- Ballantyne 20041
- Atorvastatin
- Stein 20042
- Atorvastatin
- Stein 20033
- Atorvastatin
- Stein 20033
- Rosuvastatin
- Illingworth 20014
- Atorvastatin
- Illingworth 20014
- Simvastatin
- Stalenhoef 19935
- Simvastatin
- Stalenhoef 19935
- Pravastatin
Important Information About ZETIA
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, and Apo B 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.
When using ZETIA with a statin, also follow the label recommendations for that specific statin.
Selected Cautionary Information: When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (>3 x 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 x 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.
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%), and pain in extremity (2.7% vs 2.5%).
Before prescribing ZETIA, please read the Prescribing Information.
References: 1. Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004;93(12):1487–1494. 2. Stein E, Stender S, Mata P, et al; for 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(3):447–455. 3. Stein EA, Strutt K, Southworth H, Diggle PJ, Miller E; for HeFH Study Group. Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia. Am J Cardiol. 2003;92(11):1287– 1293. 4. Illingworth DR, Crouse JR III, Hunninghake DB, et al; and Simvastatin Atorvastatin HDL Study Group. A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial. Curr Med Res Opin. 2001;17(1):43–50. 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(1):77–82. 6. 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(2)-ZET.
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