UTILITY OF ADJUNCTIVE LAMOTRIGINE THERAPY FOR SEIZURE CONTROL IN A COMMUNITY NEUROLOGY SETTING
Abstract number :
2.184
Submission category :
Year :
2002
Submission ID :
2180
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Bradley K. Evans, Robert P. Kustra, Anne E. Hammer, John A. Messenheimer. Neurology Clinic, Northern Michigan Neurology, Traverse City, MI; Epilepsy Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC
RATIONALE: Lamotrigine has been studied in clinical trials at tertiary settings enrolling highly selected patients. The utility of LTG in a broadly based neurology practice setting may be different.
This study evaluated the efficacy of lamotrigine (LTG) as adjunctive therapy in a community-based, observational setting.
METHODS: Patients with partial epilepsy age 16 years and older entered the study either because of poor seizure control or unacceptable side effects on their current antiepileptic drug (AED) therapy. Open-label LTG (LAMICTAL[reg]) was titrated according to labeling to a target dose of 300-500mg/day (100-400 mg/day for patients on an AED regimen containing valproate), based on individualized adjustment. Seizure control was assessed using patient diaries during the last eight weeks of the 16-week adjunctive phase. Investigators also assessed overall clinical status.
RESULTS: 547 patients were enrolled (mean age 42.7 years, 58% female, median baseline seizure frequency 2/month). Of these 547, 421 patients (77%) completed the adjunctive phase. Average daily maintenance dose of LTG was 300mg in patients taking enzyme-inducing AEDs (e.g. phenytoin, carbamezepine) and 200mg in patients taking an AED regimen containing valproate, an enzyme inhibitor. During the last eight weeks of adjunctive therapy, average seizure counts decreased 34% from baseline (p[lt]0.01). There was a 70% responder rate ([gt]= 50% reduction in seizures) and 43% were seizure-free. Investigators overall assessment noted improvement in 71% of patients. Two patients had worsening of seizures as serious adverse events leading to withdrawal. Sixty (11%) patients discontinued due to lamotrigine adverse events and two patients (0.4%) discontinued due to serious allergic reactions (hypersensitivity syndrome).
CONCLUSIONS: In the community neurology setting, addition of LTG to other AEDs produces substantial reductions in seizures.
[Supported by: GlaxoSmithKline Research and Development]; (Disclosure: Grant - Received grant to conduct study described in abstract.)