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Incremental change from hypothetical patient treated baseline.
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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.
The hypothetical patient response was based on the following study:
Study Design: A 12-week, multicenter, randomized, double-blind, placebo-controlled, factorial design study in patients with primary hypercholesterolemia (N=1,528). Patients were randomized to receive 1 of 10 treatments: placebo, ezetimibe (10 mg), simvastatin (10, 20, 40, or 80 mg), or VYTORIN (10/10, 10/20, 10/40, or 10/80 mg).1
Study Design: A 12-week, multicenter, randomized, double-blind, placebo-controlled, factorial design study in patients with primary hypercholesterolemia (N=1,528). Patients were randomized to receive 1 of 10 treatments: placebo, ezetimibe (10 mg), simvastatin (10, 20, 40, or 80 mg), or VYTORIN (10/10, 10/20, 10/40, or 10/80 mg).1
Mean baseline LDL-C was 176 mg/dL for all doses of VYTORIN and 178 mg/dL for all doses of simvastatin. Patients had a 34.2% reduction from untreated baseline with simvastatin 20 mg; a 40.6% reduction with simvastatin 40 mg; a 48.5% reduction with simvastatin 80 mg; and a 55.2% reduction with VYTORIN 10/40 mg.1
The projected results shown are based on this study. A 40.6% reduction from this hypothetical patient’s untreated baseline of 155 mg/dL resulted in an LDL-C of 92 mg/dL with simvastatin 40 mg; a 48.5% reduction resulted in an LDL-C of 80 mg/dL with simvastatin 80 mg; and a 55.2% reduction resulted in an LDL-C of 69 mg/dL with VYTORIN 10/40 mg.
References
1.
Bays HE, Ose L, Fraser N, et al; for Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004;26(11):1758–1773.
2.
Grundy SM, Cleeman JI, Merz CNB, et al; for Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110(2):227–239.
