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VYTORIN 10/80 mg (n=79) was superior to simvastatin 80 mg (n=75) at lowering LDL-C (62% vs 49%, P<0.0001).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. Important Information About VYTORIN in Geriatric Patients Of the 10,189 patients who received VYTORIN in clinical studies, 3,242 (32%) were 65 and older (this included 844 [8%] who were 75 and older). No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Greater sensitivity of some older individuals cannot be ruled out. Since advanced age (>65 years) is a predisposing factor for myopathy, VYTORIN should be prescribed with caution in the elderly. No dosage adjustment is necessary in geriatric 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.
Significance inferred from tests was based on overall treatment effects (where P<0.0001 for VYTORIN vs simvastatin for each dose comparison) because the treatment by age subgroup interaction was not significant.1
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.
Contraindications: hypersensitivity to any component of this medication; active liver disease; unexplained persistent elevations in hepatic transaminase levels; and women who are pregnant, nursing, or may become pregnant.
SELECTED CAUTIONARY INFORMATION
Skeletal Muscle: All patients starting therapy with VYTORIN, or whose dose of VYTORIN is being increased, should be advised of the risk of myopathy and told to promptly report any unexplained muscle pain, tenderness, or weakness. Therapy with VYTORIN should be discontinued immediately if myopathy is diagnosed or suspected.
Myopathy and rhabdomyolysis are known adverse reactions to HMG-CoA reductase inhibitors and other lipid-lowering drugs. VYTORIN contains simvastatin, which occasionally causes myopathy manifested as muscle pain, tenderness, or weakness with CK levels above 10 × ULN. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. Predisposing factors for myopathy include advanced age (>65 years), uncontrolled hypothyroidism, and renal impairment. As with other statins, the risk of myopathy/rhabdomyolysis is dose related. VYTORIN should be discontinued immediately if myopathy is diagnosed or suspected. Please read WARNINGS in the Prescribing Information for additional information.
a
Study Design: Percentage LDL-C reduction by VYTORIN (n=1,226) vs simvastatin (n=1,218) was derived from a post hoc subgroup analysis of pooled data obtained from 3 similarly designed, randomized, multicenter, double-blind, placebo-controlled studies. In each of these studies, the primary end point was percentage change from baseline in LDL-C for VYTORIN vs simvastatin alone. The subgroup analysis included
2 groups: patients aged younger than 65 years and patients aged 65 years or older. Significance inferred from tests was based on overall treatment effects (where P<0.0001 for VYTORIN vs simvastatin for each dose comparison) because the treatment by age subgroup interaction was not significant.1
2 groups: patients aged younger than 65 years and patients aged 65 years or older. Significance inferred from tests was based on overall treatment effects (where P<0.0001 for VYTORIN vs simvastatin for each dose comparison) because the treatment by age subgroup interaction was not significant.1
In the overall population included in the pooled data analysis, the percentage LDL-C reductions for each dose comparison were as follows:
VYTORIN 10/20 mg, 50% vs 35% for simvastatin 20 mg; VYTORIN 10/40 mg, 55% vs 40% for simvastatin 40 mg; and VYTORIN 10/80 mg, 60% vs 47% for simvastatin 80 mg (P<0.0001 for each of these comparisons).1
VYTORIN 10/20 mg, 50% vs 35% for simvastatin 20 mg; VYTORIN 10/40 mg, 55% vs 40% for simvastatin 40 mg; and VYTORIN 10/80 mg, 60% vs 47% for simvastatin 80 mg (P<0.0001 for each of these comparisons).1
Reference
1.
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 20602077(5)-VYT.
