Mortality Risk After Initiation of Cenobamate or Other Antiseizure Medications
Philip Webber1, Emily Klatte2, Michael Sperling3, William Rosenfeld4, Marc Kamin1, Sean Stern1, Clarence Wade1, Wesley Kerr5
1SK Life Science, Inc., 2Ohio Health Neurological Physicians, 3Thomas Jefferson University, 4Comprehensive Epilepsy Care Center for Children and Adults, 5University of Pittsburgh
Objective:
To retrospectively examine all-cause mortality in patients after initiating cenobamate vs mortality in patients treated with selected antiseizure medications (ASMs) that have similar patterns of use in medication-resistant epilepsy.
Background:
A previous post-hoc analysis of survival in a clinical trial cohort showed that the all-cause standardized mortality ratio (SMR) for cenobamate-treated patients was 1.32 (95% CI: 0.84-2.0), which was not significantly different from the general population.
Design/Methods:
De-identified electronic health records from the Truveta database identified adults (≥18 years) with an epilepsy diagnosis who initiated therapeutic doses of cenobamate or another selected ASM (brivaracetam, clobazam, lacosamide, eslicarbazepine, or perampanel) between 1/1/2020-12/5/2024. New initiations were identified with at least a 1-year washout. Patients were included if they remained on treatment for ≥90 days after initiation. Patients with an epilepsy-related emergency room visit or inpatient admission in the previous 6 months were excluded. Mortality rates were examined for cenobamate and the comparator ASMs with SMRs and Cox proportional hazards. A sensitivity analysis used propensity matching (4:1 ratio) to account for differences in patients who initiated cenobamate.
Results:
3184 patients (51.4% female; mean age 44.8 years) were included. In the overall cohort (n=634 cenobamate; n=2550 other ASMs), 4 and 88 deaths occurred in the cenobamate and comparator ASM groups, respectively; in the propensity-matched cohort (n=361 cenobamate, n=1444 other ASMs), 2 and 36 deaths occurred, respectively. Patients who initiated cenobamate had a mortality rate indistinguishable from that of the general population (SMR 0.69, 95% CI: 0.014-1.37). Patients who initiated comparator ASMs had a higher-than-expected mortality rate (SMR 1.97, 95% CI: 1.56-2.39). Cenobamate was associated with a 68% reduction in mortality rate compared to the other ASMs (HR 0.32, 95% CI: 0.12-0.92; P=0.04). Similar findings were observed after propensity matching.
Conclusions:
Patients treated with cenobamate at therapeutic doses had lower mortality rates than patients treated with selected comparable ASM.
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