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 The independent effect of raising HDL-C or lowering TG on the risk of coronary and 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=556) comparing LDL-C reduction with adding ZETIA to a stable dose of atorvastatin 40 mg vs titrating atorvastatin from 40 mg to 80 mg in patients with hypercholesterolemia at high risk for CHD. Mean treated baseline LDL-C for ZETIA added to atorvastatin 40 mg was 89 mg/dL and for atorvastatin 80 mg alone was 90 mg/dL. Patients had a 27% additional mean reduction in LDL-C with adding ZETIA to atorvastatin 40 mg and an 11% additional mean reduction in LDL-C from baseline with titrating atorvastatin 40 mg to 80 mg.
 

Mean treated baseline HDL-C levels were 47 mg/dL for atorvastatin 80 mg alone and 48 mg/dL for ZETIA + atorvastatin 40 mg.

 

Median treated baseline triglyceride (TG) levels were 136 mg/dL for atorvastatin 80 mg alone and 131 mg/dL for ZETIA + atorvastatin 40 mg.
 

Mean treated baseline Apo B levels were 102 mg/dL for atorvastatin 80 mg alone and 101 mg/dL for ZETIA + atorvastatin 40 mg.
 

Reference:
1. Leiter LA, Bays H, Conard S, et al. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008;102:1495–1501.
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21050228(1)-06/10-ZET