ZETIA (ezetimibe)

The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.

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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.
bullet gif Contraindications: hypersensitivity to any component of this medication.
bullet gif Statin contraindications apply when used with a statin: active liver disease; unexplained persistent elevations in hepatic transaminase levels. Statins are contraindicated in pregnant and nursing women. Refer to the statin label for details.
SELECTED CAUTIONARY INFORMATION
bullet gif When using ZETIA with a statin, also follow the label recommendations for that specific statin.
bullet gif When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (≥3 × ULN) were slightly higher (1.3%) than those of statins alone (0.4%). Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations. Should an increase in ALT or AST ≥3 × ULN persist, consider withdrawal of ZETIA and/or the statin.
bullet gif Patients should be advised to promptly report muscle pain, tenderness, or weakness. Risk for skeletal muscle toxicity increases with higher statin doses, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Discontinue drug if myopathy is diagnosed or suspected.

Before prescribing ZETIA, please read the Prescribing Information.

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Study Design1: A 6-week, randomized, double-blind study (N=184) comparing LDL-C reduction with adding ZETIA to a stable dose of atorvastatin 20 mg vs titrating atorvastatin from 20 mg to 40 mg in patients with hypercholesterolemia at moderately high risk for CHD. Mean treated baseline LDL-C for ZETIA added to atorvastatin 20 mg was 120 mg/dL and for atorvastatin 40 mg alone was 118 mg/dL. Patients had a 31% additional mean reduction in LDL-C with adding ZETIA to atorvastatin 20 mg and an 11% additional mean reduction in LDL-C from baseline with titrating atorvastatin 20 mg to 40 mg.

 

The projected results shown are based on this study. A 31% additional mean reduction from this hypothetical patient’s treated baseline of 125 mg/dL would result in an LDL-C of 86 mg/dL; an 11% additional mean reduction would result in an LDL-C of 111 mg/dL.
 

Reference:
1. Conard SE, Bays HE, Leiter LA, et al.  Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008;102:1489–1494.
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21050228(1)-06/10-ZET