Efficacy and safety of Cenobamate: a multicenter, retrospective evaluation of real-world clinical practice

Abstract

Introduction

Epilepsy is a common neurological disorder, with approximately one-third of patients experiencing drug-resistant epilepsy (DRE), which imposes significant clinical, social, and economic burdens. Cenobamate, a novel antiseizure medication (ASM), was included to the Polish therapeutic framework in March 2023.

Materials and Methods

This retrospective, multicenter study was conducted at 19 centers. Medical records of adult patients with DRE treated with cenobamate for at least six months were reviewed. Collected data included demographic characteristics, seizure frequency, treatment regimens, and adverse events (AEs). Descriptive statistical methods were employed to assess outcomes, with the primary efficacy endpoint of ≥50 % reduction in seizure frequency.

Results

The study cohort consisted of 475 patients with a median age of 37 years. Treatment with cenobamate (median maximal daily dose, 250 mg) resulted in a ≥ 50 % reduction in seizure frequency in 61.9 % of patients, with 16.5 % achieving seizure freedom during the final three months of observation, with better responses when the treatment was initiated earlier. The burden of polytherapy decreased, as 69.7 % of patients reduced or discontinued concomitant ASMs. Adverse events were reported in 48.8 % of patients, most commonly somnolence and dizziness, with no cases of severe dermatological reactions. Discontinuation of cenobamate occurred in 12 % of patients.

Discussion

Cenobamate demonstrated notable efficacy in patients with treatment-resistant epilepsy, and its early initiation may improve outcomes. Treatment has a large potential for significant simplification of treatment regimens. Adverse events were manageable.

Conclusions

Cenobamate is a highly effective and well-tolerated ASM for patients with DRE, offering significant clinical benefits, including improved seizure control and reduced polytherapy.