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
PRAVASTATIN – Stalenhoef 1993(5) 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.
SELECTED CAUTIONARY INFORMATION
bullet gif ZETIA is not recommended in patients with moderate to severe hepatic impairment.
bullet gif The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
bullet gif Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
bullet gif ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
bullet gif 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%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%).

Before prescribing ZETIA, please read the Prescribing Information.

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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 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% for simvastatin 20 mg vs pravastatin 20 mg (P<0.01). 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.

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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21050228(1)-06/10-ZET