Rectal diazepam gel for treatment of acute repetitive seizures in adults

James Cereghino, James C. Cloyd, Ruben I. Kuzniecky

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy and tolerability of diazepam (DZP) rectal gel (Diastat; Elan Pharmaceuticals, Dublin, Ireland) for the treatment of acute repetitive seizures in adult patients in 2 multicenter, double-blind, placebo-controlled parallel studies. Methods: Ninety-six adults 18 years or older with acute repetitive seizures, 70 of whom received treatment, were randomized into the 2 studies. Active and placebo medications were supplied in prefilled, identical-appearing delivery systems. In study 001, patients received a second dose 4 hours after the initial treatment. Patients in study 003 received only 1 treatment. Patients were observed for 12 hours after the first dose. Results: There was a significant reduction in seizure frequency in patients who received DZP compared with the placebo group. The median number of seizures per hour in the group treated with DZP rectal gel was 0.00, vs 0.13 in the placebo group (P = .002). In addition, significantly more DZP rectal gel - treated patients remained seizure-free during the 12-hour observation period (71% [22/31] vs 28% [11/39]). Using Kaplan-Meier life-table analysis, time to the next seizure was found to be significantly longer in DZP rectal gel - treated than placebo-treated patients (P

Original languageEnglish (US)
Pages (from-to)1915-1920
Number of pages6
JournalArchives of Neurology
Volume59
Issue number12
DOIs
StatePublished - Dec 1 2002

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Diazepam
Seizures
Gels
Placebos
Therapeutics
Life Tables
Ireland
Observation
Placebo
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Rectal diazepam gel for treatment of acute repetitive seizures in adults. / Cereghino, James; Cloyd, James C.; Kuzniecky, Ruben I.

In: Archives of Neurology, Vol. 59, No. 12, 01.12.2002, p. 1915-1920.

Research output: Contribution to journalArticle

Cereghino, James ; Cloyd, James C. ; Kuzniecky, Ruben I. / Rectal diazepam gel for treatment of acute repetitive seizures in adults. In: Archives of Neurology. 2002 ; Vol. 59, No. 12. pp. 1915-1920.
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