Efficacy of once-daily extended-release topiramate (USL255): A subgroup analysis based on the level of treatment resistance
2014
Abstract Results from a previously conducted global phase III study (PREVAIL; NCT01142193 ) demonstrate the safety and efficacy of once-daily USL255, Qudexy™ XR (topiramate) extended-release capsules, as adjunctive treatment of drug-resistant partial-onset seizures (POSs). In this study, we report a post hoc analysis of PREVAIL data according to patient level of treatment resistance (based upon the number of concomitant antiepileptic drugs [AEDs] and lifetime AEDs) at baseline, with patients defined as either having “highly” drug-resistant seizures (≥ 2 concurrent AEDs and ≥ 4 lifetime AEDs) or having “less” drug-resistant seizures (1 concurrent AED or P = .004 and P = .040 for “highly” and “less”, respectively). Responder rate was also significantly improved in patients with highly drug-resistant group ( P = .023). The CGI-C scores indicated significant improvement in both subgroups ( P = .003 and P = .013 for “highly” and “less”, respectively). On the QOLIE-31-P, a significant improvement on the seizure worry subscale for the group with less drug-resistant seizures was noted in USL255-treated patients compared with placebo-treated patients ( P = .003); the overall score and all other subscales were not significantly different for both subgroups. We conclude that USL255 led to significant improvements across multiple outcomes compared with placebo, including in those classified as having highly drug-resistant seizures to prior treatment, making it a valuable treatment option for patients with epilepsy.
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