Merck & Co. has expressed its confidence in the safety and efficacy profiles of Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin). The results of ARBITER 6 were widely predicted because the study design favored niacin as the patient population selected had well-controlled LDL cholesterol and relatively low HDL cholesterol.
Merck has reviewed the data from 43 completed shorter-term clinical trials involving approximately 2,400 patients who received Ezetimibe alone and 13,600 patients who received Ezetimibe with Statins. The two longer-term studies make confident that the data support the safety profiles of Zetia and Vytorin as described in their labels.
In clinical studies, Vytorin was shown to be more effective than simvastatin, Lipitor, or Crestor at lowering LDL cholesterol at the doses compared like Vytorin provided >50 %mean LDL cholesterol reduction. In addition, in these separate studies, Vytorin helped more patients achieve a goal of <70mg/dL than did simvastatin, Lipitor, or Crestor.
The clinical impact of comparative differences in lipid changes between products is not known. It has not been shown to reduce heart attacks and strokes more than simvastatin alone.
Vytorin contains Simvastatin and Ezetimibe. Vytorin is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B2 , triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia.
Zetia, along with diet, is indicated for use either by itself or together with statins or fenofibrate in patients with high cholesterol to reduce LDL cholesterol and total cholesterol when the response to diet and exercise has been inadequate.
Vytorin has been evaluated for safety in more than 10,100 patients in clinical trials and was generally well tolerated at all doses (10/10mg, 10/20mg, 10/40mg, 10/80mg).