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
ATORVASTATIN – Illingworth 2001(4) 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.
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 Design4: A 36-week, randomized, double-blind, parallel-group, dose-titration study in patients (N=826) with hypercholesterolemia with LDL-C >160 mg/dL and triglycerides <350 mg/dL randomized to receive either simvastatin 40 mg titrated to 80 mg at 6 weeks or atorvastatin 20 mg titrated every 6 weeks up to 80 mg. The primary end point was change from baseline in HDL-C averaged across the 2 dose comparisons in the initial 12 weeks. Mean baseline HDL-C and LDL-C levels were 50 mg/dL and 209 mg/dL for the simvastatin group and 51 mg/dL and 206 mg/dL for the atorvastatin group, respectively. Across Weeks 6 and 12, mean change from baseline in HDL-C was 9% with simvastatin vs 7% with atorvastatin (P<0.001).

After 6 weeks, mean LDL-C reduction from baseline was 46% with atorvastatin 20 mg vs 42% with simvastatin 40 mg (P≤0.001). After 12 weeks, mean LDL-C reduction from baseline was 51% with atorvastatin 40 mg vs 49% with simvastatin 80 mg (P≤0.001). After Weeks 18 to 36, mean LDL-C reduction from baseline was 54% with atorvastatin 80 mg vs 48% with simvastatin 80 mg (P≤0.001).

Additional LDL-C reduction provided by titration of atorvastatin 20 mg to 40 mg was 5% and from atorvastatin 40 mg to 80 mg was 3%. Additional LDL-C reduction provided by titration of simvastatin 40 mg to 80 mg was 6%.

The additional percent reductions in LDL-C with successive doses were obtained by subtraction from data presented.

Reference:
4. Illingworth DR, Crouse JR III, Hunninghake DB, et al. A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial. Curr Med Res Opin. 2001;17:43–50.

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

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21050228(1)-06/10-ZET