Document Detail


Mega-trials: is meta-analysis an alternative?
MedLine Citation:
PMID:  8834929     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
J Lubsen
Related Documents :
19374739 - How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group ...
9489259 - Defining empirically supported therapies.
21292059 - Acceptance and commitment therapy for generalized anxiety disorder in older adults: a p...
8945689 - Effect of physician profiling on utilization. meta-analysis of randomized clinical trials.
21560159 - Effects of non-steroidal anti-inflammatory drug treatments on cognitive decline vary by...
21556489 - Health-related quality of life in patients with chagas disease.
8789649 - Life events and symptomatic recovery of army spouses following operation desert storm.
11584839 - Psychological reactions and quality of life in patients with posterior uveal melanoma t...
20461089 - Patient satisfaction with gp-led melanoma follow-up: a randomised controlled trial.
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    
Affiliation:
SOCAR Research SA, Givrins, Switzerland.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
Heart Failure / drug therapy*
Humans
Meta-Analysis as Topic*
Ramipril / therapeutic use*
Chemical
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


Previous Document:  ACE inhibitors before or after heart failure?
Next Document:  What have the ACE-inhibitor trials in postmyocardial patients with left ventricular dysfunction taug...