Postmarketing experience with topiramate and cognition

Ideal antiepileptic drugs (AEDs) are designed to stop seizures with limited central nervous system (CNS) side effects. However, CNS-related treatment- emergent adverse events (TEA-Es) often occur in patients receiving AEDs. To piramate (TPM) is an AED proven to be safe and effective as adjunctive trea tment for epilepsy patients with partial seizures. Double-blind, placebo-co ntrolled, multicenter trials demonstrated potential effects on cognition. T he P.A.D.S. (postmarketing antiepileptic drug survey) group, a cooperative group of 14 epilepsy centers that collaborate on obtaining data about new A EDs and devices, prospectively collected standardized data forms before and during treatment with TPM for epilepsy, and analyzed the postmarketing exp erience of CNS TEAEs with TPM. Our results from 701 treated patients show t hat cognitive complaints were the most common reason to discontinue TPM. Th e presence of complaints did have predictive value if the patient would dis continue TPM, although was not specific as to when discontinuation would oc cur. The spectrum of complaints in our open-label prospective multicenter p ostmarketing study was similar to those observed in controlled clinical tri als. We were unable to demonstrate a specific population, dose titration, o r concomitant AED that was at risk to discontinue treatment. We conclude that most patients treated with TPM will continue therapy beyon d 6 months. Cognitive complaints and not efficacy reflect the primary reaso n for discontinuing therapy. Psychomotor slowing was the most common compla int, yet most patients elect to continue treatment, with "better" or "much better" ratings of both seizure and global improvement during treatment.