LONG TERM EFFICACY AND TOLERABILITY OF LEVETIRACETAM (LEV) IN 103 PATIENTS WITH PARTIAL AND GENERALIZED EPILEPSY
Abstract number :
2.206
Submission category :
Year :
2002
Submission ID :
93
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Vicenta Salanova, Marsha Manley. Neurology, Indiana University, Indianapolis, IN; Neurology, Indiana University, Indianapolis, IN
Objective: To analyze the efficacy and tolerability of LEV in a large group of unselected patients with different seizure types, and to determine whether monotherapy and slower titration improves tolerability.
Rationale: Levetiracetam is approved as adjuntive therapy for partial seizures, however, animal studies suggest that LEV may also be effective in generalized seizures. Some human studies found that LEV may be effective in generalized epilepsy , but others were inconclusive. LEV is well tolerated , however, in some patients somnolence in the first four weeks of treatment may lead to reduction or discontinuation of LEV. We report 103 patients with partial and generalized epilepsy treated with LEV using slow titration, and follow closely for almost two years, to determine long term efficacy and tolerability.
METHODS: One hundred-three patients with refractory epilepsy treated with LEV. The patients were not selected based on seizure type. The age at seizure onset ranged from 1 year to 35 years, and the age at the time of treatment with LEV ranged from 9 yrs to 53 yrs. 92/103 (89%) had partial seizures and 11/103 ( 11%) had generalized seizures. All patients have been tried on at least two or three AED (Antiepileptic drugs). In most patients LEV was added starting with 250 mg BID and increased by 250 mg every one or two weeks. In two patients with epilepsia partialis continua LEV was titrated faster in the epilepsy monitoring unit. The average dose was 2000 mg / day and the maximun dose was 4000 mg/ day. Seven patients were converted to monotherapy and several others are currently being converted. Patients were followed in the clinic at 3 mths and 6 months interval, (longest follow-up almost two years) and response and side effects were recorded.
RESULTS: The responder rate (more than 50% seizure reduction) for the 103 patients was 47%. As many as 17% (18/103) of these patients became seizure free ( longest follow-up almost two years). 9.7% 10/103) of the patients discontinued LEV due to lack of efficacy or poor tolerability; however, only 3.8% ( 4/103) of the patients discontinued LEV due to significant behavioral disturbances (aggression, depression, hostility). In the remaining patients LEV was well tolerated including several patients who had continued to have seizures following epilepsy surgery and became seizure free when LEV was added; some patients remained seizure free even when converted to monotherapy. LEV was also particularly helpful in those patients with refractory epilepsy due to brain tumors because of the lack of pharmacokinetic interactions with chemotherapy agents.
CONCLUSIONS: Levetiracetam ( LEV) demonstrated a broad spectrum of action in both children and adults with partial and generalized epilepsy. Our study showed that LEV can be effective as monotherapy, and that slow titration improves tolerability.