Trwałe zmniejszenie napadów, uproszczenie leczenia i wysoka adherencja do cenobamianu: 12-miesięczne badanie z praktyki klinicznej u pacjentów z opornością na leki i ultraopornością padaczki ogniskowej
Sustained seizure reduction, treatment simplification, and high retention with cenobamate: A 12-month real-world study in refractory and ultra-refractory focal epilepsy
W skrócie
Badanie wykazało, że lek o nazwie cenobamatu pomaga pacjentom z padaczką, która nie reaguje na inne leki. U pacjentów leczonych przez 12 miesięcy liczba napadów zmniejszyła się o prawie połowę, a 19 procent pacjentów przestało mieć napady. Lek był dobrze tolerowany, choć niektórzy pacjenci doświadczyli senności lub zawrotów głowy.
Oryginalny abstract (angielski)
OBJECTIVE: To assess the 12-month clinical impact of cenobamate (CNB) in adults with drug-resistant focal epilepsy in clinical practice, exploring whether outcomes differed according to prior antiseizure medication (ASM) exposure. METHODS: This single-center, retrospective, observational, real-world study included 91 adults stratified by the number of prior ASMs: ≤ 6 prior ASMs (n = 44) and > 6 prior ASMs (n = 47). Outcomes assessed at 3, 6, and 12 months included monthly seizure frequency, seizure freedom, retention rate, CNB dose, concomitant ASM burden, and adverse drug reactions (ADRs). RESULTS: In the overall cohort, mean monthly seizure frequency decreased from 28.77 at baseline to 22.73 (3 months), 19.37 (6 months), and 14.58 (12 months), representing mean reductions of 21%, 33%, and 49%, respectively. Seizure freedom was achieved by 12% (11/91) of patients at 3 months, 13% (11/87) at 6 months, and 19% (16/82) at 12 months. Treatment retention rate was 100% at 3 months, 95.6% at 6 months, and 90.1% at 12 months. Both subgroups showed clinical benefit, but outcomes were more favorable in patients with ≤ 6 prior ASMs, who had a lower baseline seizure burden and higher 12-month seizure freedom than those with > 6 prior ASMs (29% vs. 10%). At 12 months, most patients were receiving CNB doses of 200 mg or higher, and 79% were maintained on ≤ 2 concomitant ASMs. Overall, 38.5% (35/91) of patients reported at least one ADR (most frequently somnolence, vertigo, and asthenia). SIGNIFICANCE: In this real-world cohort of adults with drug-resistant focal epilepsy, CNB was associated with sustained seizure reduction, high 12-month retention rate, and acceptable tolerability, while most patients were maintained on a low concomitant ASM burden during follow-up. Improvement was observed even in highly treatment-experienced patients, although outcomes were more favorable in those with lower prior ASM burden, supporting the hypothesis that earlier CNB positioning may provide greater efficacy.