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 <70 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.

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.

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.

Before prescribing VYTORIN, please read the Prescribing Information.

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

Patients had a 45% reduction in LDL-C with VYTORIN 10/10 mg vs 33% with simvastatin 10 mg (P<0.001¹).

References

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.

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.