A unique gel formulation of diazepam safely reduces the severity of acute repetitive seizure episodes in both children and adults, according to a study published in the June 25, 1998, issue of The New England Journal of Medicine* and funded by the National Institute of Neurological Disorders and Stroke (NINDS). Acute repetitive seizures are episodes of multiple seizures that differ from the individual's usual seizure pattern and are often distinctly recognizable by the patient's family and caregivers. The repetitive seizures may occur serially or in clusters and may last minutes to hours. Acute repetitive seizures may require emergency treatment, especially if they progress to status epilepticus, a potentially fatal condition in which a seizure is sustained.
Seizures occur as a result of abnormal electrical activity in the brain. Epilepsy, a common neurological disorder marked by repeated seizures, affects more than 2 million Americans. Benzodiazepines, a class of drugs that includes diazepam and lorazepam, are generally agreed to be the treatment of choice for acute repetitive seizures.
"This new method of treatment clearly reduces the number of seizures for both children and adults and protects patients from seizure recurrence," said Philip H. Sheridan, M.D., Chief of the NINDS Epilepsy Branch. "Informed caregivers are often able to recognize the onset of a seizure cluster. Now, with this preparation, they can be trained to administer treatment privately, quickly, and safely."
The study was a randomized, double-blind study of 91 individuals with acute repetitive seizures. It was conducted by investigators collaborating at ten university medical centers nationwide. The NINDS provided support to six of the 10 centers participating in the Rectal Administration of Diazepam for Acute Repetitive Seizures (RADARS) study. A frequently reported side effect was sleepiness, common to most medicines used to treat epilepsy.
The new preparation is marketed in a Quick-Dose (TM) delivery system as Diastatâ (diazepam rectal gel) by Athena Neurosciences, Inc., a company based in South San Francisco. In addition to the new gel formulation, administered with an applicator, diazepam is also sold in oral form. Administration of diazepam in oral form is problematic for both physicians and family members because the patient must be alert in order to swallow.
"This is a safe and effective way of addressing an urgent health condition and one that enables flexible, convenient treatment outside of a hospital or clinic, including the patient's home," says Dr. Sheridan. "This trial is a striking example of how a relatively small research investment, in this case about $850,000, will save American families substantial amounts of money by enabling patients to stay out of hospital emergency rooms and to receive treatment in their homes. It is also an excellent example of collaboration between a private company, clinical investigators, and the National Institutes of Health in order to meet a medical need."
The NINDS, one of the National Institutes of Health located in Bethesda, Maryland, is the nation's leading supporter of research on the brain and the nervous system and a lead agency for the Congressionally designated Decade of the Brain.
*Dreifuss, F.E. [deceased], Rosman, N.P., Cloyd, J.C., Pellock, J.M., Kuzniecky, R.I., Lo, W.D., Matsuo, F., Sharp, G.B., Conry, J.A., Bergen, D.C., Bell, W.E. "A Comparison of Rectal Diazepam Gel and Placebo for Acute Repetitive Seizures." The New England Journal of Medicine, June 25, 1998, Vol. 338, No. 26, pp. 1869-1875.
This release will be available on the World Wide Web at http://www.ninds.nih.gov.
Journal
New England Journal of Medicine