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VYTORIN 10/40 mg lowered TG by 30% compared with 28% for atorvastatin 40 mg (P=NS).1 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 lowering TG 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.
a
Study Design: A multicenter, double-blind, randomized, active-controlled, 5-arm, parallel-group study (6 weeks of active treatment) (N=1,229) that was designed to evaluate the LDL-C efficacy of VYTORIN vs atorvastatin at the recommended usual starting doses (10/20 mg vs 10 mg and 20 mg, respectively) and at the next higher doses (10/40 mg vs 40 mg) in patients with type 2 diabetes mellitus and hypercholesterolemia who had not met an LDL-C goal of <100 mg/dL as recommended by NCEP ATP III. The primary end point was the percent reduction from baseline in LDL-C level.1
Median baseline TG levels for VYTORIN 10/20 mg, atorvastatin 10 mg, atorvastatin 20 mg, VYTORIN 10/40 mg, and atorvastatin 40 mg were
173 mg/dL, 191 mg/dL, 175 mg/dL, 175 mg/dL, and 176 mg/dL, respectively.1
173 mg/dL, 191 mg/dL, 175 mg/dL, 175 mg/dL, and 176 mg/dL, respectively.1
Reference
1.
Goldberg RB, Guyton JR, Mazzone T, et al. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006;81(12):1579–1588.
