one-year observation of topiramate in add

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Epileptologia 2004, 12: 55-64
ONE-YEAR OBSERVATION OF TOPIRAMATE IN ADD-ON THERAPY
IN PATIENTS WITH DRUG RESISTANT EPILEPSY
Joanna Jędrzejczak 1, Krzysztof Owczarek 1, 3 Ałbena Grabowska-Grzyb 1,
Piotr Zwoliński 1,2, Jerzy Majkowski3
Department of Neurology and Epileptology
Medical Centre for Postgraduate Education
231 Czerniakowska Str., 00-416 Warszawa
1
Department of Neurosurgery
“Child Health Memorial Centre” Institute
Al. Dzieci Polskich 20, 04-726 Warszawa
2
3
Didactic Center in Epileptology and Other Paroxysmal Events
Foundation of Epileptology
122 Wiertnicza Str., 02-952 Warszawa
Summary
Introduction. Topiramate (Topamax, TPM) is an effective AED, used to treat partial-simple, partialcomplex and secondarily generalised to tonic-clonic seizures. The drug’s pharmakokinetic profile and
the outcomes of clinical trials suggest that TPM may be used in both polytherapy and monotherapy.
Objective. The aim of the study was to conduct a one-year observation of the effectiveness and
safety of topiramate in patients with drug-resistant epilepsy in the form of partial seizures with or
without secondary generalisation.
Material and method. Eighty-six patients (36 F and 50 M) were studied. The mean age of the patients was 30 years (13-61) and the mean duration of epilepsy was 19 years (2-55). Thirty-seven
(41.2%) of the total number of 86 patients with partial seizures had secondarily-generalised seizures, 8 (8.9%) had secondary generalised to tonic-clonic seizures and 41 (45.5%) had both types of
seizures. The drug was administrated twice a day, mean daily dose was 5,2mg/kg (0.8-11.7/kg). The
patients were observed for 12 months. The results were submitted to statistical analysis using the
Student T test.
Results. In the group of 86 patients with one year add-on therapy with TPM, reduction of seizures by
at least 50% was observed in 47 patients (54,7%), in which group 100% reduction was obtained in 14
patients (16,3 %), and seizure reduction higher than 50% was observed in 33 patients (38,4%).
Reduction of seizures by less than 50% was observed in 39 (45,3%) patients. The figures were stable
throughout the entire term of observation. Side effects were registered and treatment was discontinued in 20% of patients. Our clinical experience to date suggests that tolerance to TPM does not
develop despite prolonged treatment with the drug. Only a small percentage of patients had to
discontinue treatment due to clinical deterioration in the form of increased frequency of seizures.
K ey words: Epilepsy – Topiramate – Treatment – Effectiveness of long-term antiepileptic treatment
– Adverse events
Recived September 27, 2003