Abstracts

Seizures in adult patients with epilepsy are often well controlled by antiepilepsy drugs (AEDs) though the risk of breakthrough seizures persists. As many as 35% of patients with epilepsy experience inadequate seizure control. The unpredictable nature of breakthrough seizure activity requires a patient to have a rescue medication as part of a comprehensive treatment plan. Diazepam rectal gel is effective in terminating breakthrough seizures with minimal adverse effects, establishing both efficacy and tolerability. Effective control of breakthrough seizures without the necessity of medical intervention may encourage renewed feelings of confidence and empowerment in epilepsy patients. This study examines the ability of diazepam rectal gel to establish effective breakthrough seizure control and tolerability in adult patients with prolonged seizures or seizure clusters. A chart review was conducted to identify adult epilepsy patients who had used diazepam rectal gel for breakthrough seizures in the previous 18 months. Information was collected regarding several aspects of treatment including diagnoses, dose, frequency of use, reasons for use, safety, and efficacy. To assess treatment effectiveness, efficacy in stopping breakthrough seizures in relation to reported adverse events was evaluated. Forty-seven patients received at least 1 dose of diazepam rectal gel. The patient cohort comprised 23 men and 24 women; the mean patient age was 34.7 years (range, 18-59). Diagnoses consisted of partial epilepsy (25 patients), generalized epilepsy (18), multifocal epilepsy (3) and nonepileptic spells (1). Among the patients with generalized epilepsy, 9 were diagnosed with Lennox-Gastaut syndrome. The patient with nonepileptic spells had used rectal diazepam gel before the diagnosis was established, following video-electroencephalogram (EEG) monitoring. The mean diazepam rectal gel dose was .20 mg/kg; the mean total dose was 15.6 mg (range, 10-20 mg). Reasons for use included seizure clusters (26 patients), prolonged seizures (12 patients), or both (9 patients).The frequency of use ranged from once every 4 months to weekly in poorly controlled seizures. Diazepam rectal gel was effective in stopping seizures in 43 patients (91.4%). Somnolence was reported in all patients, although this may partially be due to characteristics of the postictal state. No other AEs and no serious AEs were reported. Diazepam rectal gel demonstrates efficacy and tolerability as a seizure rescue medication for adult patients with a variety of seizure types. Breakthrough seizures were controlled in most patients and repeat use suggests acceptance of mild AEs in favor of effective seizure control. Effective at-home treatment that results in well-controlled seizures suggests the potential for improved patient confidence, ability to expand the activities of daily living, and enhanced quality of life. (Supported by Xcel Pharmaceuticals)