Ezetimibe/atorvastatin

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

Ezetimibe/atorvastatin (trade names Liptruzet, Atozet) is a cholesterol lowering combination drug. In the United States, it was approved in May 2013, by the Food and Drug Administration for the treatment of elevated low-density lipoprotein (LDL) in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet.[1] 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.[2]

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.[3]

Liptruzet was withdrawn from sale by its manufacturer in June 2015, but not for reasons of safety or effectiveness.[4]

  1. ^ "FDA Approves Merck's LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol". Business Wire. May 6, 2013. Retrieved May 6, 2013.
  2. ^ "Liptruzet." CenterWatch. Web. 28 Oct. 2014.
  3. ^ Drug to Cut Cholesterol Is Approved by the F.D.A. By Katie Thomas, New York Times, May 3, 2013
  4. ^ 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Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Federal Register: Notice by the Food and Drug Administration on 11/20/2015.