Clinical Neuroscience

[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 Péter, SZÍJÁRTÓ Elvira

SEPTEMBER 30, 2006

Clinical Neuroscience - 2006;59(09-10)

[Purpose - To evaluate the efficacy and safety of gabapentin (GBP) in idiopathic or crypto/symptomatic partial epilepsy in adults. Methods - 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 quailty 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. Population - 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. Results - 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. Consequences - 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.]

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[Mortality in epilepsy is 2-3 times higher than in the age- and sex-matched general population. It is the highest in young male epilepsy patients with generalised tonic-clonic seizures living in low socio-economical situation. The main factors of early mortality unrelated to seizures are the neurological conditions underlying epilepsy. Suicide is an important factor first of all in temporal lobe epilepsy. The group of mortality directly related to epilepsy is made up of the high-mortality grand mal status epilepticus rarely seen in treated epilepsy; the accidents related to seizures and sudden unexpected death (SUDEP). The reasons directly related to epilepsy make up about 40 per cent of epilepsy mortality. There is a 20-24-fold increase of the risk of sudden death in epilepsy compared to sudden death in the general population. The main risk of SUDEP is the “severity” of epilepsy signaled by generalized tonic-clonic seizures, resistance to antiepileptic drugs, polytherapy and frequent drug-modifications in adulthood epilepsy. Seizure-dependent autonomic changes as cardiac rhythm and breathing disturbances as well as some antiepileptic drugs and treatment modifications may contribute to the development of SUDEP. The data suggest that the main tools helping to decrease mortality in epilepsy nowadays are as follows: optimal seizure control, effective tratment of concomitant psychiatric conditions and monitoring for potentially dangerous heart dysrhythmias as well as respiration disorders.]

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