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Mean percentage LDL-C reduction from baseline in all patients was 51% for VYTORIN 10/20 mg vs 44% for atorvastatin 20 mg (P<0.05) and 36% for atorvastatin 10 mg (P<0.0012). The clinical impact of comparative differences in lipid changes between products is not known. 46% of these patients were at high risk and had an NCEP ATP III LDL-C goal of <100 mg/dL.2  Click to view achievement of LDL-C <70 mg/dL in high-risk patients |
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, 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).2
Mean pooled baseline LDL-C values for VYTORIN and atorvastatin were 178 mg/dL and 179 mg/dL, respectively. Mean baseline LDL-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 177 mg/dL, 175 mg/dL, 179 mg/dL, 178 mg/dL, 178 mg/dL, 180 mg/dL, 178 mg/dL, and 183 mg/dL, respectively.2 70% of patients taking VYTORIN 10/10 mg achieved LDL-C <100 mg/dL vs 39% of patients taking atorvastatin 10 mg (P<0.001).1
References
1.
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 20902475(1)-VYT.
2.
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.
