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NEUROLOGY

Topiramate Titration to Response: Analysis of Individualized Therapy Study (TRAITS)

Professor of Pediatrics and Neurology, Department of Pediatric Neurology, School of Medicine, Washington University, St. Louis, MO

Marc Kamin, MD

Executive Director, Clinical Investigations, Clinical Affairs, Ortho-McNeil Pharmaceutical, Raritan, NJ

Lesley Kraut, MBA

Assistant Director, CNS Projects, Clinical Affairs, Ortho-McNeil Pharmaceutical

William H Olson, PhD

Senior Director, Quantitative Methodology, Ortho-McNeil Pharmaceutical

Shu-Chen Wu, PhD

Assistant Director, Quantitative Methodology, Ortho-McNeil Pharmaceutical

Reprints: W Edwin Dodson MD, Department of Pediatric Neurology, School of Medicine, Washington University, 660 S. Euclid Ave., Suite 100, St. Louis, MO 63110-1093, FAX 314/362-4658, E-mail edodson{at}msnotes.wustl.edu

OBJECTIVE: To evaluate the relationship between baseline seizure frequency and stabilized topiramate dosage and the effect of individualized treatment on tolerability in adults with partial-onset seizures receiving other antiepileptic drugs (AEDs).

METHODS: In this 20-week, open-label trial, dosages of medications were adjusted according to clinical response. Dosage and seizure response data were analyzed for 2 groups defined by baseline seizure frequency: <4 and 4 seizures per month.

RESULTS: In the outcome evaluable population (n = 471), the mean ± SEM stable topiramate dosage was 303 ± 139 mg/d when baseline seizure frequency was <4 seizures/month and 341 ± 153 mg/d when baseline seizure frequency was 4 seizures/month (p = 0.005). The most common adverse events were somnolence (8.5%), fatigue (7.3%), nausea (5.3%), and dizziness (5.0%). Cognitive complaints were reported by <3% of patients. When concomitant AED dosages were reduced, 14% of patients discontinued topiramate due to adverse events compared with 23% if the concomitant AED dosage was unchanged or increased.

CONCLUSIONS: When clinicians individualize topiramate dosage according to clinical response, the stabilized topiramate dosage as add-on therapy is influenced by baseline seizure frequency. Topiramate tolerability is improved when dosages of concomitant AEDs are reduced.

Key Words: prognostic factors, tolerability, topiramate

Published Online, March 26, 2003. www.theannals.com, DOI 10.1345/aph.1C133

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