TREATING REPETITIVE SEIZURES WITH A RECTAL DIAZEPAM FORMULATION - A RANDOMIZED STUDY

Objective: To evaluate the effectiveness and safety of a single-dose t reatment for acute repetitive seizure (ARS) episodes (e.g., clusters) administered in a nonmedical setting by caregivers, Background: Patien ts with epilepsy may experience ARS episodes despite optimal anticonvu lsant treatment. Such episodes require rapid treatment as medical emer gencies. Typically, the patient is treated in an emergency medical set ting with IV medication by trained medical personnel. Methods: The aut hors undertook a multicenter, randomized, parallel, double-blind study of a single administration of Diastat (diazepam rectal gel) for treat ing 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 a nd adverse events. Results: A total of 29 centers enrolled 158 patient s, of whom 114 patients had a treated ARS episode (Diastat, n = 56; pl acebo, n = 58). Diastat treatment reduced median seizure frequency (p = 0.029), More Diastat patients were seizure free post-treatment (Dias tat, 55%; placebo, 34%; p = 0.031). Kaplan-Meier analysis of the time to the next seizure favored Diastat treatment (p < 0.007). The most co mmon adverse event was somnolence. Conclusion: Administration of a sin gle rectal dose of Diastat was significantly more effective than place bo in reducing the number of seizures following an episode of ARS. Car egivers could administer treatment safely and effectively in a nonmedi cal setting.