Tolerability and safety of topiramate in Chinese patients with epilepsy : an open-label, long-term, prospective study.

Abstract

OBJECTIVES:

This study focused on (i) evaluating the long-term tolerability and safety of topiramate in Chinese patients with epilepsy, and (ii) comparing the tolerability and safety of topiramate monotherapy versus polytherapy in the same population.

METHODS:

This was a prospective, open-label, long-term (36 months) clinical trial. 320 patients (275 adults and 45 children) with epilepsy were recruited into the study; of these, 156 patients had generalised seizures, 151 patients had partial seizures and 13 patients had unclassifiable seizures. All patients received topiramate approximately 200 mg/day either as monotherapy or as adjunctive therapy. At each visit, a physical examination and routine laboratory analysis were performed, and the adverse event (AE) profile was obtained by face-to-face interview.

RESULTS:

268 patients received topiramate <or=100 mg/day and 52 patients received topiramate 100-200 mg/day. Topiramate-associated AEs occurred in 98 patients (30.6%). The most common AEs were weight loss in 18 patients (8.4%), paraesthesias in 17 (7.2%), poor memory in ten (3.8%), and dizziness in six (2.8%). Most AEs were mild to moderate and transitory; discontinuation of topiramate was observed in 13 patients (4.1%) as a result of AEs such as impaired memory (seven patients [54%]), paraesthesias (four patients [31%]), and weight loss and cutaneous reaction (each one patient [7.5% each]). The rate of AEs was significantly higher with use of topiramate as monotherapy than as adjunctive therapy (68 patients vs 30 patients [47.8% vs 16.4%], respectively).

CONCLUSION:

Topiramate is well tolerated in Chinese patients with epilepsy in clinical practice. Compared with its use as adjunctive therapy, topiramate monotherapy is associated with a significantly higher frequency of adverse events.

• Authors: Yang Lu, Xuefeng Wang, Qihua Li, Jingmei Li, Yong Yan
• Journal: Clinical drug investigation (Clin Drug Investig) Vol. 27 Issue 10 Pg. 683-90 ( 2007) ISSN: 1173-2563 [Print] New Zealand
• PMID: 17803343 (Publication Type: Comparative Study, Controlled Clinical Trial, Journal Article)

Chemical References

• Anticonvulsants
• Topiramate
• Fructose

Topics

• Adolescent
• Adult
• Anticonvulsants (adverse effects, therapeutic use)
• Child
• China
• Dizziness (chemically induced)
• Drug Therapy, Combination
• Epilepsy (drug therapy)
• Female
• Fructose (adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Longitudinal Studies
• Male
• Memory Disorders (chemically induced)
• Paresthesia (chemically induced)
• Prospective Studies
• Topiramate
• Weight Loss (drug effects)