Evaluation of Seizure Control, Adverse Events, and Quality of Life in Patients Converting to LTG Monotherapy: An Interim Analysis
Abstract number :
2.242
Submission category :
Year :
2001
Submission ID :
2818
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
B.K. Evans, MD, Northern Michigan Neurology, Traverse City, MI; K.P. Nanry, GlaxoSmithKline, Research Triangle Park, NC; P.S. Barrett, PharmD, GlaxoSmithKline, Research Triangle Park, NC; W.J. Kwong, PharmD, GlaxoSmithKline, Research Triangle Park, NC; A.
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. The ideal therapy would be one that would improve seizure control and provides an improved quality of life. This study examined the changes in patients[scquote] seizure control, adverse event profile and quality of life after converting from another AED to lamotrigine (LTG, LAMICTAL[reg]) monotherapy.
METHODS: In an open label trial we enrolled epilepsy patients [gte]16 years of age with partial onset seizures who took an enzyme inducing AED and wanted to change their AED due to inadequate seizure control and/or side effects. Patients must have had partial seizures with or without additional seizure types. After completing a 16-week LTG adjunctive therapy phase, patients began a 12-week monotherapy phase. Patients[scquote] seizure rates and scores on the Liverpool Adverse Event Profile and QOLIE-31 questionnaire at baseline (screening visit) were compared to LTG monotherapy.
RESULTS: Ninety-one of the 119 patients who completed adjunctive therapy on a single enzyme inducing AED completed the LTG monotherapy phase. Compared to baseline, seizure free rates improved (23% vs 52%). Improvement in patients[scquote] scores on the Liverpool Adverse Event Profile were also noted (baseline score=21.0, monotherapy score=16.1). Patients also reported improvements in all seven QOLIE-31 subscales at the end of LTG monotherapy (mean changes from baseline were 15.6-Seizure Worry, 10.1-Overall Quality of Life, 10.0-Emotional Well-Being, 17.9-Energy/Fatigue, 16.1-Cognitive Functioning, 26.0-Medication Effects, 14.3-Social Functioning, 14.1-overall score).
CONCLUSIONS: Patients converting to LTG monotherapy from a single enzyme AED (e.g., carbamazepine or phenytoin) improved their seizure control and adverse event profile. Additionally, LTG robustly improved patients[scquote] quality of life as measured by the QOLIE-31.
Support: GlaxoSmithKline.
Disclosure: Salary - GlaxoSmithKline. Grant - GlaxoSmithKline. Equity - GlaxoSmithKline. Consulting - GlaxoSmithKline. Stock - GlaxoSmithKline.