As an adjunct to diet when diet alone is not enough, in moderately high-risk or high-risk patients with hypercholesterolemia
What could get your patients' LDL-C lower?
- • 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, Apo B, and non–HDL-C 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.
Mean Treated Baselines1
At other doses, mean LDL-C reduction was 18% for ZETIA + rosuvastatin 5 mg vs 6% for rosuvastatin 10 mg (P
|ZETIA + rosuvastatin 5 mg or 10 mg (pooled)
||104 mg/dL (n=219)
|rosuvastatin 10 mg or 20 mg (pooled)
||100 mg/dL (n=217)
|ZETIA + rosuvastatin 10 mg
||101 mg/dL (n=121)
|rosuvastatin 20 mg
||98 mg/dL (n=121)
|ZETIA + rosuvastatin 5 mg
||107 mg/dL (n=98)
|rosuvastatin 10 mg
||102 mg/dL (n=96)
Mean Treated Baselines2
|ZETIA + atorvastatin 40 mg
||89 mg/dL (n=277)
|atorvastatin 80 mg
||90 mg/dL (n=279)
Mean Untreated Baselines3
Mean incremental LDL-C reduction was 25% for ZETIA/simvastatin 40 mg. Simvastatin 80 mg is a restricted dose and is not a titration dose.
|ZETIA + simvastatin (all doses pooled)
||176 mg/dL (n=609)
|simvastatin (all doses pooled)
||178 mg/dL (n=622)
- SELECTED CAUTIONARY INFORMATION
- • 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%), pain in extremity (2.7% vs 2.5%), and fatigue (2.4% vs 1.5%).
Additional Important Safety Information
Before prescribing ZETIA, please read the Prescribing Information. The Patient Information also is available.
References: 1. Bays HE, Davidson MH, Massaad R, et al. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011;108:523–530. 2. Leiter LA, Bays H, Conard S, et al. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008;102:1495–1501. 3. Bays HE, Ose L, Fraser N, et al. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004;26:1758–1773.