 Click to view achievement of LDL-C <100 mg/dL in high-risk patients 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. 
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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.
SELECTED CAUTIONARY INFORMATION
Myopathy Caused by Drug Interactions: Use of VYTORIN with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided because of the increased risk of myopathy, particularly at higher doses.
The concomitant use of VYTORIN and fibrates (especially gemfibrozil) should be avoided. Although not recommended, the dose of VYTORIN should not exceed 10/10 mg if used with gemfibrozil.
The benefit of further alterations in lipid levels by the combined use of VYTORIN with niacin (>1 g/day) should be carefully weighed against the potential risks of myopathy. Chinese patients should not receive VYTORIN 10/80 mg daily with niacin (>1 g/day). The dose of VYTORIN should not exceed 10/10 mg daily in patients receiving cyclosporine or danazol, 10/20 mg daily in patients receiving amiodarone or verapamil, and 10/40 mg daily in patients receiving diltiazem, due to the increased risk of myopathy. The combined use of VYTORIN at doses higher than 10/20 mg daily with amiodarone or verapamil or at doses higher than 10/40 mg daily with diltiazem should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy.
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.
