title: Conversion to eslicarbazepine acetate monotherapy: A pooled analysis of 2 phase III studies.
abstract: OBJECTIVE
  To assess the efficacy and safety of eslicarbazepine acetate (ESL) monotherapy.
  
  
  METHODS
  This post hoc pooled analysis of 2 randomized double-blind studies (093-045 and -046) included adults with partial-onset seizures medically uncontrolled by 1 or 2 antiepileptic drugs (AEDs). Following the baseline period (8 weeks), eligible patients were randomized 2:1 to receive ESL 1,600 mg or 1,200 mg once daily for 18 weeks; the primary endpoint was study exit by meeting predefined exit criteria (signifying worsening seizure control). In each study, treatment was considered effective if the upper 95% confidence limit for exit rate was lower than the historical control threshold (65.3%).
  
  
  RESULTS
  Pooled exit rates were as follows: ESL 1,600 mg = 20.6% (95% confidence interval: 15.6%-26.8%); ESL 1,200 mg = 30.8% (23.0%-40.5%). Use of 2 baseline AEDs or rescue medication, US location, epilepsy duration ≥20 years, and higher maximum baseline seizure frequency were associated with higher exit risks. Median percent reductions in standardized seizure frequency between baseline and the 18-week double-blind period were as follows: ESL 1,600 mg = 43.2%; ESL 1,200 mg = 35.7%; baseline carbamazepine use was associated with smaller reductions. Safety profiles were similar between ESL doses.
  
  
  CONCLUSIONS
  Exit rates for ESL monotherapy (1,600 mg and 1,200 mg once daily) were lower than the historical control threshold, irrespective of baseline AED use and region, with no additional safety concerns identified. Clinical factors and location clearly influence treatment responses in conversion-to-monotherapy trials.
  
  
  METHODS
  This pooled analysis provides Class IV evidence that for adults with medically uncontrolled partial-onset seizures, ESL monotherapy is well tolerated and effective.
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA. michael.sperling@jefferson.edu.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Sperling
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: French
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA.
authors.forename: Mercedes P
authors.initials: MP
authors.lastname: Jacobson
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA.
authors.forename: Ladislav
authors.initials: L
authors.lastname: Pazdera
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA.
authors.forename: Mallory
authors.initials: M
authors.lastname: Gough
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA.
authors.forename: Hailong
authors.initials: H
authors.lastname: Cheng
authors.affiliation: From Thomas Jefferson University (M.R.S.), Philadelphia, PA; New York University Comprehensive Epilepsy Center (J.F.), New York, NY; Department of Neurology (M.P.J.), Temple University School of Medicine, Philadelphia, PA; Vestra Clinics s.r.o. (L.P.), Rychnov nad Kneznou, Czech Republic; FireKite (M.G.), Macclesfield, UK; and Sunovion Pharmaceuticals Inc. (H.C., T.G., D.B), Marlborough, MA.
authors.forename: Todd
authors.initials: T
authors.lastname: Grinnell
authors.forename: David
authors.initials: D
authors.lastname: Blum
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D003984:Dibenzazepines / Q000627:therapeutic use*; D004827:Epilepsy / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D003984:Dibenzazepines; C416835:eslicarbazepine acetate