Efficacy and Tolerability of Perampanel as Adjunctive Therapy in Chinese Patients With Focal-Onset Seizures: An Observational, Prospective Study

Zhang, Ranran; Qiao, Shan; Fang, Xiqin; Wang, Kemo; Shi, Yanting; Du, Qianwen; Yang, Tingting; Liu, Xuewu

doi:10.3389/fneur.2021.731566

Cited by 11 publications

(32 citation statements)

References 33 publications

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“…Rohracher et al 19 discovered that a lower likelihood of seizure freedom was associated with enzyme-inducing antiseizure medications (75%) and late (vs early) perampanel add-on (58%). However, unlike the 3 abovementioned reports, the report by Zhang et al 13 confirmed that patients taking enzyme-inducing antiseizure medications with perampanel had a higher maintenance dose than those taking non–enzyme-inducing antiseizure medications (5.3 vs 4.5 mg), but had no reduced perampanel efficacy in seizure control. Our study also demonstrated that there were no significant statistical differences in maintenance dose and response rates between patients taking enzyme-inducing antiseizure medications with perampanel and those taking non–enzyme-inducing antiseizure medications (0.2 ± 0.1 vs 0.2 ± 0.1 mg/kg / d, P > .05).…”

Section: Discussionmentioning

confidence: 84%

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Efficacy, Tolerability, and Safety of Treatment With Perampanel in Pediatric Patients With Epilepsy Aged ≥4 Years: A Real-Life Observational Study

Zhao

Feng

et al. 2023

J Child Neurol

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Purpose: The safety and effectiveness of perampanel in clinical settings involving Chinese pediatric patients are limited, as perampanel has only recently been approved for use in China, in September 2019. We aimed to evaluate the efficacy and tolerability of perampanel as an adjunctive therapy for pediatric patients with epilepsy aged ≥ 4 years in Xinjiang, Northwest China. Methods: Efficacy was assessed by measuring changes in seizure frequency at 3-, 6-, and 12-month follow-up compared with baseline. The baseline was 3 months before the addition of perampanel, and the seizure frequency was based on the patients’ seizure diary. The safety and tolerability depended on the type and frequency of any adverse event during epilepsy treatment across all pediatric patients. Results: Overall, 67 pediatric patients from 2 different hospitals were enrolled in the study. Among the pediatric patients with seizures during the baseline period, the effective rates for all seizure types at 3, 6, and 12 months were 59.1%, 58.7%, and 57.4%, respectively. During perampanel treatment, 34 patients (50.7%) experienced at least 1 adverse reaction. Conclusion: Overall, this real-world retrospective study of pediatric patients validated that perampanel is an effective treatment option as an adjunctive therapy among pediatric patients with epilepsy aged ≥4 years.

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Section: Discussionmentioning

confidence: 84%

“…Zhang et al 13 confirmed the good efficacy and tolerability of adjunctive perampanel in 56 patients aged 14-72 years with focal-onset seizures, with or without combined generalized and focal seizures.…”

mentioning

confidence: 88%

Efficacy, Tolerability, and Safety of Treatment With Perampanel in Pediatric Patients With Epilepsy Aged ≥4 Years: A Real-Life Observational Study

Zhao

Feng

et al. 2023

J Child Neurol

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“…Furthermore, lower doses of combination therapy were also available. [ 30 ] A sudden drop in seizure-freedom rates were observed at the 3-week study timepoint, which may have been due to the titration rate.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and tolerability of adjunctive perampanel in pediatric patients (aged 4–12 years) with refractory epilepsy: An observational study

