Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients

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• 作者：Ernest R. Somerville ; Daniel B. McLaughlin ; Martin K. Robinson ; Samuel F. Berkovic
• 关键词：Levetiracetam ; Adjunctive treatment ; Clinical trial ; Open-label ; Partial seizures ; Refractory epilepsy ; Antiepileptic drug ; Quality of life
• 刊名：Epilepsy & Behavior
• 出版年：2007
• 出版时间：November 2007
• 年：2007
• 卷：11
• 期：3
• 页码：338-342
• 全文大小：113 K

文摘

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.

Conclusion

Levetiracetam is effective and well tolerated when added to existing therapy in patients with uncontrolled partial seizures.