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Long-term efficacy and tolerability of topiramate as add-on therapy in refractory partial epilepsy: An observational study
Article first published online: 26 JUN 2009
DOI: 10.1111/j.1528-1167.2009.02177.x
Wiley Periodicals, Inc. © 2009 International League Against Epilepsy
Additional Information
How to Cite
Cho, Y.-J., Heo, K., Kim, W.-J., Jang, S. H., Jung, Y. H., Ye, B. S., Song, D. B. and In Lee, B. (2009), Long-term efficacy and tolerability of topiramate as add-on therapy in refractory partial epilepsy: An observational study. Epilepsia, 50: 1910–1919. doi: 10.1111/j.1528-1167.2009.02177.x
Publication History
- Issue published online: 29 JUL 2009
- Article first published online: 26 JUN 2009
- Accepted April 17, 2009; Early View publication June 26, 2009.
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Keywords:
- Epilepsy;
- Refractory;
- Topiramate;
- Efficacy;
- Tolerability
Summary
Purpose: To evaluate the long-term efficacy and tolerability of topiramate (TPM) as add-on therapy in patients with refractory partial epilepsy.
Methods: This is a retrospective, single-center, long-term observational study. Patients fulfilling the criteria of medical intractability proposed by Berg et al. were entered into the study if they were newly prescribed TPM as add-on therapy between January 2000 and June 2002. The usual starting dosage of TPM was 50 mg/day and optimal-dose adjustments were made according to individual clinical responses. Efficacy and tolerability were analyzed every year during 5-year follow-up in the “intention-to-treat (ITT) population.” Retention rate was estimated by Kaplan-Meyer analysis.
Results: A total of 125 patients were included in the study and 107 patients (85.6%) were followed for 5 years. Retention rate was 87.2% at 1 year and 64% at 5 years. At the end of 5 years, the median seizure frequency reduction rate was 69.0% and responder rate was 43.2% in the ITT population. Cumulative seizure-free rate (SFR) was 30.4% and the terminal 1-year SFR was 12.8% in the ITT population (20.0% in completers) at 5-year follow-up. Adverse events (AEs) occurred in 39.2% of patients, including significant AEs leading to antiepileptic drug (AED) withdrawal in 14.4%. The most common AEs were anorexia (16.0%), weight loss (10.4%), and gastrointestinal symptoms (8.8%). Concomitant AEDs were reduced in 25.0% of the completers.
Discussion: Low-dose and slow-dose escalation of TPM in add-on therapy for patients with refractory partial epilepsy is effective and well tolerated in long-term, individualized clinical practice.