 Click to view achievement of LDL-C <100 mg/dL in high-risk patients The dosage should be individualized according to the baseline LDL-C level and the patient’s response to treatment. The clinical impact of comparative differences in lipid changes between products is not known. 
|
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.
a
Study Design: A multicenter, double-blind, placebo-controlled, 12-week study. Patients with primary hypercholesterolemia (N=1,528) 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). The primary end point was the mean percent change in LDL-C from baseline.1
Mean baseline LDL-C was 176 mg/dL for all doses of VYTORIN and 178 mg/dL for all doses of simvastatin. Mean baseline LDL-C for
VYTORIN 10/10 mg, simvastatin 10 mg, VYTORIN 10/20 mg, simvastatin 20 mg, VYTORIN 10/40 mg, simvastatin 40 mg, VYTORIN 10/80 mg, and simvastatin 80 mg were 177 mg/dL, 179 mg/dL, 176 mg/dL, 179 mg/dL, 174 mg/dL, 175 mg/dL, 178 mg/dL, and 179 mg/dL, respectively.2
VYTORIN 10/10 mg, simvastatin 10 mg, VYTORIN 10/20 mg, simvastatin 20 mg, VYTORIN 10/40 mg, simvastatin 40 mg, VYTORIN 10/80 mg, and simvastatin 80 mg were 177 mg/dL, 179 mg/dL, 176 mg/dL, 179 mg/dL, 174 mg/dL, 175 mg/dL, 178 mg/dL, and 179 mg/dL, respectively.2
Patients had a 45% reduction in LDL-C with VYTORIN 10/10 mg vs 33% with simvastatin 10 mg (P<0.0011).
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.
Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 20902252(1)-VYT.
