Abstracts

New challenges for safe and effective treatment of patients with epilepsy emerge as medical care improves and patients live longer. Elderly patients generally have a greater number of comorbid medical conditions and require more concomitant medications than younger patients. In addition, patients[rsquo] response to a medication alters due to age-related pharmacokinetic and pharmacodynamic changes. Although diazepam rectal gel, a rescue medication for the treatment of breakthrough seizures, has demonstrated an excellent safety and efficacy profile in children and adults, few data regarding safety evaluations specific to the geriatric population are available. As the segment of elderly patients grows to represent an increasing percentage of the epilepsy population, the need for these data will assume increasing importance. To evaluate the safety of diazepam rectal gel use in elderly patients, postmarketing reports of adverse events were reviewed. We evaluated the number and type of adverse events occurring in elderly patients that were spontaneously reported to the MedWatch program of the Food and Drug Administration. Patients aged 61 years and older were included. Projected, age-specific numbers of patients using diazepam rectal gel were estimated from the NDC Health Market Focus Reports. Approximately 6000 patients at least 61 years of age were estimated to have used diazepam rectal gel between 1999 and 2002, inclusive. Of these patients, an estimated 3800 were at least 71 years of age. Among the 40 MedWatch reports for this time period, only 1 adverse event was spontaneously reported in an elderly patient. This patient was an 85-year-old man with a history of diabetes, Parkinson disease, and 2 strokes. Beginning approximately 1 day following a single 10-mg dose of diazepam rectal gel, the patient experienced confusion, disorientation, and forgetfulness for at least 1 week. The absence of any reports of respiratory adverse events, hypotension, or falls with fractures in geriatric diazepam rectal gel users is an important observation. While these data do not capture all adverse events, the relative absence of reported adverse events among patients over the age of 60 provides evidence for the safety of diazepam rectal gel use in elderly patients. (Supported by Xcel Pharmaceuticals)