Merck Drug Vytorin Benefits for Kidney Patients Announced in Study
Findings from Merck's SHARP (Study of Heart and Renal Protection) trial of more than 9000 patients with chronic kidney disease were announced at Renal Week, the American Society of Nephrology's annual meeting today. The drug that is a combination of simvistatin and ezetimide, was shown to lower the chances of first cardiovascular events by 16.1 percent in patients with chronic kidney disease (CKD), compared to placebo.
Merck Plans to Seek Approval for Vytorin in Patients with CKD
The findings have prompted the company to ask for regulatory approval of Vytorin for treatment of patients with CKD who are at high risk for heart attack and stroke.
The drug that lowers LDL, or bad cholesterol levels, prevented major vascular events in patients who primarily had advanced forms of kidney disease. According to Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories, "this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
The study participants were all receiving treatment from nephrologists. One third were pre-dialysis patients, and one third were already on dialysis, with no previous history of heart attack or other vascular event, and a mean LDL level of 108.
In the first part of the trial, patients received Vytorin 10/20 mg, just simvistatin or placebo. After one year, the simvisatin group was switched to either Vytorin or placebo. The subjects were followed for 4.9 years.
When the study compared placebo to Vytorin in the group who received simvistatin for the first year, cardiovascular events were reduced by 15.2 percent. In the first year of the study, placebo lowered LDL level 28 percent and Vytorin 40 percent compared to placebo.
The drug had no impact on the progression of kidney disease, and there were no new safety issues inconsistent with current warnings of liver and muscle pain and weakness associate with cholesterol lowering drugs.
The statin is not yet approved for patients with CKD and prescribing information still stays Vytorin is no more effective than simvistatin taken alone. Results of the SHARP trial could lead to new regulatory approval for use of the combination drug for patients with kidney disease.