ZETIA (ezetimibe)

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Important Information About ZETIA
ATORVASTATIN – Stein 2004(2) A Titration Step Delivered LIMITED LDL-C Reduction
Examine Additional Statin Titration Studies
Click here for Study Design
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.

a

Study Design2: A 14-week, double-blind study (N=621) of patients with heterozygous familial hypercholesterolemia, coronary heart disease, or ≥2 cardiovascular risk factors and LDL-C ≥130 mg/dL on atorvastatin 10 mg. This study compared LDL-C efficacy with response-based titration of atorvastatin 10 mg to 80 mg vs adding ZETIA followed by response-based titration of atorvastatin 10 mg to 40 mg. Mean treated baselines were 186 mg/dL (ZETIA + atorvastatin 10 mg) and 187 mg/dL (atorvastatin monotherapy). Percent changes in LDL-C correspond to mean additional LDL-C reductions of 43 mg/dL with ZETIA + atorvastatin 10 mg and 16 mg/dL with atorvastatin titrated from 10 mg to 20 mg.

Evaluating the primary end point over the 14-week study duration, 22% reached protocol-specified LDL-C goal (≤100 mg/dL) with ZETIA + titrated atorvastatin (up to 40 mg) vs 7% with titrated atorvastatin monotherapy (up to 80 mg).

Mean additional LDL-C reductions at Week 9 were 15% in the group receiving atorvastatin monotherapy (27 mg/dL) vs 30% in the group receiving ZETIA + atorvastatin 20 mg (58 mg/dL).6

Mean additional LDL-C reductions at Week 14 were 19% in the group receiving atorvastatin monotherapy (37 mg/dL) vs 32% in the group receiving ZETIA + atorvastatin 40 mg (65 mg/dL).6

References:
2. Stein E, Stender S, Mata P, et al. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatin. Am Heart J. 2004;148:447–455.

6. 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 20705526(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