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Postmarketing experience with topiramate and cognition
W O Tatum1, J A French, E Faught
1Department of Neurology, Tampa General Hospital, University of South Florida, Tampa, Florida, USA. WOTIV@aol.com
Epilepsia
|October 3, 2001
Summary
Cognitive complaints, particularly psychomotor slowing, are the primary reason for discontinuing topiramate (TPM), an antiepileptic drug. However, most patients continue TPM therapy long-term, reporting seizure and global improvement.
Area of Science:
- Neurology
- Pharmacology
- Clinical Trials
Background:
- Antiepileptic drugs (AEDs) aim to control seizures with minimal central nervous system (CNS) side effects.
- CNS-related treatment-emergent adverse events (TEAEs) are common with AEDs.
- Topiramate (TPM) is an effective adjunctive treatment for epilepsy, but CNS effects, including cognitive, have been noted.
Purpose of the Study:
- To analyze the postmarketing experience of CNS TEAEs with TPM in epilepsy patients.
- To identify the primary reasons for discontinuing TPM therapy.
- To assess the predictive value of cognitive complaints on treatment discontinuation.
Main Methods:
- Prospective, open-label, multicenter postmarketing study involving 701 epilepsy patients treated with TPM.
- Standardized data collection before and during TPM treatment.
- Analysis of CNS TEAEs and reasons for treatment discontinuation.
Main Results:
- Cognitive complaints were the most frequent reason for discontinuing TPM.
- Psychomotor slowing was the most common cognitive complaint.
- Despite complaints, most patients continued TPM beyond 6 months, reporting seizure and global improvement.
Conclusions:
- Cognitive complaints, not efficacy, are the main driver for discontinuing TPM.
- Most patients tolerate TPM well long-term, experiencing seizure control.
- The spectrum of CNS complaints observed is consistent with findings from controlled clinical trials.