title: An open-label, add-on study of pregabalin in patients with partial seizures: a multicenter trial in Greece.
abstract: BACKGROUND
  Pregabalin efficacy and safety as an adjunctive treatment for partial seizures was evaluated using an open-label, flexible-dose.
  
  
  METHODS
  In 98 adults with refractory partial epilepsy taking 1-3 anti-epileptic drugs with ≥2 seizures during an 8-week baseline period.
  
  
  METHODS
  Pregabalin was increased to ≤600 mg/day during a 9-week dose optimization period with dosage maintained for 12 additional weeks. Primary endpoint was the percentage change in partial seizure frequency between the 8-week baseline and 12-week observation period.
  
  
  RESULTS
  Pregabalin treatment was associated with a significant reduction in partial seizure frequency: median percent change in partial seizure frequency from baseline to 12 weeks was -33% and -22% in patients with a baseline seizure frequency of ≤3 and >3 per 28 days, respectively. The 50% and 75% responder rates were 41.94% (95% CI: 31.91-51.96) and 30.11% (95% CI: 20.78-39.43), respectively. Nineteen percent of subjects were seizure-free throughout the last 12 weeks. Pregabalin administration resulted in a significant reduction in anxiety (mean reduction in Hospital Anxiety and Depression Scale scores of 1.68 units, 95% CI: -2.60 to -0.76). Most patients were much improved or very much improved on Patient Global Impression of Change (53.8%) and Clinical Global Impression of Change (53.8%). The most frequently self-reported adverse events (AEs) were mild or moderate somnolence (20.4%) and dizziness (5.1%) with a low AE discontinuation rate (5.1%).
  
  
  CONCLUSIONS
  The efficacy and side-effect profile of pregabalin were similar to previous pregabalin double-blind, controlled studies. Additionally, pregabalin, as an add-on treatment for partial epilepsy, exhibits significant anti-anxiety properties.
authors.affiliation: B'Department of Neurology, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece. stet@med.auth.gr
authors.forename: Stefanos
authors.initials: S
authors.lastname: Tsounis
authors.forename: Vasilios K
authors.initials: VK
authors.lastname: Kimiskidis
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Kazis
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Gkiatas
authors.forename: Kyriakos
authors.initials: K
authors.lastname: Garganis
authors.forename: Klimentini
authors.initials: K
authors.lastname: Karageorgiou
authors.forename: Stylianos
authors.initials: S
authors.lastname: Giannakodimos
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Papathanasopoulos
authors.forename: Andreas
authors.initials: A
authors.lastname: Plaitakis
authors.forename: Alexandros
authors.initials: A
authors.lastname: Papadimitriou
authors.forename: Leonidas
authors.initials: L
authors.lastname: Lyras
authors.forename: Birol
authors.initials: B
authors.lastname: Emir
mesh_terms: D000277:Adjuvants, Pharmaceutic / Q000009:adverse effects / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D004334:Drug Administration Schedule; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000453:epidemiology*; D005260:Female; D006115:Greece / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069583:Pregabalin; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000277:Adjuvants, Pharmaceutic; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid