Superior efficacy of new medicines?
OBJECTIVE
To provide an overview of and discuss newly authorised medicines with an improved efficacy.


METHODS
This analysis focussed on new medicines with an improved efficacy based on the results of randomised active control trials. Information on comparative efficacy was obtained from the European Medicines Agency European Public Assessment Reports.


RESULTS
Between 1999 and 2005 we identified 122 new medicines with a new active substance. Of these, 13 (10%) were shown to be superior to already available medicines in terms a statistically significant difference in primary clinical endpoints.


CONCLUSIONS
A proven advantage in efficacy at an early stage of drug development is the exception rather than the rule. The absence of evidence demonstrating differences between medicines does not necessarily mean that there are no actual differences. Optimal pharmacotherapy would benefit from more comparative research in the development of new medicines. The results of comparative trials need to be critically evaluated for their specific value in clinical practice. To this end, prescription data may be helpful.
van Luijn
Johan C F
JC
Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80.082, 3508 TB, Utrecht, The Netherlands.
Gribnau
Frank W J
FW
Leufkens
Hubert G M
HG
D055808:Drug Discovery / Q000639:trends*; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D015507:Drugs, Investigational