OBJECTIVE: To analyze the overall therapeutic benefit (effect on seizures and quality of life) in 100 patients, aged 14-89 years, treated withlamotrigine (LTG) as primary (25) or secondary (75) monotherapy, followed up for between one and six years. PATIENTS AND METHODS: The patients were selected for treatment, under open observation, and not randomized at all. Thirty patients suffered from generalized seizures and 70 from partial crises, with progression to generalized tonic-clonic crises in 36 cases. The usual LTG serum level when bi-therapy was used was 2 to 4 mg and was similar with monotherapy. The predominant dosage of LTG (100 to 200 mg) was similar for monotherapy and for bi-therapy in those treated with valproate, as compared with 200-400 mg in most of those in whom the associated drug was carbamazepine (24), phenobarbital (14), phenytoin (6) or other drug, with a considerable reduction in dose (of 100 mg to 250 mg) when they were treated by monotherapy instead. RESULTS:Overall therapeutic benefit was obtained in 79 cases, partly due to suppression or reduction of the seisures, or maintenance free of them, but mainly due to correction of the side-effects, especially somnolence, attention disorders, obesity, tremor, ataxia, reduced global productivity, hyperlipidaemia and liver enzyme changes. CONCLUSION:Lamotrigine was more effective and better tolerated in smaller doses as monotherapy, and better than other drugs in reference to quality of life, especially by the supression of side-effects, demonstrating that it is valuable in obtaining overall improvement of the disease and its consequences.
RCT Entities:
OBJECTIVE: To analyze the overall therapeutic benefit (effect on seizures and quality of life) in 100 patients, aged 14-89 years, treated with lamotrigine (LTG) as primary (25) or secondary (75) monotherapy, followed up for between one and six years. PATIENTS AND METHODS: The patients were selected for treatment, under open observation, and not randomized at all. Thirty patients suffered from generalized seizures and 70 from partial crises, with progression to generalized tonic-clonic crises in 36 cases. The usual LTG serum level when bi-therapy was used was 2 to 4 mg and was similar with monotherapy. The predominant dosage of LTG (100 to 200 mg) was similar for monotherapy and for bi-therapy in those treated with valproate, as compared with 200-400 mg in most of those in whom the associated drug was carbamazepine (24), phenobarbital (14), phenytoin (6) or other drug, with a considerable reduction in dose (of 100 mg to 250 mg) when they were treated by monotherapy instead. RESULTS: Overall therapeutic benefit was obtained in 79 cases, partly due to suppression or reduction of the seisures, or maintenance free of them, but mainly due to correction of the side-effects, especially somnolence, attention disorders, obesity, tremor, ataxia, reduced global productivity, hyperlipidaemia and liver enzyme changes. CONCLUSION:Lamotrigine was more effective and better tolerated in smaller doses as monotherapy, and better than other drugs in reference to quality of life, especially by the supression of side-effects, demonstrating that it is valuable in obtaining overall improvement of the disease and its consequences.