FDA Backs Merck's Vytorin in Kidney Disease Patients

The Food and Drug Administration (FDA) has stated that Merck's cholesterol drug Vytorin helps reduce heart attack, stroke and related problems in patients with chronic kidney disease (CKD). Vytorin is a combination of ezetimibe and simvastatin. Vytorin which had come under scrutiny in 2008 for potential cancer risks has no new safety concerns. Vytorin lowered heart related problems in kidney patients upto 16% as compared to placebo. These results were variable on whether the patients were on dialysis. Patients who received dialysis showed 6% reduction in heart problems as compared to 22% reduction for patients not on dialysis.

The FDA will ask members of the Endocrinologic and Metabolic Drugs Advisory Committee to comment on the disparity and to vote on the overall safety and efficacy of Vytorin for kidney disease patients on Wednesday.

Source-Medindia