Document Detail


Treating repetitive seizures with a rectal diazepam formulation: a randomized study. The North American Diastat Study Group.
MedLine Citation:
PMID:  9818845     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the effectiveness and safety of a single-dose treatment for acute repetitive seizure (ARS) episodes (e.g., clusters) administered in a nonmedical setting by caregivers. BACKGROUND: Patients with epilepsy may experience ARS episodes despite optimal anticonvulsant treatment. Such episodes require rapid treatment as medical emergencies. Typically, the patient is treated in an emergency medical setting with i.v. medication by trained medical personnel. METHODS: The authors undertook a multicenter, randomized, parallel, double-blind study of a single administration of Diastat (diazepam rectal gel) for treating episodes of ARS. ARS episodes and treatment criteria were defined for each patient at the start of the study. Caregivers were taught to determine ARS episode onset, administer a predetermined dose of study medication, monitor outcome, count respirations, and record seizures and adverse events. RESULTS: A total of 29 centers enrolled 158 patients, of whom 114 patients had a treated ARS episode (Diastat, n = 56; placebo, n = 58). Diastat treatment reduced median seizure frequency (p = 0.029). More Diastat patients were seizure free post-treatment (Diastat, 55%; placebo, 34%; p = 0.031). Kaplan-Meier analysis of the time to the next seizure favored Diastat treatment (p < 0.007). The most common adverse event was somnolence. CONCLUSION: Administration of a single rectal dose of Diastat was significantly more effective than placebo in reducing the number of seizures following an episode of ARS. Caregivers could administer treatment safely and effectively in a nonmedical setting.
Authors:
J J Cereghino; W G Mitchell; J Murphy; R L Kriel; W E Rosenfeld; E Trevathan
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Neurology     Volume:  51     ISSN:  0028-3878     ISO Abbreviation:  Neurology     Publication Date:  1998 Nov 
Date Detail:
Created Date:  1998-12-03     Completed Date:  1998-12-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1274-82     Citation Subset:  AIM; IM    
Affiliation:
Oregon Health Sciences University, Portland 97201-3098, USA.
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Administration, Rectal
Adolescent
Anticonvulsants / administration & dosage,  therapeutic use*
Child
Diazepam / administration & dosage,  therapeutic use*
Double-Blind Method
Electroencephalography
Female
Gels
Humans
Male
Recurrence
Respiration
Seizures / drug therapy*,  physiopathology
Chemical
Reg. No./Substance:
0/Anticonvulsants; 0/Gels; 439-14-5/Diazepam

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


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