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The clinical impact of comparative differences in lipid changes between products is not known. The dosage should be individualized according to the baseline LDL-C level and the patient’s response to treatment. The independent effect of raising HDL-C on the risk of coronary and cardiovascular morbidity and mortality has not been determined. 
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VYTORIN contains 2 active ingredients: ezetimibe and simvastatin. No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, Apo B, TG, and
non–HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia when diet alone is not enough.
non–HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia when diet alone is not enough.
Contraindications: hypersensitivity to any component of this medication; active liver disease; unexplained persistent elevations in hepatic transaminase levels; and women who are pregnant, nursing, or may become pregnant.
SELECTED DOSAGE AND ADMINISTRATION INFORMATION
VYTORIN is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40, or 80 mg of simvastatin
(VYTORIN 10/10, 10/20, 10/40, or 10/80 mg, respectively).
(VYTORIN 10/10, 10/20, 10/40, or 10/80 mg, respectively).
The recommended usual starting dose is 10/20 mg/day. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. VYTORIN 10/10 mg may be considered for patients requiring less aggressive
LDL-C reduction.
LDL-C reduction.
No dosage adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised when VYTORIN is administered to patients with severe renal insufficiency. VYTORIN should not be initiated in such patients unless the patient has already tolerated treatment with simvastatin.
c
Study Design: A multicenter, double-blind, randomized, active-controlled, 8-arm, parallel-group, 6-week, active-treatment study. Patients with hypercholesterolemia (N=1,902) who had not met their LDL-C goal as defined by NCEP ATP III were randomized to 1 of 8 treatment groups: VYTORIN 10/10, 10/20, 10/40, or 10/80 mg or atorvastatin 10, 20, 40, or 80 mg. The primary end point of the study was mean percent change in LDL-C from untreated baseline averaged across all doses studied. The mean percent reduction in LDL-C across all doses studied was 53% for patients taking VYTORIN vs 45% for patients taking atorvastatin (P<0.001).1
Mean pooled baseline HDL-C levels for both VYTORIN and atorvastatin were 49 mg/dL. Mean baseline HDL-C levels for VYTORIN 10/10 mg, atorvastatin 10 mg, VYTORIN 10/20 mg, atorvastatin 20 mg, VYTORIN 10/40 mg, atorvastatin 40 mg, VYTORIN 10/80 mg, and atorvastatin 80 mg were 49 mg/dL, 48 mg/dL, 49 mg/dL, 49 mg/dL, 49 mg/dL, 50 mg/dL, 49 mg/dL, and 48 mg/dL, respectively.1 VYTORIN 10/10 mg raised HDL-C by 8% from baseline.
Reference
1.
Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. Am Heart J. 2005;149(3):464–473.
