| Mega-trials: is meta-analysis an alternative? | |
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MedLine Citation:
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PMID: 8834929 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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J Lubsen |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: European journal of clinical pharmacology Volume: 49 Suppl 1 ISSN: 0031-6970 ISO Abbreviation: Eur. J. Clin. Pharmacol. Publication Date: 1996 |
Date Detail:
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Created Date: 1996-12-05 Completed Date: 1996-12-05 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 1256165 Medline TA: Eur J Clin Pharmacol Country: GERMANY |
Other Details:
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Languages: eng Pagination: S29-33 Citation Subset: IM |
Affiliation:
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SOCAR Research SA, Givrins, Switzerland. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angiotensin-Converting Enzyme Inhibitors
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therapeutic use* Heart Failure / drug therapy* Humans Meta-Analysis as Topic* Ramipril / therapeutic use* |
| Chemical | |
Reg. No./Substance:
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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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