Document Detail


Nimodipine in traumatic subarachnoid haemorrhage: a re-analysis of the HIT I and HIT II trials.
MedLine Citation:
PMID:  8955434     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Two large randomised controlled trials have been performed to study the effect of the calcium antagonist nimodipine on the outcome of severe head injury, HIT I [1] amd HIT II [4]. Both trials showed a modest and statistically non-significant increase in the proportion of favourable outcomes in patients treated with nimodipine. A subgroup analysis of the HIT II trial [4, 5] suggested, however, that there could be a substantial protective effect of nimodipine in patients with traumatic subarachnoid haemorrhage (SAH). This report provides a re-analysis of the HIT I data to see whether it provides a re-analysis of the HIT I data to see whether in HIT II. This involved performing a central review of the CT scans for the HIT I patients, to identify those individuals with evidence of traumatic SAH. The sample size was small, but the HIT I data gave no support to the hypothesis that nimodipine is protective in the traumatic SAH subgroup, where 69% of patients had a poor outcome on placebo and 74% of patients had a poor outcome on nimodipine. The data do not exclude the possibility of a clinically relevant beneficial effect of nimodipine in the traumatic SAH subgroup, but further data are required to provide a definitive answer. In addition, we present a pooled analysis of the data from the two trials, which suggests that the overall benefit of treating unselected head injured patients with nimodipine is unlikely to be clinically relevant.
Authors:
G D Murray; G M Teasdale; H Schmitz
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Publication Detail:
Type:  Clinical Trial; Journal Article; Meta-Analysis; Randomized Controlled Trial    
Journal Detail:
Title:  Acta neurochirurgica     Volume:  138     ISSN:  0001-6268     ISO Abbreviation:  Acta Neurochir (Wien)     Publication Date:  1996  
Date Detail:
Created Date:  1997-03-18     Completed Date:  1997-03-18     Revised Date:  2009-11-11    
Medline Journal Info:
Nlm Unique ID:  0151000     Medline TA:  Acta Neurochir (Wien)     Country:  AUSTRIA    
Other Details:
Languages:  eng     Pagination:  1163-7     Citation Subset:  IM    
Affiliation:
Robertson Centre for Biostatistics, University of Glasgow, Federal Republic of Germany.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Brain Damage, Chronic / drug therapy,  mortality
Brain Injuries / drug therapy*,  mortality
Calcium Channel Blockers / adverse effects,  therapeutic use*
Female
Glasgow Coma Scale
Humans
Male
Middle Aged
Multicenter Studies as Topic
Nimodipine / adverse effects,  therapeutic use*
Randomized Controlled Trials as Topic
Subarachnoid Hemorrhage / drug therapy*,  mortality
Survival Analysis
Treatment Outcome
Chemical
Reg. No./Substance:
0/Calcium Channel Blockers; 66085-59-4/Nimodipine

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


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