Merck and Schering-Plough Pharmaceuticals, announced that the US 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 per cent for Vytorin 10/20 mg to 10/80 mg, and 46-57 per cent 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 and Schering-Plough Pharmaceuticals. "Vytorin provided the confidence of a 50 per cent 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 US.