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Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease.

Am J Cardiol. 2008;102:1489–1494.

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[EXE: 3.61 MB, 6 pages]

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.

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[EXE: 3.70 MB, 7 pages]

Stein E, Stender S, Mata P, et al.

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.

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[PDF: 210 KB, 9 pages]

Ballantyne CM, Houri J, Notarbartolo A, et al.

Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial.

Circulation. 2003;107:2409–2415.

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[PDF: 256 KB, 7 pages]

Gagné C, Bays HE, Weiss SR, et al.

Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia.

Am J Cardiol. 2002;90:1084–1091.

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[PDF: 285 KB, 8 pages]

Farnier M, Freeman MW, Macdonell G, et al.

Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia.

Eur Heart J. 2005;26:897–905.

McKenney JM, Farnier M, Lo K-W, et al.

Safety and efficacy of long-term coadministration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia.

J Am Coll Cardiol. 2006;47:1584–1587.

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[PDF: 221 KB, 13 pages]

Turley SD, Dietschy JM.

The intestinal absorption of biliary and dietary cholesterol as a drug target for lowering the plasma cholesterol level.

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[PDF: 2,275 KB, 7 pages]

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults.

Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).

JAMA. 2001;285:2486–2497.

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[PDF: 248 KB, 11 pages]

 

 

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	The effects of ZETIA, either alone or in addition to a statin or fenofibrate, on the risk of cardiovascular morbidity and mortality have not been established.
	ZETIA administered in combination with fenofibrate is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, Apo B, and non–HDL-C in adult patients with mixed hyperlipidemia when diet alone is not enough.
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%).
	Incidence rates (95% CI) for clinically important elevations (≥3 × ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for fenofibrate monotherapy (n=188) and ZETIA coadministered with fenofibrate (n=183), respectively, adjusted for treatment exposure.
	When ZETIA was coadministered with fenofibrate, incidence rates for cholecystectomy were 0.6% and 1.7% for fenofibrate monotherapy and ZETIA coadministered with fenofibrate, respectively.

Before prescribing ZETIA, please read the Prescribing Information.

For non-US health care professionals, click here.

               

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