Abstracts

Rationale: In pivotal studies of adjunctive lacosamide (LCM) in adults, treatment-resistant patients on 1-3 concomitant antiepileptic drugs (AEDs) were enrolled. This non-interventional study (NCT01098162) evaluated seizure control and tolerability of adjunctive LCM in patients with POS receiving one concomitant baseline AED. To reflect actual medical care of epilepsy patients, study sites were chosen across the spectrum of office-based neurologists (ON), hospital-based neurologists (HN) and specialized epilepsy centers (EC). This pre-specified analysis was conducted to document patient baseline characteristics and treatment patterns in the physician's clinical practice, and the impact on seizure control and safety of LCM. Methods: This 6-month observational study was conducted in Germany. To mirror the actual medical care of epilepsy in Germany, ON, HN, and specialized EC were targeted at a ratio of 6(ON):1(HN) and 4(ON):1(EC). Outcome variables included changes in seizure frequency (≥50% and ≥75% responder and seizure freedom rates) at last study visit (6 months) compared with a 3-month retrospective baseline, as well as adverse events (AEs). All analyses are descriptive. Results: 112 centers and investigators participated, categorized as ON (86), HN (14) and EC (12), nearly mirroring the planned distribution. Of 573 patients enrolled, 571 were evaluable for safety, 520 for seizure control (FAS), and 499 were treated with in-label doses at any time (mFAS). ON, HN, EC enrolled 393/573 (68.6%) patients, 56/573 (9.8%) patients and 124/573 (21.6%) respectively. Marked differences in demographics were observed (Table 1) between EC and ON for number of previous AEDs, epilepsy duration, and mean seizure frequency at baseline, indicating a more refractory population treated by EC. Baseline treatment patterns also showed marked differences, with the largest difference observed for levetiracetam as the most frequently taken baseline AED for HN and EC in more than 45% of patients, compared with 27.5% for ON. Efficacy results (mFAS) are shown in Figure 1. During the final 3 months of the study, 31.0%, 38.0% and 50.9% of patients treated by EC, HN and ON, respectively, were seizure free. In total, AEs were reported in 48.5% of patients, 28.7% of whom experienced AEs considered related to LCM by the physician. EC and HN reported more related AEs than ON, in 47.5%, 58.9% and 26.7% of patients, respectively. For all three center types, dizziness and fatigue were the most frequently observed AEs. 81.3% of the patients completed the study; 18.9%, 8.9% and 8.4% treated by EC, HN and ON, respectively, discontinued due to an AE. Conclusions: LCM improved seizure control in routine clinical practice when added to one baseline AED, irrespective of the physician's specialization. Differences in efficacy may be explained by differences in baseline demographics between patients in different center types. Treatment with LCM was generally well tolerated. Funded by UCB Pharma