Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients.
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.
Somerville
Ernest R
ER
Institute of Neurological Sciences, Prince of Wales Hospital, Randwick, NSW, Australia. e.somerville@unsw.edu.au
McLaughlin
Daniel B
DB
Robinson
Martin K
MK
Berkovic
Samuel F
SF
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
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