Abstracts

Rationale: Once-daily extended-release (XR) formulations of antiepileptic drugs, including Trokendi XR® (Supernus Pharmaceuticals, Inc.), may have potentially favorable effects on effectiveness, retention, and overall outcomes when used in clinical practice. While data from properly executed randomized clinical trials (RCTs) provide the strongest evidence of efficacy and tolerability/safety, medical record review can provide valuable information for clinicians and payers on drug performance in the more diverse populations and conditions of clinical care. Because Trokendi XR was shown to be pharmacokinetically bioequivalent to immediate-release topiramate (Topamax®) and RCTs were not required for FDA approval, this study provides insight into the use of Trokendi XR in patients with epilepsy.Methods: Retrospective HIPAA-compliant review of medical charts of randomly selected patients to collect de-identified patient data. Study approved by central institutional review board. Inclusion: Trokendi XR treatment initiated between 08/2013 and 06/2014 in patients age ≥6 yr; record of Trokendi XR treatment-initiating visit and ≥1 post-initiation visit. Key data: primary diagnosis; patient characteristics; dosage; patient-reported adherence; seizure-related outcomes.Results: A total of 83 patients treated with Trokendi XR had a primary diagnosis of epilepsy. The majority of patients (n=73; 88%) had ≥1 comorbid conditions when Trokendi XR treatment was initiated. The most common comorbid conditions were migraine (n=21, 25%), depression (n=20, 24%); sleep disorders (n=16, 18%); obesity (n=15, 18%); anxiety (n=13, 16%); and/or cognitive problems (n=11, 13%). Median age was 23 yrs (range, 7-62 yrs); 61% were female. Median daily Trokendi XR dose was 200 mg/day (range, 50-850 mg); daily dosage was 200-400 mg/day in 61% of epilepsy patients. Continuation on Trokendi XR at the time of record review: 78%. Median Trokendi XR treatment duration: 335 days. Adverse events (AEs) were reported by 17% (n=14) of patients; most common AEs were somnolence/fatigue (n=5, 6%), moodiness/irritability (n=4; 5%), and decreased attention (n=4, 2%). After Trokendi XR initiation, average monthly seizure frequency was reduced 41% vs. pre-Trokendi XR treatment.Conclusions: This sample of epilepsy patients treated with Trokendi XR in clinical practice was predominantly female and relatively evenly distributed between adults (25-80+ yrs) and children, adolescents, and young adults. Dosages used were consistent with recommended dosages in product labeling. The relatively high continuation/retention rate (78%) is consistent with outcomes when dosages can be adjusted according to clinical response vs. RCTs in which patients are force-titrated to target dosages regardless of clinical need. Study sponsor: Supernus Pharmaceuticals, Inc.