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Mean percentage LDL-C reduction from untreated baseline was 55% for VYTORIN 10/40 mg vs 52% for rosuvastatin 20 mg (P<0.05). Mean percentage LDL-C reduction from untreated baseline was 61% for VYTORIN 10/80 mg vs 57% for rosuvastatin 40 mg (P<0.05). The clinical impact of comparative differences in lipid changes between products is not known.  Click to view achievement of LDL-C <100 mg/dL in high-risk patients |
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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.
The dosage should be individualized according to the baseline LDL-C level and the patient’s response to treatment.
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, 6-arm, parallel-group, 6-week, active-treatment study. Patients with hypercholesterolemia (N=2,959) were randomized to 1 of 6 treatment groups: VYTORIN 10/20, 10/40, or 10/80 mg or rosuvastatin 10, 20, or
40 mg. The primary end point of the study was mean percent change in LDL-C from untreated baseline averaged across all doses studied. The percent reduction in LDL-C across all doses studied was 56% for patients taking VYTORIN vs 52% for patients taking rosuvastatin (P<0.001).1
40 mg. The primary end point of the study was mean percent change in LDL-C from untreated baseline averaged across all doses studied. The percent reduction in LDL-C across all doses studied was 56% for patients taking VYTORIN vs 52% for patients taking rosuvastatin (P<0.001).1
Mean pooled baseline LDL-C values for VYTORIN and rosuvastatin were 172 mg/dL and 173 mg/dL, respectively. Mean baseline LDL-C levels for VYTORIN 10/20 mg, rosuvastatin 10 mg, VYTORIN 10/40 mg, rosuvastatin 20 mg, VYTORIN 10/80 mg, and rosuvastatin 40 mg were 172 mg/dL, 172 mg/dL, 173 mg/dL, 173 mg/dL, 172 mg/dL, and 173 mg/dL, respectively.1
Reference
1.
Catapano AL, Davidson MH, Ballantyne CM, et al. Lipid-altering efficacy of the ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Curr Med Res Opin. 2006;22(10):2041–2053.
