A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy

Maguire, Melissa; Ben‐Menachem, Elinor; Patten, Anna; Malhotra, Manoj; Ngo, Leock Y.

doi:10.1016/j.yebeh.2021.108483

Cited by 17 publications

(17 citation statements)

References 39 publications

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“…The main adverse reactions were: irritability, drowsiness, dizziness, nausea, vomiting and abnormal liver function. In a study of 493 epilepsy patients (including adolescents, adults, and the elderly), 28.2% of 243 patients who added perampanel had adverse reactions, mainly dizziness, irritability, balance disorders and weight gain ( 21 ). All adverse reactions were within the controllable range, and there was no situation that seriously affected the patient's vital signs or caused the recurrence and aggravation of epilepsy.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and adverse reactions of perampanel in the treatment of epilepsy in children

Huang

Yang

et al. 2022

Front. Neurol.

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ObjectiveTo observe the clinical effect and adverse reactions of perampanel in the treatment of epilepsy in children.MethodsA retrospective analysis was performed on 83 children with epilepsy who were treated with perampanel in the Department of Pediatric Neurology, Second Affiliated Hospital of Xi'an Jiaotong University from April to August 2021. The treatment status, prognosis and adverse reactions were followed up. The effective rates of different age groups, different seizure types and epilepsy syndromes, and different treatment methods were statistically analyzed. The effective rate and adverse reactions of all patients were statistically analyzed.ResultsThe overall effective rate of perampanel in the treatment of epilepsy was 62.03%, and there was no significant difference in the effective rate of perampanel in the treatment of epilepsy in patients of different ages (P > 0.05). The effective rates of perampanel in the treatment of focal seizures and generalized seizures were 60.38% and 65.38%, and the effective rates of benign childhood epilepsy with centrotemporal spikes (BECT), BECT combined with electrical status epilepticus during sleep (ESES) and frontal lobe epilepsy (FLE) were 88.89, 72.73, and 66.67%. The effective rates of monotherapy and combination therapy were 88.88 and 58.57%, respectively. The above statistical differences were not statistically significant (P > 0.05). In addition, the adverse reaction rate of perampanel treatment was 16.45%, including irritability, drowsiness, dizziness, nausea, vomiting and abnormal liver function.ConclusionPerampanel has a high efficiency and controllable adverse reactions in the treatment of childhood epilepsy. This drug can be used as a reliable choice for long-term use in the treatment of epilepsy in children.

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Section: Discussionmentioning

confidence: 99%

Efficacy and adverse reactions of perampanel in the treatment of epilepsy in children

Huang

Yang

et al. 2022

Front. Neurol.

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“…On the other hand, as a real-world observational study, our study has the advantage of being able to obtain data from large heterogeneous populations of patients outside RCTs. 40 Findings from real-world observational studies such as ours mirror routine clinical practice more closely and could supplement findings from RCTs.…”

Section: Limitations and Strengthmentioning

confidence: 53%

“…Finally, as our follow‐up period was 1 year, longer follow‐ups might be needed to better assess treatment efficacy in those patients with low baseline frequency. On the other hand, as a real‐world observational study, our study has the advantage of being able to obtain data from large heterogeneous populations of patients outside RCTs 40 . Findings from real‐world observational studies such as ours mirror routine clinical practice more closely and could supplement findings from RCTs.…”

Section: Limitations and Strengthmentioning

confidence: 79%

Efficacy and safety of perampanel monotherapy in Chinese patients with focal‐onset seizures: A single‐center, prospective, real‐world observational study

