LAMOTRIGINE AS ADJUNCTIVE THERAPY IMPROVES TOLERABILITY, PATIENT SATISFACTION AND QUALITY OF LIFE IN A COMMUNITY NEUROLOGY SETTING
Abstract number :
2.202
Submission category :
Year :
2002
Submission ID :
459
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Marshall Nash, Robert Kustra, Anne Hammer, John Messenheimer. Neurology Clinic, Dekalb Neurology Associates, LLC, Decatur, GA; Epilepsy Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC
RATIONALE: Lamotrigine (LTG) has been studied in clinical trials at tertiary settings enrolling highly selected patients. The utility of LTG in a broader-based neurology practice setting may be different.
This observational study evaluated the tolerability and effects on quality of life of lamotrigine as adjunctive therapy in a community-based 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 an adjunctive therapy target dose of 300-500mg/day (100-400 mg/day for patients on an AED regimen containing valproate), based on individualized adjustment. Investigators completed subjective assessments in seven domains and a global assessment, and patients completed the QOLIE-31 (quality of life inventory); the POMS mood profile; a self-rated measure of satisfaction; and the Liverpool Adverse Event Profile (AEP), a measure of anticonvulsant tolerability.
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. Concomitant AEDs were primarily carbamazepine (38%), phenytoin (35%) and valproate (25%). After 16 weeks of adjunctive therapy:
[bullet] Investigator assessment improved in every tested category (p[lt]0.01)
[bullet] Self-scored patient satisfaction improved (p[lt]0.01)
[bullet] The POMS mood instrument showed improvements on every subscale (p[lt]0.01)
[bullet] The AEP survey on showed improvement in every subscale (p[lt]0.05) except disturbed sleep
[bullet] Quality of life improved on every subscale of the QOLIE-31 and overall (p[lt]0.01)
Sixty (11%) patients discontinued due to lamotrigine-related adverse events and there were two (0.4%) serious allergic reactions (hypersensitivity syndrome) reported.
CONCLUSIONS: In the community neurology setting, the addition of LTG to other commonly used AEDs produces substantial improvement in global investigator assessments, mood, medication tolerability, and quality of life.
[Supported by: GlaxoSmithKline Research and Development]