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VYTORIN 10/40 mg provided a 58% mean LDL-C reduction vs 51% for atorvastatin 40 mg (P<0.001).1 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, 5-arm, parallel-group study (6 weeks of active treatment) (N=1,229) that was designed to evaluate the LDL-C efficacy of VYTORIN vs atorvastatin at the recommended usual starting doses (10/20 mg vs 10 mg and 20 mg, respectively) and at the next higher doses (10/40 mg vs 40 mg) in patients with type 2 diabetes mellitus and hypercholesterolemia who had not met an LDL-C goal of <100 mg/dL as recommended by NCEP ATP III. The primary end point was the percent reduction from baseline in LDL-C level.1
Mean pooled baseline LDL-C values for VYTORIN and atorvastatin were 145 mg/dL and 146 mg/dL, respectively. Mean baseline LDL-C values for VYTORIN 10/20 mg, atorvastatin 10 mg, atorvastatin 20 mg, VYTORIN 10/40 mg, and atorvastatin 40 mg were 145 mg/dL, 145 mg/dL, 147 mg/dL, 144 mg/dL, and 146 mg/dL, respectively.1
Reference
1.
Goldberg RB, Guyton JR, Mazzone T, et al. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006;81(12):1579–1588.
