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Important Information About ZETIA
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bullet gif The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
bullet gif ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, and Apo B in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia when diet alone is not enough.
SELECTED CAUTIONARY INFORMATION
bullet gif ZETIA is not recommended in patients with moderate to severe hepatic impairment.
bullet gif The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
bullet gif Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
bullet gif ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
bullet gif In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin vs statin alone included nasopharyngitis (3.7% vs 3.3%), myalgia (3.2% vs 2.7%), upper respiratory tract infection (2.9% vs 2.8%), arthralgia (2.6% vs 2.4%), and diarrhea (2.5% vs 2.2%); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3% vs 2.5%), diarrhea (4.1% vs 3.7%), arthralgia (3.0% vs 2.2%), sinusitis (2.8% vs 2.2%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%).

Before prescribing ZETIA, please read the Prescribing Information.

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Study Design1: Four multicenter, randomized, double-blind, placebo-controlled, balanced, parallel-group trials were pooled for analysis to compare the efficacy and safety of statin monotherapy vs ZETIA + statin in older and younger adults (N=1,861) with primary hypercholesterolemia. In each of the 4 primary studies, patients were randomized to receive placebo, statin monotherapy, or ZETIA + statin for 12 weeks. The primary end point was the percent reduction in LDL-C from baseline; mean baseline for all age groups was 178 mg/dL. An age subset analysis was carried out to determine whether the incremental reduction in LDL-C with coadministration of ZETIA + statin vs statin monotherapy was similar across age groups.
 

Mean reduction in LDL-C from baseline for patients aged <65 years was –32% and –45% for pooled statin monotherapy and ZETIA + pooled statin, respectively.2

 

Mean reduction in LDL-C from baseline for patients aged ≥65 years was –35% and –50% for pooled statin monotherapy and ZETIA + pooled statin, respectively.2
 

References:
1. Lipka L, Sager P, Strony J, et al. Efficacy and safety of coadministration of ezetimibe and statins in elderly patients with primary hypercholesterolemia. Drugs Aging. 2004;21:1025–1032.
 

2. 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 20603078(2)-ZET.

 

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ZETIA and VYTORIN are registered trademarks of MSP Singapore Company, LLC.

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21050228(1)-06/10-ZET