Reducing LDL Cholesterol

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Important Information About ZETIA

For this hypothetical patient further from LDL-C goal Adding ZETIA Gives Him the DRAMATIC Additional LDL-C Reduction He Needs

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Study Design: Projected results based on a 12-week, double-blind study (N=628) comparing ZETIA initiated concurrently with atorvastatin vs atorvastatin alone in patients with primary hypercholesterolemia. Mean baseline LDL-C for ZETIA + atorvastatin was 182 mg/dL and for atorvastatin alone was 181 mg/dL.1 Patients had a 37% reduction in LDL-C from untreated baseline with atorvastatin 10 mg; a 42% reduction in LDL-C with atorvastatin 20 mg; a 45% reduction with atorvastatin 40 mg; and a 53% reduction with ZETIA + atorvastatin 10 mg. A 37% reduction from this hypothetical patient's baseline of 200 mg/dL resulted in an LDL-C of 126 mg/dL; a 42% reduction resulted in an LDL-C of 116 mg/dL; a 45% reduction resulted in an LDL-C of 110 mg/dL; and a 53% reduction resulted in an LDL-C of 94 mg/dL.

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.

Reference: 1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 20507091(2)-ZET.

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