【medical-news】FDA Approves New Label for Vytorin(R) (Ezet
New Label Includes Data Demonstrating Vytorin Lowered LDL "Bad" Cholesterol more than Crestor at all Doses Compared
WHITEHOUSE STATION, KENILWORTH, NJ -- October 5, 2006 -- 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 low-density lipoprotein (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% for Vytorin 10/20 mg to 10/80 mg, and 46-57% for Crestor 10 mg to 40 mg.
In addition, both Vytorin and Crestor raised HDL "good" cholesterol by 8%, 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% 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% vs. 52%; p<0.001), and at all individual dose comparisons.
The LDL cholesterol reductions for Vytorin compared to Crestor were 52%, Vytorin 10/20 mg vs. 46%, Crestor 10 mg, 55%, Vytorin 10/40 mg vs. 52%, Crestor 20 mg and 61%, Vytorin 10/80 mg vs. 57% for Crestor 40 mg. In addition, Vytorin provided greater reductions compared to Crestor in total cholesterol, apolipoprotein B, and non-HDL cholesterol when averaged across all doses studied and at each dose comparison.
Vytorin also lowered triglycerides by similar levels compared to Crestor when averaged across all doses studied. Effects on HDL cholesterol were similar between Vytorin and Crestor, each raising HDL cholesterol by 8% averaged across the doses studied. The relationship between treatment-induced changes in triglycerides, HDL cholesterol, and apolipoprotein B and risk reduction of cardiovascular morbidity and mortality has not been established. Also, the clinical significance of the above comparisons has not been established.
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 B1, 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.
作者:admin@医学,生命科学 2010-11-18 05:11