Efficacy, safety and effect on the quality of life of gabapentin in adult epilepsy--results of a prospective open-label quasi naturalistic Hungarian multicenter study (phase human-IV)
Rajna, P.ét.; Szíjártó, E.
Ideggyogyaszati Szemle 59(9-10): 361-372
2006
ISSN/ISBN: 0019-1442 PMID: 17165379 Document Number: 597018
To evaluate the efficacy and safety of gabapentin (GBP) in idiopathic or crypto/symptomatic partial epilepsy in adults. We performed a prospective open label add-on study in pharmacoresistant patients with simple or complex partial or generalized seizures of partial onset (at least four seizures per month). GBP was added to no more than two baseline antiepileptics and the efficacy was rated primarily according to the seizure frequency. The secondary efficacy parameters were the change in the seizure severity scores (measured by the NHS3 scale) and in the quality of life (measured by the QUOLIE-31 questionnaire). GBP was added up to 1500-1600 mg per day in the titration period than an individual optimalization was allowed in any further visits. The follow-up period was three months. Fourteen Hungarian epilepsy out-patient unit participated in the study. 72 patients were enrolled, GBP was applied in 63 persons (ITT population) and 57 completed the study. A more than 50% decrease in seizure frequency was found in more than 70% of the patients in the third month. Among them just every third patient became seizure-free. Significant improvement appeared also in the severity of seizures and in the total score of the quality of life questionnaire. There was no difference either according to the etiology of the epilepsy or the seizure types. GBP was tolerated excellently. There was no need to decrease of the dosage of GBP and the side effects were mild and of transitory nature. GBP appears to be a valuable antiepileptic drug considering its high efficacy and extremely favourable tolerance. While GBP also decreases the severity of the seizures, its complex effects result an improvement in the quality of life of the patients. The positive effects have been durable during the follow-up. Open label naturalistic studies of larger population are needed to clear the special indications of GBP in chronic partial epilepsies.