Reducing LDL Cholesterol: Dual inhibition information at zetia.com Cholesterol Absorption

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 Design: Four 12-week, double-blind studies evaluating ZETIA coadministered with atorvastatin (N=628, 10–80 mg) compared with atorvastatin alone in patients with hypercholesterolemia. Results were pooled across each statin dose range; results shown are for all atorvastatin doses alone (n=248) vs ZETIA + atorvastatin (n=255).

 

Mean baseline LDL-C for atorvastatin alone was 180 mg/dL and for ZETIA + atorvastatin was 180 mg/dL.

 

Mean baseline HDL-C for atorvastatin alone was 54 mg/dL and for ZETIA + atorvastatin was 51 mg/dL.

 

Median baseline TG for atorvastatin alone was 155 mg/dL and for ZETIA + atorvastatin was 165 mg/dL.

 

Mean baseline Apo B for atorvastatin alone was 168 mg/dL and for ZETIA + atorvastatin was 170 mg/dL.

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21050228(1)-06/10-ZET