EVALUATION OF SEIZURE COTROL, ADVERSE EVENTS AND QUALITY OF LIFE IN PATIENTS CONVERTING TO LAMOTRIGINE MONOTHERAPY
Abstract number :
2.194
Submission category :
Year :
2002
Submission ID :
2576
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Lisa M. Leschek-Gelman, Dawn A. Groenke, Anne E. Hammer, John A. Messenheimer. Neurology Clinic, Neurology Associates, Wilmington, DE; Epilepsy Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC
RATIONALE: The goals of successful AED therapy are no seizures and no side effects. Therefore, patients with epilepsy who experience inadequate seizure control and/or intolerable side effects may want to change AED therapy. This study examined the changes in seizure control and quality of life after converting from enzyme-inducing AED (e.g. carbamazepine, phenytoin) to lamotrigine (LTG) monotherapy.
METHODS: In an open-label trial, epilepsy patients ) [gte]16 years of age with partial onset seizures who wanted to change their AED due to inadequate seizure control and /or unacceptable side effects were enrolled. Patients must have had partial seizures with or without additional seizure types. After completing a 16-week LTG (LAMICTAL[reg]) adjunctive therapy phase, eligible patients on a single enzyme-inducing AED began a 12-week monotherapy phase. Patients[ssquote] seizure rates and scores on the Liverpool Adverse Event Profile (AEP), POMS, and QOLIE-31 questionnaire at end of LTG monotherapy were compared to baseline (screening visit).
RESULTS: Of 178 patients who started the LTG monotherapy phase, a total of 143 patients (80%) completed the monotherapy phase. Median dose of LTG was 400mg/day at the end of monotherapy phase. Compared to baseline, mean seizure frequency (3.9/mo vs 1.8/mo) and seizure free rates (24% vs 51%) improved. After LTG monotherapy, improvement in patients[ssquote] scores on the AEP were also noted (baseline score=41.2, monotherapy score=35.2). Total mood disturbance measured by the POMS improved during monotherapy (56.5 vs 31.0). Patients also reported improvements in all seven QOLIE-31 subscales at the end of LTG monotherapy with the mean change from baseline in the Overall Score of 14.6. At the end of monotherapy 85% reported moderate or high satisfaction with LTG monotherapy compared to 25% before switching to LTG.
CONCLUSIONS: Patients converting to LTG monotherapy from a single enzyme inducing AED for either seizure-control or tolerability issues, experienced improvement their in seizure control, adverse event profile, and quality of life as measured by the QOLIE-31.
[Supported by: GlaxoSmithKline Research and Development]; (Disclosure: Salary - Coauthors are employees of GlaxoSmithKline, Grant - Leschek-Gelmen received a grant from GlaxoSmithKline for conduct of the study, Honoraria - Lescheek-Gelman receivined funding from GlaxoSmithKline and Pfizer)