Document Detail

Mega-trials: is meta-analysis an alternative?
MedLine Citation:
PMID:  8834929     Owner:  NLM     Status:  MEDLINE    
Large scale placebo-controlled trials with clinical end-points are not possible when other compounds with proven efficacy are already available. Hence, the question arises whether the available experience from placebo-controlled phase III trials can be analysed jointly to assess whether an effect on clinical end-points exists. This question was answered for the new ACE inhibitor ramipril, with which five exercise capacity trials were done in similar patients with heart failure. Meta-analysis showed that ramipril reduced the occurrence of the combined event death or hospitalisation by 32% (P = 0.05), based on the customary 'intention-to-treat' comparison for large scale trials. From this analysis, the lesson has been learnt that a drug development programme must be carefully planned to allow for this type of meta-analysis.
J Lubsen
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of clinical pharmacology     Volume:  49 Suppl 1     ISSN:  0031-6970     ISO Abbreviation:  Eur. J. Clin. Pharmacol.     Publication Date:  1996  
Date Detail:
Created Date:  1996-12-05     Completed Date:  1996-12-05     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  1256165     Medline TA:  Eur J Clin Pharmacol     Country:  GERMANY    
Other Details:
Languages:  eng     Pagination:  S29-33     Citation Subset:  IM    
SOCAR Research SA, Givrins, Switzerland.
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MeSH Terms
Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
Heart Failure / drug therapy*
Meta-Analysis as Topic*
Ramipril / therapeutic use*
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 87333-19-5/Ramipril

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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