WHITEHOUSE STATION, N.J.—The U.S. Food and Drug Administration (FDA) has approved an updated label for Merck's cholesterol drug Vytorin following results from the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease.
"Merck is committed to supporting clinical research that helps to address important questions in medicine," said Michael Mendelsohn, MD, senior vice president & head, atherosclerosis and cardiovascular research, Merck Research Laboratories. "The results of SHARP as described in the new label for Vytorin can help the medical community understand the role of lowering lipids with Vytorin in managing cardiovascular risk in patients with CKD."
In SHARP, Vytorin 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease (CKD), and major vascular events were reduced in the treatment group compared to placebo. The trial therefore demonstrated that treatment with Vytorin 10/20 mg versus placebo reduced the risk for major vascular events in this CKD population.
Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; for this reason, the FDA did not approve a new indication for Vytorin or for Zetia (ezetimibe) and the study's efficacy results have not been incorporated into the label for Zetia.
Vytorin is indicated as adjunctive therapy to diet for the reduction of total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol, and to increase HDL cholesterol in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia when diet alone is not enough. Vytorin contains two active ingredients: ezetimibe and simvastatin. No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
