Broad Spectrum Activity of Lamotrigine Monotherapy in Patients with Juvenile Myoclonic Epilepsy
Abstract number :
2.005
Submission category :
Year :
2000
Submission ID :
500
Source :
www.aesnet.org
Presentation date :
12/2/2000 12:00:00 AM
Published date :
Dec 1, 2000, 06:00 AM
Authors :
George L Morris, James Schimschock, Alain Vuong, Anne E Hammer, Pamela S Barrett, Medical Coll of Wisconsin, Milwaukee, WI; Emanuel Medical Bldg, Portland, OR; Glaxo Wellcome Inc, RTP, NC.
RATIONALE: Valproate (VPA), an antiepileptic drug (AED) used for the treatment of JME, has been associated with significant side effects that may be unacceptable to many patients. Lamotrigine (LAMICTAL?, LTG) is indicated for treatment of generalized seizures (GS) of Lennox-Gastaut Syndrome, but data on its use in other generalized seizures types (e.g., JME) are limited. METHODS: Patients with JME were ?12 yrs old. Group 1 patients were receiving VPA and experiencing inadequate seizure control or unacceptable side effects. Group 2 consisted of new onset JME patients who received no treatment or were receiving inappropriate treatment with 1 AED (e.g., due to initial misdiagnosis). LTG dosing was escalated over 8 weeks while the concurrent AED (if any) was tapered, then LTG monotherapy was maintained for 24 weeks at 100-500 mg/day based on clinical response. The primary endpoint is reduction in GS (absence and generalized tonic/clonic seizures) and number of days with myoclonus. RESULTS: Group 1, VPA treated patients: 63 patients, 73% female, mean age 29 yrs, 17% with inadequate seizure control and 83% with unacceptable side effects. Mean LTG dose was 314 mg/day. During the last 8 weeks of maintenance 83% became seizure-free and 70% had no myoclonus. Compared to a 3-month historical baseline, 87% experienced a ?75% decrease in GS and 80% had a ?75% decrease in days with myoclonus. 63% of patients rated their satisfaction with LTG monotherapy compared to valproate as "much better" . Group 2, new onset JME: 29 patients, 59% female, mean age 24 yrs, 48% with no concurrent AED at study entry, 17% carbamazepine, 21% phenytoin. Mean LTG dose was 318 mg/day. During the last 8 weeks of maintenance 75% became seizure-free and had no myoclonus. Compared to a 3-month historical baseline, 80% experienced a ?75% decrease in GS and 95% had a ?75% decrease in days with myoclonus. Most patients rated their satisfaction with LTG as "highly" (70%) or "moderately" (20%) satisfied. CONCLUSIONS: LTG monotherapy was effective and well tolerated in both new-onset patients with JME and in patients with JME who had inadequate seizure control or unacceptable side effects with valproate.