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VYTORIN 10/40 mg raised HDL-C by 6% compared with 2% 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. 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.
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%).
c
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 HDL-C values for both VYTORIN and atorvastatin were 46 mg/dL. Mean baseline HDL-C values for VYTORIN 10/20 mg, atorvastatin 10 mg, atorvastatin 20 mg, VYTORIN 10/40 mg, and atorvastatin 40 mg were 45 mg/dL, 45 mg/dL, 47 mg/dL, 47 mg/dL,
and 46 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.
