ZETIA (ezetimibe)

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Important Information About ZETIA
PRAVASTATIN – Stalenhoef 1993(5) A Titration Step Delivered LIMITED LDL-C Reduction

Examine Additional Statin Titration Studies

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Study Design5: An 18-week, double-blind, randomized, parallel-group study in patients (N=48) with primary hypercholesterolemia (LDL-C >179 mg/dL and triglycerides <409 mg/dL). Patients were randomized to either simvastatin 10 mg or pravastatin 10 mg. Therapies were titrated to the next highest dose every 6 weeks (up to 40 mg), unless LDL-C was <131 mg/dL at the end of Week 12. The objective of this study was to compare the efficacy of increasing doses of simvastatin and pravastatin. Mean baseline LDL-C was 316 mg/dL and 313 mg/dL for the simvastatin and pravastatin groups, respectively.
 
Mean LDL-C reductions from baseline were 32% vs 23% for simvastatin 10 mg vs pravastatin 10 mg (P<0.001 vs baseline for both). Mean LDL-C reductions from baseline were 40% vs 26% (P<0.01 simvastatin 20 mg vs pravastatin 20 mg). Mean LDL-C reduction from baseline was 43% for simvastatin 40 mg vs 33% for pravastatin 40 mg (P<0.01).
 
Additional LDL-C reduction provided by titration of simvastatin 10 mg to 20 mg was 8% (P<0.01) and from simvastatin 20 mg to 40 mg was 3%, corresponding to mean additional LDL-C reductions of 23 mg/dL and 10 mg/dL, respectively. Additional LDL-C reduction provided by titration of pravastatin 10 mg to 20 mg was 3% and from pravastatin 20 mg to 40 mg was 7% (P<0.05), corresponding to additional mean LDL-C reductions of 13 mg/dL and 21 mg/dL, respectively. Simvastatin 80 mg was not available at the time of the study. The additional percent reductions in LDL-C and the corresponding mean additional LDL-C reductions with successive doses were obtained by subtraction from data presented.

Important Information About ZETIA

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) hypercholesterolemia when diet alone is not enough.

Contraindications: hypersensitivity to any component of this medication.
Contraindications when used with a statin: active liver disease; unexplained persistent elevations of serum transaminases. 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.

The effects of ZETIA, either alone or in addition to a statin, on the risk of cardiovascular morbidity and mortality have not been established.

Selected Cautionary Information: When ZETIA was coadministered with a statin, consecutive elevations in serum transaminases (≥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.

Patients should be advised to promptly report muscle pain, tenderness, or weakness. Discontinue drug if myopathy is diagnosed or suspected.

ZETIA is not recommended in patients with moderate or severe hepatic insufficiency.

The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is 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, the most frequent side effects for ZETIA alone vs placebo included back pain (4.1% vs 3.9%), arthralgia (3.8% vs 3.4%), and fatigue (2.2% vs 1.8%); for ZETIA + statin vs statin or placebo alone: back pain (4.3% vs 3.7% vs 3.5%), abdominal pain (3.5% vs 3.1% vs 2.3%), and fatigue (2.8% vs 1.4% vs 1.9%).

Before prescribing ZETIA, please read the Prescribing Information and Patient Product Information.

Reference: 5. Stalenhoef AFH, Lansberg PJ, Kroon AA, et al. Treatment of primary hypercholesterolaemia. Short-term efficacy and safety of increasing doses of simvastatin and pravastatin: a double-blind comparative study. J Intern Med. 1993;234:77–82.

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