Efficacy and Tolerability of Topiramate in Patients with Epilepsy Previously Treated with Carbamazepine or Oxcarbazepine [ndash] Results of an Open-Label, Non-Interventional Study
Abstract number :
2.156
Submission category :
Antiepileptic Drugs-Adult
Year :
2006
Submission ID :
6595
Source :
www.aesnet.org
Presentation date :
12/1/2006 12:00:00 AM
Published date :
Nov 30, 2006, 06:00 AM
Authors :
1Andreas Schreiner, 2Joern-Roland Wettach, and 2Schauble Barbara
To evaluate seizure frequency and tolerability in patients with epilepsy treated with topiramate (TPM) transitioning from carbamazepine (CBZ) or oxcarbazepine (OXC)., Multicenter open-label non-interventional study. Patients [ge] 12 years of age with epilepsy previously unsuccessfully treated with CBZ (72,1%) or OXC (27,9%) were prospectively followed for 26 weeks after initiation and transition onto TPM. A 12 week retrospective seizure frequency was used as baseline., 140 patients (53,6% female; mean age 47,1 yrs (SD[underline]+[/underline]17,9)) were selected. Median duration of epilepsy was 9,5 years (range, 0-59 years). 84,3% had seizures during the 12 weeks retrospective baseline. Most frequent seizure types at baseline were generalized tonic-clonic (52%), complex partial (26%), and simple partial (16%). Main reasons provided for transitioning from CBZ/OXC onto topiramate were insufficient efficacy (75%) and/or side effects (80%). Side effects listed as reason for transitioning ([gt]10%) were fatigue (55%), dizziness (29%), headache (20%), weight increase (19%) or abnormal hepatic function (13%).
At endpoint, the median TPM dose was 100mg/day. Mean seizure frequency decreased from 6/month ([underline]+[/underline]SD 20,8) at baseline to 1,4 ([underline]+[/underline]SD 5,1)/month during the full observation period. The responder rate ([ge] 50 % seizure reduction) during the last 3 months of observation was 91%, and 62% of patients remained seizure-free during this period. 19% of patients discontinued TPM, in 12% due to an adverse event (AE), and 3% due to insufficient efficacy. The only treatment-emergent adverse events reported in [gt] 5 % were paraesthesia (9%) and weight decrease (8 %)., After transition from CBZ or OXC, topiramate was associated with a substantial reduction in seizure frequency, including a high seizure-free rate, and was well tolerated., (Supported by Janssen-Cilag Germany.)
Antiepileptic Drugs