title: Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients.
abstract: OBJECTIVE
  The goal of the work described here was to explore the efficacy, safety, and tolerability of adjunctive therapy with levetiracetam and associated changes in health-related quality of life in Australian patients with uncontrolled partial seizures.
  
  
  METHODS
  A phase IV open-label 16-week clinical trial was undertaken. Patients received adjunctive levetiracetam, adjusted according to clinical response to a final daily dose of 1000-3000 mg. Seizure frequency and adverse events were recorded. A quality-of-life questionnaire (QOLIE-10-P) was administered at the start and end of therapy.
  
  
  RESULTS
  The intention-to-treat population (N=152) experienced a median reduction in total seizure frequency of 57.7%. The 50% responder rate was 56.6%, and 12.5% of patients were free of seizures throughout the trial. Adverse events were mostly mild or moderate, leading to discontinuation in 9.9%. The most common adverse events were somnolence, fatigue, headache, and dizziness. Behavioral adverse events occurred in approximately one-quarter of patients, including two-thirds of those who withdrew because of adverse events. There was an improvement in the QOLIE-10-P score.
  
  
  CONCLUSIONS
  Levetiracetam is effective and well tolerated when added to existing therapy in patients with uncontrolled partial seizures.
authors.affiliation: Institute of Neurological Sciences, Prince of Wales Hospital, Randwick, NSW, Australia. e.somerville@unsw.edu.au
authors.forename: Ernest R
authors.initials: ER
authors.lastname: Somerville
authors.forename: Daniel B
authors.initials: DB
authors.lastname: McLaughlin
authors.forename: Martin K
authors.initials: MK
authors.lastname: Robinson
authors.forename: Samuel F
authors.initials: SF
authors.lastname: Berkovic
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D001315:Australia / Q000453:epidemiology; D003131:Combined Modality Therapy / Q000379:methods; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes; D010082:Oxepins; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: C461941:1-phenyl-1,4-epoxy-1H,4H-naphtho(1,8-de)(1,2)dioxepin; D000927:Anticonvulsants; D009281:Naphthalenes; D010082:Oxepins; D000077287:Levetiracetam; D010889:Piracetam