LIPTRUZET (ezetimibe/atorvastatin), fixed combination of cholesterol-lowering drugs

CARDIOLOGY - New medicinal product
Opinions on drugs - Posted on Feb 29 2016

Reason for request

Inclusion

No clinical benefit demonstrated when compared with taking its two components separately

 

  •  LIPTRUZET has a Marketing Authorisation, as adjunctive therapy to diet, in adults with hypercholesterolaemia (heterozygous or homozygous familial, or non-familial) or mixed dyslipidaemia when the ezetimibe + atorvastatin combination is indicated.
  • The efficacy of the combination (free or fixed) of ezetimibe with atorvastatin has been demonstrated only on a biological criterion, the reduction of LDL cholesterol (LDL-c) levels.
  • The efficacy in terms of morbidity and mortality has not been demonstrated to date.
  • No clinical data studying the efficacy of the fixed combination is currently available.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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