Abstract
The efficacy and safety of lamotrigine as add-on therapy in treatment-resistant epilepsy were evaluated in an open prospective study carried out at five centres in Portugal and involving 61 patients. Daily seizure diaries were kept by patients, and used by the investigators to give a rating of response to therapy. Assessments were recorded after 1, 2, 3, 6, 9, 12, 18 and 24 months. Overall, seizure control was improved in 57% of patients, remained unchanged in 34% and deteriorated in 9%. There were some indications that efficacy was greatest in patients with generalized seizures and in those taking concomitant valproate. Efficacy was maintained throughout the 2-year study. It was possible to reduce the dose of concomitant antiepileptic drug in 56% of patients, and seven patients no longer needed a concomitant antiepileptic drug. Although 75% of patients reported an adverse experience, most of these were mild or moderate in intensity, did not require treatment and were not judged to be serious. A total of 13 patients withdrew from the study (four due to adverse events, four due to lack of efficacy and five for other reasons).