Cenobamate May Cut Seizures in Drug-Resistant Epilepsy

TOPLINE:

According to a real-world study, cenobamate was effective in patients with drug-resistant epilepsy (DRE), with 49.3% of patients achieved a 5src% or greater reduction in seizure frequency at 3 months. Mild to moderate adverse drug reactions occurred in 3src.9% of patients and mostly resolved over time.

METHODOLOGY:

• Researchers conducted a multicentre, retrospective, observational study across 19 hospitals in France, Germany, and the United Kingdom and analysed data of 298 patients with DRE (mean age, 37 years; 56.7% men) who received at least one dose of cenobamate during Early Access Programs (EAPs) from 2src2src to 2src22.
• Participants had a median epilepsy duration of 22.2 years and a median of nine previously failed antiseizure medications (ASMs). About 41.9% of participants had previous epilepsy surgery, including vagus nerve stimulation.
• The analysis included evaluation points at baseline and 1 and 3 months after cenobamate initiation, followed by 3, 6, and 12 months after the completion of maintenance.
• Data were obtained from clinical records, and assessments were performed during the EAP.
• The primary endpoint was the 5src% responder rate; secondary endpoints were the percentage of seizure-free patients, retention rate, average dose during maintenance, percentage change in seizure frequency, changes from baseline in the number of concomitant ASMs, adverse events and drug reactions, and withdrawal due to adverse drug reactions.

TAKEAWAY:

• After 3 months of maintenance, 49.3% of patients achieved a 5src% or greater reduction in seizure frequency, with a median percentage reduction in seizure frequency from baseline of 49.1%.
• Complete seizure freedom was achieved by 13.6% of patients, whereas a 9src% or greater and a 75% or greater reduction in seizure frequency were reported in 2src.src% and 33.6% of patients, respectively.
• The retention rate decreased from 96.6% at 1-month cenobamate start to 69.7% at 12-month maintenance.
• Adverse drug reactions occurred in 3src.9% of patients, with asthenia, dizziness, and somnolence being the most frequent. About 1.src% of patients experienced seven serious adverse drug reactions, all during titration.

IN PRACTICE:

“Our study evidenced that CNB [cenobamate] can be considered generally well tolerated and effective in highly refractory focal or combined generalized and focal epilepsy,” the authors wrote.

SOURCE:

This study was led by Sylvain Rheims, Hospices Civils de Lyon and Lyon 1 University, Lyon, France. It was published online on March 22 in Epilepsia Open.

LIMITATIONS:

This retrospective study relied on clinical records for seizure data, which may not be as accurate as those in prospective trials. As the EAP’s conclusion time varied between countries, only a small proportion of the 298 patients completed the full long-term observation period, significantly decreasing the number of patients observed over time.

DISCLOSURES:

This study was funded by Angelini Pharma. Several authors reported having various ties with sources including pharmaceutical companies. Details are provided in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.