In high-risk patients with LDL-C >100 mg/dL and <160 mg/dL1
Patients were taking 1 of 5 existing statin monotherapies for 6 weeks before the switch.
At randomization, statin-treated patients were switched to VYTORIN 10/20 mg or Crestor 10 mg.
Primary end point: Mean percent change in LDL-C from treated baseline.
Secondary end points: (1) Achievement of LDL-C <100 mg/dL and <70 mg/dL; (2) mean percent change in other lipid parameters, including TG, HDL-C, non–HDL-C, and Apo B.
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.
The dosage should be individualized according to the baseline LDL-C level and the patient’s response to treatment.
The clinical impact of comparative differences in lipid changes between products is not known.
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%).
a
Study Design: Data from a multicenter, randomized, double-blind, active-controlled, parallel-group study involving 618 high-risk patients with elevated LDL-C despite prior statin monotherapy. The study was designed to evaluate the efficacy and safety of switching to
VYTORIN 10/20 mg compared with rosuvastatin 10 mg. Following a 6-week, open-label stabilization period with the same statin therapy taken prior to enrollment (atorvastatin 10 or 20 mg, simvastatin 20 or 40 mg, pravastatin 40 mg, fluvastatin 80 mg, or rosuvastatin 5 mg), patients with
LDL-C >100 mg/dL and <160 mg/dL were randomized to receive VYTORIN 10/20 mg (n=314) or rosuvastatin 10 mg (n=304) for 6 weeks. The primary end point was the mean percent change in LDL-C from statin-treated baseline at 6 weeks. Key secondary efficacy variables included the percentage of patients achieving LDL-C <100 mg/dL and <70 mg/dL and the mean percent change in TG, HDL-C, non–HDL-C, and Apo B at study end point.1
VYTORIN 10/20 mg compared with rosuvastatin 10 mg. Following a 6-week, open-label stabilization period with the same statin therapy taken prior to enrollment (atorvastatin 10 or 20 mg, simvastatin 20 or 40 mg, pravastatin 40 mg, fluvastatin 80 mg, or rosuvastatin 5 mg), patients with
LDL-C >100 mg/dL and <160 mg/dL were randomized to receive VYTORIN 10/20 mg (n=314) or rosuvastatin 10 mg (n=304) for 6 weeks. The primary end point was the mean percent change in LDL-C from statin-treated baseline at 6 weeks. Key secondary efficacy variables included the percentage of patients achieving LDL-C <100 mg/dL and <70 mg/dL and the mean percent change in TG, HDL-C, non–HDL-C, and Apo B at study end point.1
Mean treated baseline LDL-C was 124 mg/dL for VYTORIN 10/20 mg and 125 mg/dL for rosuvastatin 10 mg.1
Reference
1.
Farnier M, Averna M, Missault L, et al. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy–the IN-CROSS study. Int J Clin Pract. 2009;63(4):547–559.
