LAMOTRIGINE ADJUNCTIVE AND MONOTHERAPY IMPROVES MOOD IN PATIENTS WITH EPILEPSY
Abstract number :
2.278
Submission category :
Year :
2003
Submission ID :
2538
Source :
www.aesnet.org
Presentation date :
12/6/2003 12:00:00 AM
Published date :
Dec 1, 2003, 06:00 AM
Authors :
J. Chris Sackellares, Robert P. Kustra, Anne E. Hammer Department of Neurology, University of Florida, Gainsville, FL; Epilepsy Clinical Development and Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC; Biomedical Data Sciences, GlaxoSmithKlin
Lamotrigine(LTG) has been shown effective in treating the depressive phase of bipolar disorder in randomized clinical trials. Additional studies have shown positive mood effects of LTG in patients with epilepsy. This study evaluated the effect of LTG as adjunctive therapy and monotherapy on mood in patients with epilepsy.
Data for this analysis were collected as part of a large outpatient study. 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 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. Mood was assessed with the profile of mood states (POMS) at baseline and at the end of both the adjunctive and monotherapy phases. POMS total mood disturbance scores range from [ndash]32 to 200 with higher scores indicating greater mood disturbance.
196 patients enrolled (mean age 43 years, 58% female, median baseline seizure frequency 2/month). At baseline, the majority of patients were taking older AEDs, primarily carbamazepine, phenytoin, and valproate. Of the 196 patients, 152 (78%) completed the adjunctive phase. Sixty-eight patients attempted conversion to monotherapy and 56 (82%) completed the monotherapy phase. Table 1 summarizes observed mood scores by study phase. [table1]Along with the improvement in total mood disturbance, improvements were noted across all subcales of the POMS, including anxiety, depression, anger, vigor, fatigue, and confusion.
Addition of LTG to the regimen of patients needing a change in AED therapy produced improvements in mood as measured by the POMS. Further improvements in mood were noted after conversion to LTG monotherapy.
[Supported by: GlaxoSmithKline Research and Development]