Observational study of the effect of perampanel on sleep and daytime sleepiness in adult patients with epilepsy in real-life clinical practice-Reference-Cited by-同舟云学术

Observational study of the effect of perampanel on sleep and daytime sleepiness in adult patients with epilepsy in real-life clinical practice

Published:2024-06-22 Issue:3 Volume:16 Page:79-87
ISSN:2310-1342
Container-title:Neurology, Neuropsychiatry, Psychosomatics
language:
Short-container-title:RJTAO

Author:

Vlasov P. N.¹^ORCID,Karlov V. A.¹^ORCID,Zhidkova I. A.¹^ORCID,Vagina M. A.²^ORCID,Vasilenko A. V.³^ORCID,Goguadze T. M.⁴^ORCID,Danilova T. V.⁵^ORCID,Kirillovskikh O. N.⁶^ORCID,Kovaleva I. Yu.⁷^ORCID,Kornukova Yu. A.⁸^ORCID,Lavrik S. Yu.⁹^ORCID,Larina I. V.⁴^ORCID,Lipatova L. V.¹⁰^ORCID,Tokareva E. R.¹¹^ORCID,Ulitin A. V.¹²^ORCID,Filatova N. V.¹³^ORCID,Yamin M. A.¹⁴^ORCID

Affiliation:

1. Department of Neurology, Russian University of Medicine, Ministry of Health of Russia

2. Consultative and diagnostic clinic, Sverdlovsk Regional Clinical Hospital One

3. Institute of Medical Education, Almazov National Medical Research Center, Ministry of Health of Russia; I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia

4. City Psychiatric Hospital No. 6, City Epileptology Center

5. Kazan State Medical University, Ministry of Health of Russia

6. Sverdlovsk Regional Clinical Neuropsychiatric Hospital for War Veterans; Clinical and Diagnostic Medical Center “Alpha-ritm”

7. Pirogov Russian National Research Medical University, Ministry of Health of Russia

8. Voronezh Regional Clinical Hospital No. 1, Epileptology Center

9. Irkutsk State Medical Academy of Postgraduate Education, branch of Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia

10. Epilepsy Treatment Center, “Ava-Peter” Scandinavia Clinic; St. Petersburg Medical and Social Institute

11. City Hospital No. 1 named after N.I. Pirogov

12. Institute of Medical Education, Almazov National Medical Research Center, Ministry of Health of Russia

13. Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V.I. Krasnopolsky

14. Rostov State Medical University, Ministry of Health of Russia

Abstract

Sleep disorders occur twice as often in epilepsy patients compared to healthy people and have a negative impact on seizure control and general quality of life. International and Russian publications on the effect of perampanel (PER) on sleep emphasise the positive effect of the drug on sleep quality, daytime sleepiness and sleep architecture.Objective: to evaluate the effect of PER (Fycompa®) on sleep quality and daytime sleepiness when used as an adjunct antiepileptic drug (AED) in the treatment of epilepsy in adults.Material and methods. The study included 106 patients aged 18 to 73 years with absolute predominance of focal epilepsy (n=96) who were prescribed PER as an adjunctive AED when previous therapy was insufficient, regardless of whether or not complaints of insomnia were present. The study was conducted from April 2022 to June 2023. The maximum observation period was 12 months. The study was multicenter (10 Russian clinical centres) and designed as an observational study, with patients being monitored prospectively, but some of the indicators were collected retrospectively, taking into account the conditions of real-life clinical practice. We assessed: sleep quality using the Pittsburgh Insomnia Scale (Ya.I. Levin modification), daytime sleepiness according to the Epworth scale, anxiety/depression level (Hospital Anxiety and Depression Scale, HADS), adverse events (AEs), efficacy/tolerability of combination therapy with PER for epilepsy at baseline, and after 1, 3, 6 and 12 months of therapy based on the number of completed questionnaires at each visit in the real-life clinical practice.Results. After a follow-up period of 12 months, the retention rate for complex therapy with PER was 84.9%. PER was discontinued in 15.1% of patients and in only 5.7% due to AEs. The most common AE was dizziness, which was observed with a frequency of over 10% (n=21), followed by irritability (n=9) and drowsiness (n=9) with the same frequency. No new, previously undescribed AEs were observed in this study. The use of PER as an additional AED led to a significant reduction in daytime sleepiness and an improvement in sleep quality after the first month of use; by the 12-month follow-up period, the daytime sleepiness index gradually decreased and reached normal levels, and sleep quality improved. The use of PER as part of a complex therapy led to a significant reduction in the initially elevated anxiety level.Conclusion. The use of PER as an additional AED in adults in dynamics significantly improves sleep quality and reduces daytime sleepiness after the first month of use, regardless of the duration of the disease and the order of PER administration. The use of PER as part of a complex therapy led to a decrease in the initially elevated anxiety level from subclinical to normal.

Publisher

IMA Press, LLC

Reference14 articles.

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