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Lamotrigine in Multihandicapped Therapy-Resistant Epileptic Patients

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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.

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Authors and Affiliations

  1. Bethel Epilepsy Centre, Teilanstalt Bethel, Maraweg 9, 33617, Bielefeld, Germany

    Bernd Huber & M. Seidel

  2. Bethel Epilepsy Centre, Gesellschaft für Epilepsieforschung, Bielefeld, Germany

    Th. May

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  1. Bernd Huber
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  2. Th. May
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  3. M. Seidel
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Huber, B., May, T. & Seidel, M. Lamotrigine in Multihandicapped Therapy-Resistant Epileptic Patients. Clin. Drug Investig. 16, 263–277 (1998). https://doi.org/10.2165/00044011-199816040-00001

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  • DOI: https://doi.org/10.2165/00044011-199816040-00001

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