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TRANSPARENCY COMMITTEE OPINION

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

Active substance (DCI)
  • ezetimibe/atorvastatin
CARDIOLOGY - New medicinal product

Reason for request
Inclusion

Date 18 February 2015

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.

 

 


Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

Documents

English version

ATC Code
  • C10BA05
Laboratory / Manufacturer
MSD FRANCE

Presentation

-

Posted on Feb 29 2016