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Abstract Details

Safety and Tolerability of Eslicarbazepine Acetate as First Adjunctive Therapy with Levetiracetam or Lamotrigine, or as Later Adjunctive Therapy in Patients with Focal Seizures
Epilepsy/Clinical Neurophysiology (EEG)
P9 - Poster Session 9 (12:00 PM-1:00 PM)
12-003

To evaluate safety and tolerability of eslicarbazepine acetate (ESL) as a first adjunctive therapy with levetiracetam (LEV) or lamotrigine (LTG) monotherapy, or as later adjunctive therapy in treatment-resistant patients with focal seizures; efficacy data are reported by Pikalov et al.
ESL is a once-daily, oral antiepileptic drug (AED) that has been shown to be effective and well tolerated for focal seizures in a number of clinical trials, including as adjunctive therapy in treatment-resistant patients.
A multicenter, open-label, non-randomized study of adjunctive ESL in patients aged ≥18 years with focal seizures (NCT03116828). Arm 1: ESL as first adjunctive therapy with LEV (n = 28) or LTG (n = 14). Arm 2: ESL as a later adjunctive therapy, following prior use of 1–2 AEDs (n = 59). The trial comprised screening (1–2 weeks), titration (2 weeks), maintenance (24 weeks), and ESL taper/safety follow-up (4 weeks) periods.
The safety population included 102 patients (Arm 1: n = 43; Arm 2: n = 59). Treatment-emergent adverse events (TEAEs) were reported more frequently in Arm 2 (81.4%) than Arm 1 (69.8%). The most frequently reported TEAEs were dizziness, nausea, headache, somnolence, and fatigue. In Arm 1, TEAEs were reported more frequently in patients who were taking ESL in combination with LTG (92.9%) vs LEV (57.1%). In Arm 2, the incidence of TEAEs was comparable between patients taking ESL in combination with LTG (76.2%) or LEV (75.0%).
ESL was generally safe and well tolerated as a first adjunctive therapy with LEV or LTG monotherapy, or as a later adjunctive therapy for focal seizures. TEAEs were more frequent in patients taking ESL as a later therapy and included dizziness, nausea, headache, somnolence and fatigue, among others. 
Authors/Disclosures
David Cantu, PhD (Xenon Pharmaceuticals Inc)
PRESENTER 		Dr. Cantu has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
Barry E. Gidal, PhD Dr. Gidal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai . Dr. Gidal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Greenwich. Dr. Gidal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for SK life sciences . Dr. Gidal has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Dr. Gidal has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for SK life science .
No disclosure on file
No disclosure on file
Andrei Pikalov No disclosure on file
Todd Grinnell, PhD Todd Grinnell, PhD has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..