Adjunctive Perampanel in Older Patients With Epilepsy: A Multicenter Study of Clinical Practice

Lattanzi, Simona; Cagnetti, Claudia; Foschi, Nicoletta; Ciuffini, Roberta; Osanni, Elisa; Chiesa, Valentina; Dainese, Filippo; Canevini, Maria Paola; Evangelista, Giacomo; Paladin, Francesco; Bartolini, Emanuele; Ranzato, Federica; Nilo, Annacarmen; Pauletto, Giada; Marino, Daniela; Rosati, Eleonora; Bonanni, Paolo; Marrelli, Alfonso

doi:10.1007/s40266-021-00865-3

Cited by 25 publications

(37 citation statements)

References 28 publications

(39 reference statements)

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“…During the 1-year study period, the overall rate of treatment discontinuation was about 25%, which was similar to that observed in other studies focusing on BRV and newer ASMs in clinical practice, including eslicarbazepine, perampanel, and lacosamide [ 21 – 29 , 34 – 36 ]. The main reason for drug withdrawal was inadequate efficacy, and BRV was interrupted within the first 3 months of treatment in almost half of the cases.…”

Section: Discussionsupporting

confidence: 84%

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

et al. 2021

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Background In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drugresistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Objective This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice. Methods The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure-freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed. Results A total of 1029 patients with a median age of 45 years (33-56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs (p < 0.001); the corresponding values for ≥ 50% seizure frequency reduction were 47.9%, 29.7%, and 42.8% (p < 0.001). There were no statistically significant differences in seizure freedom and seizure response rates by use of strong EiASMs. The rates of seizure freedom (20.0% vs. 16.6%; p = 0.341) and seizure response (39.7% vs. 26.9%; p = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, and were less common in patients treated with BRV and concomitant SCBs than those not treated with SCBs (28.9% vs. 39.8%; p = 0.017). ConclusionThe BRIVAFIRST provided real-world evidence on the effectiveness of BRV in patients with focal epilepsy irrespective of LEV history and concomitant ASMs, and suggested favourable therapeutic combinations.

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Section: Discussionsupporting

confidence: 84%

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

et al. 2021

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“…Another study reported the effectiveness and tolerability of adjunctive perampanel in patients aged ≥65 years (N=92) across 12 Italian epilepsy centers. 20 Mean perampanel doses were 4, 5, and 6 mg/day at 3, 6, and 12 months, respectively. Adjunctive perampanel was associated with improved seizure control: at 12 months, 57.6% of the patients achieved ≥50% reduction in baseline monthly seizure frequency, and 23.9% were seizure free.…”

Section: Key Clinical and Real-world Evidence On Perampanelmentioning

confidence: 97%

Optimal Use of Perampanel in Elderly Asian Patients with Epilepsy: Expert Opinion

Huang¹,

Boonyapisit²,

Gunadharma³

et al. 2022

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Managing epilepsy in the elderly remains complicated largely due to factors related to aging. In this population, management practices are increasingly shifting towards the use of newer-generation anti-seizure medications (ASMs) as they are generally associated with better tolerability and safety profiles than older ones. Perampanel is a new ASM with broad-spectrum efficacy and a favorable safety profile. However, because of the lack of information and experience in its use, the prescription of perampanel has not been optimized in the elderly in the real-world setting in Asia. A group of epilepsy experts across the region convened at a series of virtual meetings to share their experience and discuss recommendations on perampanel use in elderly patients, including dose optimization, considerations with treatment initiation, and strategies to manage adverse events and maximize tolerability. This article summarizes key clinical and real-world evidence for perampanel in the elderly and consolidates the experts’ opinions on optimizing perampanel use in elderly Asian patients with epilepsy, providing practical guidance for clinicians to address challenges related to treatment initiation and tolerance.

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“…As a result of metabolic derangements, an increased incidence of cardiovascular disease, and a high potential of influencing the metabolism of drugs commonly prescribed in the elderly, first-generation and enzyme-inducing antiseizure medications (ASMs) are preferably avoided [ 6 , 7 ]. Accordingly, the evaluation of the efficacy and tolerability profile of the newer ASMs in older adults has an important clinical relevance [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Adjunctive Brivaracetam in Older Patients with Focal Seizures: Evidence from the BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST)

et al. 2022

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Background The management of epilepsy in older adults has become part of daily practice because of an aging population. Older patients with epilepsy represent a distinct and more vulnerable clinical group as compared with younger patients, and they are generally under-represented in randomized placebo-controlled trials. Real-world studies can therefore be a useful complement to characterize the drug’s profile. Brivaracetam is a rationally developed compound characterized by high-affinity binding to synaptic vesicle protein 2A and approved as adjunctive therapy for focal seizures in adults with epilepsy. Objective The aim of this study was to assess the 12-month effectiveness and tolerability of adjunctive brivaracetam in older patients (≥65 years of age) with epilepsy treated in a real-world setting. Methods The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a 12-month retrospective multicenter study including adult patients prescribed adjunctive brivaracetam. Effectiveness outcomes included the rates of seizure response (≥50% reduction in baseline seizure frequency), seizure freedom, and treatment discontinuation. Safety and tolerability outcomes included the rate of treatment discontinuation due to adverse events and the incidence of adverse events. Data were compared for patients aged ≥65 years of age (‘older’) vs those aged <65 years (‘younger’). Results There were 1029 patients with focal epilepsy included in the study, of whom 111 (10.8%) were aged ≥65 years. The median daily dose of brivaracetam at 3 months was 100 [interquartile range, 100–175] mg in the older group and 100 [100–200] mg in the younger group ( p = 0.036); it was 150 [100–200] mg in both groups either at 6 months ( p = 0.095) or 12 months ( p = 0.140). At 12 months, 49 (44.1%) older and 334 (36.4%) younger patients had a reduction in their baseline seizure frequency by at least 50% ( p = 0.110), and the seizure freedom rates were 35/111 (31.5%) and 134/918 (14.6%) in older and younger groups, respectively ( p < 0.001). During the 1-year study period, 20 (18.0%) patients in the older group and 245 (26.7%) patients in the younger group discontinued brivaracetam ( p = 0.048). Treatment withdrawal because of insufficient efficacy was less common in older than younger patients [older: n = 7 (6.3%), younger: n = 152 (16.6%); p = 0.005]. Adverse events were reported by 24.2% of older patients and 30.8% of younger patients ( p = 0.185); the most common adverse events were somnolence, nervousness and/or agitation, vertigo, and fatigue in both study groups. Conclusions Adjunctive brivaracetam was efficacious, had good tolerability, and n...

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Adjunctive Perampanel in Older Patients With Epilepsy: A Multicenter Study of Clinical Practice

Cited by 25 publications

References 28 publications

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

Optimal Use of Perampanel in Elderly Asian Patients with Epilepsy: Expert Opinion

Adjunctive Brivaracetam in Older Patients with Focal Seizures: Evidence from the BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST)

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