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 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 or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.
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
Myopathy Caused by Drug Interactions: Use of VYTORIN with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>1 quart daily) should be avoided because of the increased risk of myopathy, particularly at higher doses.
The concomitant use of VYTORIN and fibrates (especially gemfibrozil) should be avoided. Although not recommended, the dose of VYTORIN should not exceed 10/10 mg if used with gemfibrozil.
The benefit of further alterations in lipid levels by the combined use of VYTORIN with niacin (>1 g/day) should be carefully weighed against the potential risks of myopathy. Chinese patients should not receive VYTORIN 10/80 mg daily with niacin (>1 g/day). The dose of VYTORIN should not exceed 10/10 mg daily in patients receiving cyclosporine or danazol, 10/20 mg daily in patients receiving amiodarone or verapamil, and 10/40 mg daily in patients receiving diltiazem, due to the increased risk of myopathy. The combined use of VYTORIN at doses higher than 10/20 mg daily with amiodarone or verapamil or at doses higher than 10/40 mg daily with diltiazem should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy.
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 baseline values for VYTORIN 10/20 mg and rosuvastatin 10 mg, respectively, were as follows: LDL-C, 124 mg/dL and
125 mg/dL; non–HDL-C, 153 mg/dL and 153 mg/dL; Apo B, 120 mg/dL and 118 mg/dL; and HDL-C, 55 mg/dL and 55 mg/dL.
Median baseline TG values were 129 mg/dL for VYTORIN 10/20 mg and 125 mg/dL for rosuvastatin 10 mg.1
The number of patients contributing to the efficacy analyses varied for each of the parameters (VYTORIN 10/20 mg, n=301–305;
rosuvastatin 10 mg, n=292–297).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.
