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Mean percentage LDL-C reduction from a pooled analysis of all doses in all patients was 53% for VYTORIN vs 39% for simvastatin (P<0.001).1 The clinical impact of comparative differences in lipid changes between products is not known. 23% 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 <100 mg/dL in high-risk patients 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, placebo-controlled, 12-week study. Patients with primary hypercholesterolemia (N=1,528) were randomized to receive 1 of 10 treatments: placebo, ezetimibe (10 mg), simvastatin (10, 20, 40, or 80 mg), or VYTORIN (10/10, 10/20, 10/40, or 10/80 mg). The primary end point was the mean percent change in LDL-C from baseline.1
Mean baseline LDL-C was 176 mg/dL for all doses of VYTORIN and 178 mg/dL for all doses of simvastatin. Mean baseline LDL-C for
VYTORIN 10/10 mg, simvastatin 10 mg, VYTORIN 10/20 mg, simvastatin 20 mg, VYTORIN 10/40 mg, simvastatin 40 mg, VYTORIN 10/80 mg,
and simvastatin 80 mg were 177 mg/dL, 179 mg/dL, 176 mg/dL, 179 mg/dL, 174 mg/dL, 175 mg/dL, 178 mg/dL, and 179 mg/dL, respectively.2
VYTORIN 10/10 mg, simvastatin 10 mg, VYTORIN 10/20 mg, simvastatin 20 mg, VYTORIN 10/40 mg, simvastatin 40 mg, VYTORIN 10/80 mg,
and simvastatin 80 mg were 177 mg/dL, 179 mg/dL, 176 mg/dL, 179 mg/dL, 174 mg/dL, 175 mg/dL, 178 mg/dL, and 179 mg/dL, respectively.2
Patients had a 45% reduction in LDL-C with VYTORIN 10/10 mg vs 33% with simvastatin 10 mg (P<0.0011).
References
1.
Bays HE, Ose L, Fraser N, et al; for Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004;26(11):1758–1773.
2.
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 20902252(1)-VYT.
