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Mean percentage LDL-C reduction from untreated baseline was 52% for VYTORIN 10/20 mg vs 46% for rosuvastatin 10 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 <70 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.
SELECTED CAUTIONARY INFORMATION
Liver: Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate or severe hepatic impairment, VYTORIN is not recommended in these patients.
The incidence of consecutive elevations (>3 × ULN) in serum transaminases was 1.7% overall and appeared to be dose related, with an incidence of 2.6% for 10/80 mg. In long-term (48-week) extensions, which included both newly treated and previously treated patients, the incidence was 1.8% overall and 3.6% for 10/80 mg. These elevations were generally asymptomatic, not associated with cholestasis, and reversible whether treatment was maintained or discontinued.
Liver function tests should be performed at treatment initiation and thereafter when clinically indicated. Patients titrated to 10/80 mg should receive an additional test prior to titration, 3 months after titration, and periodically thereafter (eg, semiannually) during the first year. If an increase in AST or ALT of >3 × ULN persists, discontinue the drug.
In clinical trials, the most commonly reported side effects, regardless of cause, included headache (5.8%), increased ALT (3.7%), myalgia (3.6%), upper respiratory tract infection (3.6%), and diarrhea (2.8%).
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
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.
