As an adjunct to diet when diet alone is not enough, for your patients with hypercholesterolemia
What could get your patients' LDL-C lower?
Consider adding ZETIA for superior LDL-C reduction vs statin titration1-3:
Adding ZETIA vs titration of
specified statins Additional mean percent LDL-C reduction may be achieved when adding ZETIA to statins studied1-3 Explore head-to-head data
Adding ZETIA to
rosuvastatin A clinical trial evaluated the addition of ZETIA to rosuvastatin vs titration of rosuvastatin1 Explore head-to-head data
Adding ZETIA to
simvastatin See how adding ZETIA compared to doubling the dose of simvastatin3 Explore a factorial design study
- • 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.
- SELECTED CAUTIONARY INFORMATION
- • When using ZETIA with a statin, also follow the label recommendations for that specific statin.
- • 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.
- • 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.
- • Because renal impairment is a risk factor for statin-associated myopathy, doses of simvastatin exceeding 20 mg should be used with caution and close monitoring when administered concomitantly with ZETIA in patients with moderate to severe renal impairment (eGFR <60 mL/min/1.73 m2).
- • 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%).
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.