A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents (AMPA): Assessment of Daytime Sleepiness in Patients with Epilepsy Treated with Adjunctive Perampanel
Abstract number :
2.159
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2023
Submission ID :
593
Source :
www.aesnet.org
Presentation date :
12/3/2023 12:00:00 AM
Published date :
Authors :
Presenting Author: Claudio Liguori, MD, PhD – Sleep and Epilepsy Center, Neurology Unit, University Hospital of Rome Tor Vergata, Rome, Italy
Anna Gentile, PhD – Eisai S.r.l., Milan, Italy; Leock Y. Ngo, PhD – Eisai Inc., Nutley, NJ, US; Anna Patten, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK
Rationale: Sleep impairment and daytime sleepiness may affect seizure control and quality of life in patients with epilepsy but can also be caused by epilepsy itself. Anti-seizure medications (ASMs) can improve the sleep-wake cycle by reducing seizure frequency. However, ASMs such as benzodiazepines (clonazepam), phenobarbital, and valproic acid may increase the likelihood of excessive daytime sleepiness (Liguori C et al. Sleep Med Rev. 2021;60:101559). Perampanel is an approved ASM in > 70 countries and territories including Japan, the United States, China, and other countries in Europe and in Asia. The AMPA Study (NCT04257604; Study 501) was a prospective, observational study to evaluate the effectiveness and safety of adjunctive perampanel in routine clinical practice in Italy. This post hoc analysis assesses daytime sleepiness in patients aged ≥ 18 years treated with perampanel at baseline and end of treatment (EoT) in the AMPA study.
Methods: In the AMPA study, patients aged ≥ 12 years with insufficiently controlled focal onset seizures, with/without focal to bilateral tonic-clonic seizures, receiving one to three ASMs were prescribed adjunctive perampanel per the approved indication. The treating physician’s decision to prescribe perampanel was made before, and independently of, their decision to include the patient in the study. In this analysis, daytime sleepiness was assessed by Epworth Sleepiness Scale (ESS) in adult patients at baseline and EoT from the Safety Analysis Set (SAS; those who received ≥ 1 perampanel dose). Each of the eight ESS items were scored on a 4-point (0–3) scale; a high score indicated greater propensity for sleepiness (total ESS score=0–24).
Results: This analysis included 202 patients aged ≥ 18 years who reported baseline ESS scores in the AMPA study (baseline characteristics shown in Table 1). Patients reported a high propensity for sleepiness (per ESS item score=3) at baseline while lying down to rest in the afternoon, watching TV, and as a car passenger for one hour without stop (Table 2). At baseline, patients had a total ESS score (mean [standard deviation]) of 6.3 (4.5). Patients on benzodiazepines/phenobarbital/valproic acid had a higher total ESS score vs patients on other ASMs (6.9 [4.8] vs 5.9 [4.3]). No marked variations were reported in total ESS scores when patients were stratified by age, sex, or number of baseline ASMs. At EoT, 31 patients had a worsening of ≥ 4 points and 29 patients reported an improvement of ≥ 4 points in total ESS scores (Table 2). Treatment-emergent adverse events occurred in 115 (56.9%) patients.
Conclusions: Daytime sleepiness may be reported by patients with epilepsy, in particular those receiving concomitant benzodiazepines, phenobarbital, or valproic acid treatment. The propensity of daytime sleepiness per item was affected both positively and negatively in patients receiving adjunctive perampanel who reported ESS scores in the AMPA study.
Funding: Eisai S.r.l.
Clinical Epilepsy