Merck announced today that the U.S. Food and Drug Administration has approved an updated label for Vytorin (ezetimibe/simvastatin) that includes results from the Study of Heart and Renal Protection (SHARP). In SHARP, Vytorin 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease, and major vascular events were reduced in the treatment group compared to placebo. 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.

SHARP is the first 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 (CTSU) 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 of 25.6 ml/min/1.73m.