Abstracts

Rationale: Indications, dosing, and preliminary side effect information for antiepileptic drugs (AEDs) are obtained from initial clinical trials, however, a wealth of additional information is obtained from their use in clinical practice. The Postmarketing Antiepileptic Drug/Device Survey (PADS) was developed to allow for standardized data collection including medication usage, titration schedule, adverse effects, and drug interactions. The present review summarizes current PADS clinical data following the release of Pregabalin (PGB) in 2005. Methods: The PADS data was collected at 12 large metropolitan epilepsy clinics during 2005 and 2006. Initial surveys were completed prospectively by the clinician and, therefore, had no direct effect on clinical practice. For inclusion in this analysis, at least one follow up survey was required along with the completion of an initial survey. Results: Forty-six patients (20 females, 25 males, 1 not recorded) had at least one follow up survey completed for the after their initial PADS survey when they were started on PGB. Patient ages ranged from 19 to 63 years (M = 41, SD = 12.24 ) and age of onset ranged from 4 months to 46 years old (M = 16, SD = 13.89). Prior to initiation of PGB therapy, 15% of patients (n = 7) reported experiencing simple partial seizures, 39% (n = 18) reported complex partial seizures, and 17% reported both seizure types (n = 8). At the time of the initial PADS survey, the number of concurrent AEDs ranged from 1 to 5 (M = 2.89, SD = 1.05). Three-month follow up survey was available for 46 participants, and 43.5% of patients (n = 20) reported improvement in their seizure status, 30.4% (n = 14) reported no significant change, 19.6% (n = 9) reported worsening and seizure assessment unknown for 6.5% of patients (n = 3). Fatigue was the most common complaint; reported in 33% of patients (n = 15), ranging in severity from mild (n = 5) to worthy of discontinuing PGB (n = 5). PGB was discontinued in 35% (n = 16) at the 3-month follow up, with 10 due to lack of efficacy (LOE) and 6 for adverse events (AE). A six-month follow up was completed for 24 of the 30 remaining patients. Improved seizure control was reported in 45.8% participants (n = 11), whereas 16.7% (n = 4) remained the same, 29.2% (n = 7) worsened, and 8.3% (n = 2) were unreported. PGB was discontinued in 4 patients (3 LOE, 1 AE). Conclusions: Pregabalin is an effective and reasonably tolerated adjunctive agent based on the data collected by PADS at 3 and 6-months duration of therapy. Enrollment will increase over time and will supply increasing information on patient responses outside registration provided studies.