case against it for $296 million. The investigation began in 2005 when cardiologists Barry Maron and Robert Hauser accused Guidant (now owned by Boston Scientific) of concealing flaws in the company’s ICDs. Last week the two cardiologists asked the judge to reject the agreement, saying a fine “does not hold the guilty parties fully accountable and inevitably undermines patient safety,” according to a news report in the Minneapolis Star Tribune.