EVALUATION OF LAMOTRIGINE AS ADJUNCTIVE AND MONOTHERAPY IN ELDERLY PATIENTS WITH EPILEPSY: A SUB-ANALYSIS OF A LARGE OBSERVATIONAL STUDY
Abstract number :
2.192
Submission category :
Year :
2002
Submission ID :
3229
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Robert P. Kustra, Anne E. Hammer, John A. Messenheimer. Epilepsy Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC
RATIONALE: With the increasing age of the general population, the number of elderly patients with epilepsy is also increasing. Management of epilepsy in this population presents unique pharmacodynamic and pharmacokinetic challenges.
This study examined the effectiveness and tolerability of lamotrigine (LTG) as adjunctive and monotherapy treatment in the subset of patients 60 years of age and older participating in a large, community based observational study.
METHODS: In an open label trial patients with epilepsy [gte] 16 years of age with partial onset seizures who wanted to change their antiepileptic drug (AED) due to inadequate seizure control and/or unacceptable side effects were enrolled. 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. After completing a 16-week LTG adjunctive therapy phase, eligible patients who took a single enzyme-inducing AED (e.g. carbamazepine or phenytoin) began a 12-week monotherapy phase. Multiple assessments of tolerability and effectiveness were made (see table).
RESULTS: Sixty-two of the 547 patients in the trial were greater than 60 years of age, (range 60-93). Of these 62 patients, 46 (74%) and 21(39%) completed the adjunctive and monotherapy phases, respectively. Improvements were seen in all of the following assessments:[table1]Efficacy and tolerability results from this elderly population were similar to the non-elderly patients in the overall study population.
CONCLUSIONS: In this elderly population, lamotrigine was well tolerated and effective as both adjunctive and monotherapy treatment and resulted in improved patient satisfaction and quality of life.
[Supported by: GlaxoSmithKline Research and Development]; (Disclosure: Salary - Employee of GlaxoSmithKline)