Evaluating the primary end point over the 14-week study duration, 22% reached protocol-specified LDL-C goal (≤100 mg/dL) with ZETIA + titrated atorvastatin (up to 40 mg) vs 7% with titrated atorvastatin monotherapy (up to 80 mg).
*ZETIA + atorvastatin 10 mg vs atorvastatin 80 mg (Week 4 vs Week 14); P<0.01.
- Mean additional LDL-C reductions at Week 9 were 15% in the group receiving atorvastatin monotherapy (27 mg/dL) vs 30% in the group receiving ZETIA + atorvastatin 20 mg (58 mg/dL).2
- Mean additional LDL-C reductions at Week 14 were 19% in the group receiving atorvastatin monotherapy (37 mg/dL) vs 32% in the group receiving ZETIA + atorvastatin 40 mg (65 mg/dL).2
Study Design1: A 14-week, double-blind study (N=621) of patients with heterozygous familial hypercholesterolemia, coronary heart disease, or ≥2 cardiovascular risk factors and LDL-C ≥130 mg/dL on atorvastatin 10 mg. This study compared LDL-C efficacy with response-based titration of atorvastatin 10 mg to 80 mg vs adding ZETIA followed by response-based titration of atorvastatin 10 mg to 40 mg. Mean treated baselines were 186 mg/dL (ZETIA + atorvastatin 10 mg) and 187 mg/dL (atorvastatin monotherapy). Percent changes in LDL-C correspond to mean additional LDL-C reductions of 43 mg/dL with ZETIA + atorvastatin 10 mg, 16 mg/dL with atorvastatin titrated from 10 mg to 20 mg.
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.
References: 1. Stein E, Stender S, Mata P, et al, for the Ezetimibe Study Group. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatin. Am Heart J. 2004;148:447–455. 2. 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 20705526(1)-ZET.
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