Chu

Tang

2022

Medicine

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Information on the effects of perampanel in Chinese children ≤12 years of age with refractory epilepsy is limited; thus, we conducted an observational study to assess the effectiveness, safety, and tolerability of adjunctive perampanel in this pediatric population. In this study, we reviewed the medical records of pediatric patients aged 4 to 12 years with refractory epilepsy who were admitted to Children’s Hospital of Soochow University and prescribed perampanel between January 2020 and January 2021. Effectiveness of perampanel was measured by 50% responder rates, seizure-freedom rates, and retention rates for up to 48 weeks. Adverse events were monitored and recorded throughout the study. A total of 34 patients (male, n = 15) who exhibited refractory epilepsy were included in this study, and 64.71% of patients had focal-onset seizures combined with generalized epilepsy. The mean (± standard deviation) age of patients was 7.21 (± 2.12) years, with a mean (± standard deviation) age at seizure onset of 4.57 (± 2.59) years. After the addition of perampanel, the 50% responder rates at 4, 8, 12, 24, 36, and 48 weeks were 37.50% (12/32), 43.75% (14/32), 53.13% (17/32), 59.38% (19/32), 59.38% (19/32), and 62.07% (18/29). Two patients withdrew from perampanel treatment due to adverse events in the first 2 weeks. Adverse events were reported by 44.12% (15/34) of patients, and the retention rates at 36 and 48 weeks were 94.12% (32/34) and 85.29% (29/34), respectively. Overall, perampanel exhibited good effectiveness, safety, and tolerability in the treatment of pediatric patients (aged 4–12 years) with refractory epilepsy. These findings suggest that personalized treatment and better baseline seizure control may increase the responder rate and retention rate of perampanel.

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“…Recently, a prospective real-life study in China confirmed the satisfactory efficacy and tolerability of adjunctive PER in patients ≥14 years of age with focal-onset seizures. However, plasma concentrations of PER were not measured in the study, and the author concerned that they could not precisely assess the influence of concomitant enzyme inducers on the plasma levels of PER associated with seizure control and AEs [41]. Another retrospective observational study has suggested the effectiveness and safety of PER in Chinese pediatric patients (2-14 years) with refractory epilepsy [42].…”

Section: Plasma Concentrationsmentioning

confidence: 99%

LC-MS/MS assay for the therapeutic drug monitoring of perampanel in children with drug-resistant epilepsy

Dai

Long

et al. 2023

AChrom

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Perampanel (PER) is the first clinically available selective antagonist of α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor approved globally for the treatment of epilepsy. Studies have recently underlined the significant association between dose-exposure-effect-adverse events of PER in patients with epilepsy, so the therapeutic drug monitoring (TDM) of PER is critical in clinical practices, especially for pediatric patients with drug-resistant epilepsy. Due to several limits in previous published analytical methods, herein, we describe the development and validation of a novel liquid chromatography tandem mass spectrometry (LC-MS/MS) method for monitoring PER in human plasma samples. Protein precipitation method by acetonitrile containing PER-d5 as internal standard was applied for the sample clean-up. Formic acid (FA, 0.2 mM) in both aqueous water and acetonitrile were used as the mobile phases and the analyte was separated by an isocratic elution. Qualification and quantification were performed under positive electrospray ionization (ESI) mode using the m/z 350.3 → 219.1 and 355.3 → 220.0 ions pairs transitions for PER and PER-d5, respectively. Potential co-medicated anti-seizure medications (ASMs) have no interference to the analysis. Calibration curves were linear in the concentration range of 1.00–2,000 ng mL−1 for PER. The intra- and inter-batch precision, accuracy, recovery, dilution integrity, and stability of the method were all within the acceptable criteria and no matrix effect or carryover was found. This method was then successfully implemented on the TDM of PER in Chinese children with drug-resistant epilepsy. We firstly confirmed the apparent inter- and intra-individual PER concentration variabilities and potential drug-drug interactions between PER and several concomitant ASMs occurred in Chinese pediatric patients, which were also in line with previous studies in patients of other race.

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Efficacy and Tolerability of Perampanel as Adjunctive Therapy in Chinese Patients With Focal-Onset Seizures: An Observational, Prospective Study

Cited by 11 publications

References 33 publications

Efficacy, Tolerability, and Safety of Treatment With Perampanel in Pediatric Patients With Epilepsy Aged ≥4 Years: A Real-Life Observational Study

Efficacy, Tolerability, and Safety of Treatment With Perampanel in Pediatric Patients With Epilepsy Aged ≥4 Years: A Real-Life Observational Study

Effectiveness and tolerability of adjunctive perampanel in pediatric patients (aged 4–12 years) with refractory epilepsy: An observational study

LC-MS/MS assay for the therapeutic drug monitoring of perampanel in children with drug-resistant epilepsy

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