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FDA Approves New Label for Ezetimibe/Simvastatin

WHITEHOUSE STATION, N.J. & KENILWORTH, N.J.--(BUSINESS WIRE)--Merck/Schering-Plough Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved the inclusion of new data in the product label that showed Vytorin® (ezetimibe/simvastatin) was more effective than Crestor® (rosuvastatin) at lowering LDL "bad" cholesterol at all doses compared, ranging from the usual recommended starting doses (Vytorin 10/20 mg, Crestor 10 mg) to the maximum approved doses (Vytorin 10/80 mg, Crestor 40 mg).

This study, now included in the label for Vytorin, of 2,959 patients with high cholesterol not at their LDL cholesterol goal showed that Vytorin, along with diet when diet alone is not enough, lowered LDL "bad" cholesterol more than Crestor across all study dose comparisons, 52-61 percent for Vytorin 10/20 mg to 10/80 mg, and 46-57 percent for Crestor 10 mg to 40 mg. In addition, both Vytorin and Crestor raised HDL "good" cholesterol by 8 percent, averaged across all doses studied. The primary endpoint of the study was LDL cholesterol reduction from baseline averaged across all doses. Key secondary endpoints included LDL cholesterol reductions from baseline at each dose comparison. "Vytorin now has been shown in clinical studies to provide greater LDL cholesterol lowering efficacy versus Lipitor® (atorvastatin), Crestor® (rosuvastatin) and Zocor® (simvastatin) at all study dose comparisons," said Deepak Khanna, vice president and general manager of Merck/Schering-Plough Pharmaceuticals. "Vytorin provided the confidence of a 50 percent average LDL cholesterol reduction at the usual recommended starting dose."

Vytorin, which contains ezetimibe and simvastatin, is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food. Vytorin is marketed as INEGY in many countries outside the U.S.

About the study
This randomized, double-blind, six-week, parallel-group study included 2,959 patients with high cholesterol. Patients were randomized equally to one of six treatment groups. Vytorin provided significantly greater LDL cholesterol reduction, compared to Crestor, when averaged across all dose comparisons (56 percent vs. 52 percent; p Both medicines were generally well tolerated in this study.

Important information about Vytorin
Vytorin contains simvastatin and ezetimibe. Vytorin is indicated as adjunctive therapy to diet when diet alone is not enough, for the reduction of elevated total cholesterol, LDL cholesterol, Apo B(1), triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia. No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.

Vytorin is also indicated for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Vytorin is a prescription medicine and should not be taken by people who are hypersensitive to any of its components. Vytorin should not be taken by anyone with active liver disease or unexplained persistent elevations of serum transaminases. Women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant should not take Vytorin.

Selected cautionary information for Vytorin
Muscle pain, tenderness or weakness in people taking Vytorin should be reported to a doctor promptly because these could be signs of a serious side effect. Vytorin should be discontinued if myopathy is diagnosed or suspected. To help avoid serious side effects, patients should talk to their doctor about medicine or food they should avoid while taking Vytorin.

In three placebo-controlled, 12-week trials, the incidence of consecutive elevations (=>3 X ULN) in serum transaminases were 1.7 percent overall for patients treated with Vytorin and 2.6 percent for patients treated with Vytorin 10/80 mg. In controlled long-term (48-week) extensions, which included both newly-treated and previously-treated patients, the incidence of consecutive elevations (=>3 X ULN) in serum transaminases was 1.8 percent overall and 3.6 percent for patients treated with Vytorin 10/80 mg. These elevations in transaminases were generally asymptomatic, not associated with cholestasis and returned to baseline after discontinuation of therapy or with continued treatment. Doctors should perform blood tests before, and periodically during treatment with Vytorin when clinically indicated to check for liver problems. People taking Vytorin 10/80 mg should receive an additional liver function test prior to and three months after titration and periodically during the first year.

Due to the unknown effects of increased exposure to ezetimibe (an ingredient in Vytorin) in patients with moderate or severe hepatic insufficiency, Vytorin is not recommended in these patients. The safety and effectiveness of Vytorin with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Caution should be exercised when initiating Vytorin in patients treated with cyclosporine and in patients with severe renal insufficiency. Vytorin has been evaluated for safety in more than 3,800 patients in clinical trials and was generally well tolerated at all doses (10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg). In clinical trials, the most commonly reported side effects, regardless of cause, included headache (6.8 percent), upper respiratory tract infection (3.9 percent), myalgia (3.5 percent), influenza (2.6 percent) and extremity pain (2.3 percent).

Source: Merck and Schering Plough

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