Ma,

Zhu,

Chen

et al. 2023

Epilepsia Open

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ObjectiveEfficacy and safety of perampanel monotherapy for treating focal‐onset seizures (FOS) has been barely studied in China. This observational study aimed to evaluate the efficacy and safety of perampanel monotherapy in treating Chinese patients with FOS.MethodsThis single‐center, prospective, real‐world observational study enrolled patients aged ≥4 years with FOS who visited the Epilepsy Out‐Patient Clinic of Nanjing Brain Hospital affiliated to Nanjing Medical University from January 2020 to December 2021. All patients were treated with perampanel monotherapy. Seizure‐freedom rates after 6 and 12 months of treatment were calculated. Adverse events (AEs) were recorded.ResultsSeventy patients with FOS were enrolled. The mean maintenance perampanel dose was 4.64 ± 1.55 mg/day. The 6‐ and 12‐month retention rates of perampanel monotherapy were 78.6% (55/70) and 70.0% (49/70), respectively. The 6‐ and 12‐month seizure‐freedom rates were 69.84% (44/63) and 65.08% (41/63), respectively. Patients with focal to bilateral tonic–clonic seizures had significantly higher 6‐month and numerically higher 12‐month seizure freedom rates than patients with focal impaired awareness seizures (P = 0.046 and P = 0.204, respectively). Twenty‐six (37.1%) patients experienced treatment‐emergent AEs, and the most common AE was dizziness. Four (5.7%) patients withdrew from the study due to AEs. No new safety concern was observed.SignificanceThis is the first prospective study on the efficacy and safety of perampanel monotherapy in treating Chinese patients with FOS, and perampanel monotherapy was effective and safe in treating Chinese patients aged ≥4 years with FOS up to 12 months. More multicenter, real‐world studies with large sample sizes and longer follow‐ups are needed to further evaluate the long‐term efficacy and safety of perampanel monotherapy.

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“…In a recent meta-analysis, perampanel hydrate did not show the risk of suicidal ideation and suicidal attempt in patients without a history of suicidality; and suicidal ideation (including suicide attempt) was reported in only 3 of 1119 (0.27%) patients treated with perampanel hydrate ( 5 ). Conversely, suicidal ideation, intentional drug overdose, and suicide attempt were reported in 10 of 482 (2.1%) patients treated with perampanel hydrate, who had no medical history of suicidal behavior in an observational 52-week cohort study ( 21 ); although a history of suicidal behavior could not be determined, our results suggest that patients with epilepsy should be monitored for signs of suicidal behavior during treatment with perampanel hydrate. The neurobiological mechanism of suicidality is still unknown.…”

Section: Discussionmentioning

confidence: 65%

“…Antagonism of AMPA receptors by perampanel hydrate might be involved in suicidal behaviors, as indicated by the alteration of AMPA receptor function in patients who completed suicide. In addition, it has been reported that individuals taking perampanel hydrate have a high frequency of aggression, and that aggression is strongly correlated with suicidality risk ( 21 , 24 ). Aggression is associated with increased glutamate levels in the amygdala, hypothalamus, and periaqueductal gray matter, and with stimulation of glutamate receptors ( 25 , 26 ).…”

Section: Discussionmentioning

confidence: 99%

A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

et al. 2023

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Increased suicidality after antiepileptic drug (AED) treatment remains controversial. This study aimed to investigate the occurrence of suicide-related events (SREs) in Japan. SREs signals with AEDs used orally were evaluated by calculating reporting odds ratios (RORs) and information components (ICs) using the Japanese Adverse Drug Event Report (JADER) database from April 2004 to December 2021. Additionally, factors affecting the occurrence of SREs and time-to-onset from the initial AED treatment were analyzed. Of 22 AEDs, 12 (perampanel hydrate, nitrazepam, levetiracetam, clonazepam, clobazam, sodium valproate, phenobarbital, lamotrigine, lacosamide, gabapentin, zonisamide, and carbamazepine) showed signals of SREs. Patients in their 20 and 30 s, female sex, and concomitant use of multiple AEDs affected the occurrence of SREs. In six AEDs, the median time-to-onset of SREs in patients taking all AEDs was <100 days. The pharmacovigilance approach revealed that several AEDs displayed suicidality signals. Female patients, those in their 20 and 30 s, undergoing combination therapy with ≥2 AEDs, and patients early (<100 days from the initial treatment) in the course of AED therapy should be cautioned about SREs.

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A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy

Cited by 17 publications

References 39 publications

Efficacy and adverse reactions of perampanel in the treatment of epilepsy in children

Efficacy and adverse reactions of perampanel in the treatment of epilepsy in children

Efficacy and safety of perampanel monotherapy in Chinese patients with focal‐onset seizures: A single‐center, prospective, real‐world observational study

A pharmacovigilance approach for assessing the occurrence of suicide-related events induced by antiepileptic drugs using the Japanese adverse drug event report database

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