Abstract
Our aim was to investigate the long-term efficacy and side effect profiles of levetiracetam (LEV) in patients with difficult to treat partial and generalized epilepsies in an open labeled, multicentral study. A total of 397 patients with a seizure history from 1–80 years (average 21 years) were systematically investigated by a standardized questionnaire. Parameters concerning the seizure frequency and side effects 6 months before and 6 months during LEV treatment were investigated. The average daily dosage of LEV was 2130 mg (range 500–6000 mg). 366 patients (186 males and 180 females) aged from 4 to 88 years (average 34 y) finished the investigation. 83.2% of them had focal and 16.8% with generalized or non-localized epilepsies. The mean number of antiepileptic drugs before LEV was 4.6. The duration of LEV treatment ranged from 6 to 34 months with an average of 17.8 months. In more than 95% of cases, LEV was used as add-on therapy to carbamazepine or lamotrigine and/or valproate acid. A complete seizure control was obtained in 16.3%, a more than 75% seizure reduction was achieved in 9.5% patients and 16.9% patients had a 50% seizure reduction. The dropout rate was 9.3%, mostly (78%) because of the side effects and 22% because of the insufficient seizure control. The most common side effect was tiredness (8.8%) and followed by aggressiveness (5.7%). In a small portion of the patients (9%), seizure recurred despite increment of the dosage after the 6-month treatment. LEV is effective and safe in patients with difficult to treat epilepsies. Emotional instability is the most prominent central nervous side effect.
Zusammenfassung
Die antikonvulsive Wirkung von Levetiracetam wurde im Tierversuch und in plazebokontrollierten Studien vor der Zulassung untersucht [1–3]. Kontrollierte Monotherapiestudien werden gegenwärtig durchgeführt. Im Folgenden wird über eine offene Studie zur Langzeitwirksamkeit und zum Nebenwirkungsprofil bei 397 Patienten (Durchschnittsalter 21 Jahre) mit schwer behandelbarer fokaler und generalisierter Epilepsie berichtet. 83,2% der Patienten litten an fokalen, 16,8% an generalisierten oder nicht lokalisierten Epilepsien. Die durchschnittliche Anzahl von Antiepileptika vor LEV ist 4,6. Die Behandlungsdauer mit LEV lag zwischen 6 bis 34 Monaten, die durchschnittliche Dauer lag bei 17,8 Monaten. Eine vollständige Anfallskontrolle wurde bei 16,3%, eine 75%ige Anfallsreduzierung bei 9,5% der Patienten erzielt und 16,9% der Patienten erfuhren eine 50%ige Anfallsreduktion. Die Dropout-Rate lag bei 9,3%, dies hauptsächlich (78%) wegen der Nebenwirkungen und wegen (22%) der ungenügenden Anfallskontrolle. Die am häufigsten aufgetretenen Nebenwirkungen waren Müdigkeit (8,8%) gefolgt von Aggressivität (5,7%).
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Stefan, H., Wang-Tilz, Y., Feichtinger, M. et al. Wirkungen und Nebenwirkungen von Levetiracetam bei schwer behandelbaren Epilepsien. Z. Epileptol. 19, 24–27 (2006). https://doi.org/10.1007/s10309-006-0184-2
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DOI: https://doi.org/10.1007/s10309-006-0184-2