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Ezetimibe/atorvastatin

From Wikipedia, the free encyclopedia
Cholesterol medication

Pharmaceutical compound
Ezetimibe/atorvastatin
Combination of
EzetimibeHypolipidemic agent
AtorvastatinStatin
Clinical data
Trade namesLiptruzet, Atozet
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
PubChemCID
KEGG

Ezetimibe/atorvastatin (trade namesLiptruzet,Atozet) is a cholesterol loweringcombination drug.[1] In the United States, it was approved in May 2013, by theFood and Drug Administration for the treatment of elevatedlow-density lipoprotein (LDL) in patients with primary or mixedhyperlipidemia asadjunctive therapy to diet.[2] It has also been approved to reduce elevated total cholesterol and elevated LDL in patients diagnosed with homozygous familial hypercholesterolemia as an adjunctive treatment to other hyperlipidemia treatments.[3]

Some cardiologists opposed the approval, because the combination reduced LDL cholesterol in a clinical trial, but it did not reduce heart disease. A clinical trial studying the endpoints of heart attacks, strokes and heart-related deaths is scheduled to conclude in 2014.[4]

Liptruzet was withdrawn from sale by its manufacturer in June 2015, but not for reasons of safety or effectiveness.[5]

Mechanism of action

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This combination drug works to reduce cholesterol levels through two different pathways. Theezetimibe component of the medication works by inhibiting cholesterol absorption from food while theatorvastatin component inhibits intrinsic cholesterol production in the liver.[6]

Safety

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  • The drug is not safe to use in patients with active liver disease or unexplained persistentelevations in hepatic transaminase.
  • Women that are pregnant or may become pregnant should not use the drug. It is a teratogenic agent that may disrupt the growth and development of a fetus. Immediate discontinuation is recommended in patients that become pregnant while taking this drug.

Adverse effects

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Commonly reported adverse effects include:[7]

  • Musculoskeletal pain
  • Elevated liver enzymes (AST and ALT)
  • Gastrointestinal problems such as abdominal pain and nausea

See also

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References

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  1. ^Ferreira AM, Marques da Silva P (June 2017). "Defining the Place of Ezetimibe/Atorvastatin in the Management of Hyperlipidemia".American Journal of Cardiovascular Drugs.17 (3):169–181.doi:10.1007/s40256-016-0205-0.PMID 27943172.
  2. ^"FDA Approves Merck's LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol".Business Wire. May 6, 2013. RetrievedMay 6, 2013.
  3. ^"Liptruzet." CenterWatch. Web. 28 Oct. 2014.
  4. ^Thomas K (May 3, 2013)."Drug to Cut Cholesterol Is Approved by the F.D.A."New York Times.
  5. ^"Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness".Federal Register. Notice by the Food and Drug Administration. 20 November 2015.
  6. ^Liptruzet [package insert]. Whitehouse Station, NJ: Merck & Co.; 2013
  7. ^Clinical trial numberNCT00418834 for "Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)" atClinicalTrials.gov
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