 |
a
Hypothetical patient response was based on the results of the VYVA study, Ballantyne CM et al.
b
BP: 136/85 mmHg.
|
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.
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.
The hypothetical patient response was based on the following study:
Study Design: A multicenter, double-blind, randomized, active-controlled, 8-arm, parallel-group, 6-week, active-treatment study. Patients with hypercholesterolemia (N=1,902) who had not met their LDL-C goal as defined by NCEP ATP III were randomized to 1 of 8 treatment groups: VYTORIN 10/10, 10/20, 10/40, or 10/80 mg or atorvastatin 10, 20, 40, or 80 mg. The primary end point of the study was mean percent change in LDL-C from untreated baseline averaged across all doses studied. The mean percent reduction in LDL-C across all doses studied was 53% for patients taking VYTORIN vs 45% for patients taking atorvastatin (P<0.001).1
Study Design: A multicenter, double-blind, randomized, active-controlled, 8-arm, parallel-group, 6-week, active-treatment study. Patients with hypercholesterolemia (N=1,902) who had not met their LDL-C goal as defined by NCEP ATP III were randomized to 1 of 8 treatment groups: VYTORIN 10/10, 10/20, 10/40, or 10/80 mg or atorvastatin 10, 20, 40, or 80 mg. The primary end point of the study was mean percent change in LDL-C from untreated baseline averaged across all doses studied. The mean percent reduction in LDL-C across all doses studied was 53% for patients taking VYTORIN vs 45% for patients taking atorvastatin (P<0.001).1
Mean pooled baseline LDL-C values for VYTORIN and atorvastatin were 178 mg/dL and 179 mg/dL, respectively. Mean baseline LDL-C levels for VYTORIN 10/10 mg, atorvastatin 10 mg, VYTORIN 10/20 mg, atorvastatin 20 mg, VYTORIN 10/40 mg, atorvastatin 40 mg, VYTORIN 10/80 mg, and atorvastatin 80 mg were 177 mg/dL, 175 mg/dL, 179 mg/dL, 178 mg/dL, 178 mg/dL, 180 mg/dL, 178 mg/dL, and 183 mg/dL, respectively.1
References
1.
Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. Am Heart J. 2005;149(3):464–473.
2.
Grundy SM, Cleeman JI, Merz CNB, et al; for Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110(2):227–239.
