Merck & Co. Inc. announced that the U.S. Food and Drug Administration has approved an updated label for VYTORIN(R) (ezetimibe/simvastatin) that includes results from the Study of Heart and Renal Protection. 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(R) (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. VYTORIN should not be taken with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone); with gemfibrozil, cyclosporine, or danazol; by anyone with active liver disease, unexplained persistent elevations of hepatic transaminase levels, or hypersensitivity to the product; or by women who are pregnant, nursing or may become pregnant. CKD is associated with an increased risk of cardiovascular disease. According to the National Kidney Foundation, patients with CKD should be considered to be at high cardiovascular risk, equivalent to that of patients with coronary heart disease. SHARP is the randomized controlled trial involving LDL cholesterol lowering therapy to demonstrate a reduction in cardiovascular outcomes in patients with CKD SHARP was designed and independently conducted by the Clinical Trial Service Unit of Oxford University (the trial's regulatory sponsor) and CTSU provided the analyses for the FDA. The SHARP trial results were published last June in The Lancet. A total of 9,438 patients with chronic kidney disease were enrolled. Approximately one-third of the patients were undergoing dialysis therapy for end-stage renal disease at the time of entry, and the remaining patients were pre-dialysis patients with advanced CKD with a median estimated glomerular filtration rate (GFR, a measure of kidney function) of 25.6 ml/min/1.73m(2) . Patients with a prior history of myocardial infarction or a coronary (heart) revascularization procedure were excluded from the study. The average baseline LDL cholesterol of all patients enrolled in SHARP was 108 mg/dL. Eligibility did not depend on lipid levels. For the first year of the trial, patients were allocated in a ratio of 4:4:1 to receive VYTORIN 10/20 mg daily, placebo or simvastatin 20 mg alone. After one year, patients initially allocated to simvastatin alone were re-allocated to either VYTORIN 10/20 mg daily or placebo for the remainder of the study period. Patients were followed for a median of 4.9 years.