- 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
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. 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;93:1487–1494. 2. 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. 3. Stein EA, Strutt K, Southworth H, Diggle PJ, Miller E, for the HeFH Study Group. Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia. Am J Cardiol. 2003;91:1287– 1293. 4. Illingworth DR, Crouse JR III, Hunninghake DB, et al, and the 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;17:43–50. 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;234:77–82.
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