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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 raising HDL-C 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 CAUTIONARY INFORMATION
Skeletal Muscle: All patients starting therapy with VYTORIN, or whose dose of VYTORIN is being increased, should be advised of the risk of myopathy and told to promptly report any unexplained muscle pain, tenderness, or weakness. Therapy with VYTORIN should be discontinued immediately if myopathy is diagnosed or suspected.
Myopathy and rhabdomyolysis are known adverse reactions to HMG-CoA reductase inhibitors and other lipid-lowering drugs. VYTORIN contains simvastatin, which occasionally causes myopathy manifested as muscle pain, tenderness, or weakness with CK levels above 10 × ULN. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. Predisposing factors for myopathy include advanced age (>65 years), uncontrolled hypothyroidism, and renal impairment. As with other statins, the risk of myopathy/rhabdomyolysis is dose related. VYTORIN should be discontinued immediately if myopathy is diagnosed or suspected. Please read WARNINGS in the Prescribing Information for additional information.
a
Study Design: A multicenter, randomized, double-blind, 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
Mean pooled baseline HDL-C levels for both VYTORIN and rosuvastatin were 50 mg/dL. Mean baseline HDL-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 51 mg/dL, 51 mg/dL, 50 mg/dL,
50 mg/dL, 50 mg/dL, and 50 mg/dL, respectively.1
50 mg/dL, 50 mg/dL, and 50 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.
