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FDA rejects new indication for use of combination ezetimibe plus simvastatin in patients with CKD
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Combination ezetimibe plus simvastatin failed to earn FDA approval to prevent major vascular events in patients with chronic kidney disease. However, the agency has approved updated labeling for ezetimibe plus simvastatin that incorporates data from the SHARP trial, according to a press release issued by Merck.
Based on results from the SHARP trial showing that combination ezetimibe/simvastatin (Vytorin, Merck) lowered LDL and decreased major vascular events in patients with CKD compared with placebo, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended approval for the new indication. However, the agency noted that SHARP was designed to study the combination of the two agents as opposed tothe contributions of each individual drug. Therefore, the agency did not approve a new indication for use of the combination medication or ezetimibe alone (Zetia, Merck) in this population. Additionally, the FDA opted not to include information from the SHARP trial in ezetimibe’s labeling.
In SHARP, researchers randomly assigned 9,270 patients with CKD and a known history of MI or coronary revascularization to receive ezetimibe 10 mg plus simvastatin (Zocor, Merck) 20 mg or placebo. According to results, which were published in The Lancet in June 2011, patients in the combined treatment group had an average LDL difference of 0.85 mmol/L during the median follow-up of 4.9 years, which produced a 17% proportional reduction in major atherosclerotic events (11.3%) vs. placebo (13.4%; P=.0021). Fewer patients receiving combined therapy died from CHD (4.6% vs. 5%), and there were also reductions in non-hemorrhagic stroke (2.8% vs. 3.8%) and arterial revascularization procedures (6.1% vs. 7.6%) vs. placebo, but these reductions did not attain statistical significance.
“Merck is committed to supporting clinical research that helps to address important questions in medicine,” Michael Mendelsohn, MD, senior vice president and head of atherosclerosis and CV research at Merck Laboratories said in the release. “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 CV risk in patients with CKD.”
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