B Huber1, T May, M Seidel. 1. Bethel Epilepsy Centre, Teilanstalt Bethel, Bielefeld, Germany.
Abstract
OBJECTIVES: This study evaluated the effects of lamotrigine in routine therapy in the highly selected clientele of the Residential Department of the Bethel Epilepsy Centre. PATIENTS AND METHODS: In an open, observational, add-on study design, 125 resident patients with severe therapy-resistant epilepsy and multiple additional handicaps were treated with lamotrigine in titrated doses. Seizure types, monthly seizure frequency, seizure severity, and psychological status were recorded during a 3-month baseline and a 3-month lamotrigine treatment period prior to the key date of this analysis (31 March 1996). RESULTS: At the time of analysis, the mean lamotrigine dosage was 391 mg/day (mean serum concentration 4.25 mg/L). 71.4% of the patients (after a mean observation time of 21.9 months) were still receiving lamotrigine. In the remaining 28.6%, the main reasons for withdrawal (after a mean of 10.5 months) were lack of effectiveness (19 patients, 15.2%), increase in seizure frequency (8 patients, 6.4%), and negative psychotropic effects (5 patients, 4.0%). On an intention-to-treat basis, the responder rate (reduction in seizure frequency by 50% or more) was 28.8% (35.6% in focal epilepsy, 26.7% in generalised epilepsy, and 22.4% in epilepsy with focal and generalised seizures). Seizure reduction was similar for all seizure types. Lamotrigine was more effective when combined with valproic acid (p < 0.005) and less effective when combined with carbamazepine or phenytoin. Stepwise multivariate logistic regression revealed valproic acid (and not lamotrigine dose or concentration, co-medication, epileptic syndrome, or seizure type) as the only factor predicting seizure response. 28.0% of the patients had shorter and/or less severe seizures, and 8.8% had longer/more severe seizures. 25.6% experienced a positive and 8.0% a negative psychotropic effect (mostly aggression). In all, 53.6% of patients benefited according to the three efficacy criteria, and 8.8% deteriorated. The most frequent dose-dependent adverse effects were ataxia, dizziness and diplopia. CONCLUSIONS: Lamotrigine was an effective and well tolerated drug for this special patient group, especially when combined with valproic acid.
OBJECTIVES: This study evaluated the effects of lamotrigine in routine therapy in the highly selected clientele of the Residential Department of the Bethel Epilepsy Centre. PATIENTS AND METHODS: In an open, observational, add-on study design, 125 resident patients with severe therapy-resistant epilepsy and multiple additional handicaps were treated with lamotrigine in titrated doses. Seizure types, monthly seizure frequency, seizure severity, and psychological status were recorded during a 3-month baseline and a 3-month lamotrigine treatment period prior to the key date of this analysis (31 March 1996). RESULTS: At the time of analysis, the mean lamotrigine dosage was 391 mg/day (mean serum concentration 4.25 mg/L). 71.4% of the patients (after a mean observation time of 21.9 months) were still receiving lamotrigine. In the remaining 28.6%, the main reasons for withdrawal (after a mean of 10.5 months) were lack of effectiveness (19 patients, 15.2%), increase in seizure frequency (8 patients, 6.4%), and negative psychotropic effects (5 patients, 4.0%). On an intention-to-treat basis, the responder rate (reduction in seizure frequency by 50% or more) was 28.8% (35.6% in focal epilepsy, 26.7% in generalised epilepsy, and 22.4% in epilepsy with focal and generalised seizures). Seizure reduction was similar for all seizure types. Lamotrigine was more effective when combined with valproic acid (p < 0.005) and less effective when combined with carbamazepine or phenytoin. Stepwise multivariate logistic regression revealed valproic acid (and not lamotrigine dose or concentration, co-medication, epileptic syndrome, or seizure type) as the only factor predicting seizure response. 28.0% of the patients had shorter and/or less severe seizures, and 8.8% had longer/more severe seizures. 25.6% experienced a positive and 8.0% a negative psychotropic effect (mostly aggression). In all, 53.6% of patients benefited according to the three efficacy criteria, and 8.8% deteriorated. The most frequent dose-dependent adverse effects were ataxia, dizziness and diplopia. CONCLUSIONS:Lamotrigine was an effective and well tolerated drug for this special patient group, especially when combined with valproic acid.
Authors: J Messenheimer; R E Ramsay; L J Willmore; R F Leroy; J J Zielinski; R Mattson; J M Pellock; A M Valakas; G Womble; M Risner Journal: Epilepsia Date: 1994 Jan-Feb Impact factor: 5.864