Abstracts

REDUCTION OF ANTIEPILEPTIC DRUG ADVERSE EVENT BURDEN WITH ADJUNCTIVE AND MONOTHERAPY LAMOTRIGINE IMPROVES QUALITY OF LIFE IN PATIENTS WITH EPILEPSY

Abstract number : 1.285
Submission category :
Year : 2003
Submission ID : 3853
Source : www.aesnet.org
Presentation date : 12/6/2003 12:00:00 AM
Published date : Dec 1, 2003, 06:00 AM

Authors :
Robert P. Kustra, Anne E. Hammer, John A. Messenheimer Epilepsy Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC; Biomedical Data Sciences, GlaxoSmithKline, Research Triangle Park, NC

The goals of successful antiepileptic drug (AED) therapy are no seizures, no side effects, and normal quality of life. Recent studies indicate that a change to an AED with a lower adverse event burden may improve quality of life without sacrificing seizure control (Gilliam [italic]Neurology[/italic] 2002 58:S9-S20).
Data for this analysis were collected as part of a large outpatient study. Patients with epilepsy age 16 years and older enrolled due to poor seizure control or unacceptable side effects on their current AED therapy. Open-label lamotrigine (LTG, LAMICTAL[reg]) was titrated according to labeling to a target dose of 300-500mg/day (100-400mg/day for patients on an AED regimen containing valproate), based on individualized adjustment and maintained for sixteen weeks. Patients on a single enyzme-inducing AED were eligible to convert to LTG monotherapy for an additional twelve weeks. Scores on the Liverpool Adverse Event Profile (AEP) and Quality of Life in Epilepsy (QOLIE-31) questionnaires at end of LTG adjunctive and monotherapy were compared to baseline. The AEP is a 19-item assessment of AED adverse event burden with higher scores indicating greater burden; scores range from 19-76. The QOLIE is a 31-item assessment of overall quality of life with higher scores indicating better quality of life; scores range from 0-100. This analysis compared improvements in quality of life in patients with low adverse event burden ([lt] 45 on AEP, LO) versus high adverse event burden ([ge]45 on AEP, HI) at baseline. Seizure control was assessed by patient completed diaries.
Data from 538 patients were included. Demographics of the LO and HI groups were similar, except for percentage of women (51% of the LO group versus 66% of the HI group). Concurrent AED therapy was primarily carbamazepine, phenytoin and valproate and did not differ significantly between groups. Compared to the LO group, the HI group, experienced greater improvement in AEP scores at the end of both the adjunctive and monotherapy phases. [table1]In addition, the HI group experienced greater improvement in overall QOLIE-31 at the end of both the adjunctive and monotherapy phases compared to the LO group. [table2]Throughout the study, seizure control was similar in both groups.
In patients with epilepsy experiencing significant side effects while taking older AEDs, lamotrigine adjunctive therapy decreased adverse event burden and improved quality of life. Patients converting to lamotrigine monotherapy experienced further improvements.
[Supported by: GlaxoSmithKline Research and Development]