LIPTRUZET (ezetimibe/atorvastatin), fixed combination of cholesterol-lowering drugs
Reason for request
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.
Improvement in actual benefit