The purpose of these investigations was to determine from combined data the response to rectal diazepam (DZP) gel (Diastat [Athena Neurosciences, South San Francisco, CA]) in home treatment of children with episodes of acute repetitive seizures (ARS). A subset of patients aged 2-17 years were selected from two prospective placebo-controlled studies of children and adults. In both studies a prospective, double-blind, placebo-controlled design was used. The treatment groups (68 DZP; 65 placebo) did not differ significantly in age, race, seizure type or etiology, or in the median number of ARS episodes per month before study entry. DZP-treated children demonstrated a significant reduction in median seizure frequency compared with the placebo group (0.00 vs 0.25 seizures per hour, P = 0.001). Significantly more DZP-treated children remained seizure free during the observation period (40 vs 20, P = 0.001). Somnolence was the only adverse effect present significantly more often in the DZP-treated children (25.0% vs 7.7%, P = 0.0095). There were no instances of serious respiratory depression. Rectal DZP was demonstrated to be an effective and safe treatment to abort an episode of ARS in a child and, additionally, lessened the likelihood of seizure recurrence within the next 12 hours.
Bibliographical noteFunding Information:
The studies reported here were supported by contracts from the Epilepsy Branch, National Institute of Neurological Disorders and Stroke, and Athena Neurosciences, Inc. The authors thank Robert Freeman of Upsher Laboratories, Ilo Leppik, MD of MINCEP, and Tom Rector, PhD of United Health Care, Minneapolis, without those contributions and insight this investigation would not have been possible. The authors are grateful to Walter E. Bell, PhD of the Epilepsy Branch of NINDS for his review of the manuscript. In addition the authors wish to acknowledge the following individuals for their participation in various phases of this involved clinical trial: Lee A. Adelman; Peter A. Ahmann, MD; E. Martina Bebin, MD; Marjorie Berg; Carolyn Belz, CRNP; Sarah Borror, RN; Michael N. Boyd, PhD; Patricia L. Bruno, RN, BS; Debbie Carson, RN; Mary Chu, RN; Susan M. Driscoll-Bannister; William R. Garnett, PhD; Lesley Groves, PhD; Cheryl Hall, RN; Christi Harker, RN; Peggy Hugger; Cherri B. Hughes; Carolyn Jones-Saete, RN; Linda Kraemer, LPN; Ruben I. Kuzniecky, MD; Lorraine Lazar, MD; Warren D. Lo, MD; Susan Melamed, RN, MSN, CRNP; Kim M. Merner; Suzanne O’Donnell Murphy, RN, MSN, CRNP; Kathryn A. O’Hara; Betty Y. Ong, MD; Jan L. Paolini, RN, MS; Frank J. Ritter, MD; Nancy Santilli, MSN, PNP; Gloria Schallert; Roberta Homzie Schlesinger; Cathy Schumer, RN; Paulette Snider, RN; Georgia Thompson, RN; Christie Tilton; Edwin Trevathan, MD; and Dana B. Vrcan.