ZETIA (ezetimibe)

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

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Important Information About ZETIA

Learn About ZETIA

Mechanism of Action
An overview of how ZETIA + a statin dramatically reduce LDL-C through dual inhibition, targeting both cholesterol absorption and production.
LDL-C Efficacy: Coadministration With Simvastatin
See data showing that administration of ZETIA + simvastatin provided dramatically more LDL-C reduction than the corresponding doses of simvastatin monotherapy.
Hypothetical Patient Case
Decide whether you would add ZETIA for a statin-treated patient who is further from LDL-C goal on atorvastatin 10 mg.
TG Efficacy
Review the effects on TG levels with administration of ZETIA + atorvastatin vs atorvastatin monotherapy.
Coadministration With Fenofibrate
Review effects on LDL-C levels with administration of ZETIA + fenofibrate compared with fenofibrate monotherapy.
Head-to-Head Comparison of Treatment Strategies
Learn more about a head-to-head study that compared adding ZETIA to atorvastatin 10 mg vs titrating atorvastatin 10 mg to 20 mg.
LDL-C Efficacy: Coadministration With Atorvastatin
See data showing that administration of ZETIA + atorvastatin provided dramatically more LDL-C reduction than the corresponding doses of atorvastatin monotherapy.
LDL-C Efficacy of Monotherapy
Learn more about the significant LDL-C reduction provided by ZETIA.
HDL-C Efficacy
See the effects on HDL-C when ZETIA was added to atorvastatin vs atorvastatin monotherapy.
LDL-C Efficacy: Patients Aged <65 and ≥65 Years
Learn more about the LDL-C efficacy of adding ZETIA to statins in patients aged <65 and ≥65 years.
 

Important Information About ZETIA

The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.

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.

Contraindications: hypersensitivity to any component of this medication.
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.

When using ZETIA with a statin, also follow the label recommendations for that specific statin.

Selected Cautionary Information: When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (>3 x 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 x ULN persist, consider withdrawal of ZETIA and/or the statin.

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.

ZETIA is not recommended in patients with moderate to severe hepatic impairment.

The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.

Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.

ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.

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%), and pain in extremity (2.7% vs 2.5%).

Before prescribing ZETIA, please read the Prescribing Information.

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For non-US health care professionals, click here.

ZETIA and VYTORIN are registered trademarks of MSP Singapore Company, LLC.
20951486(2)-08/09-ZET