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Psychiatric and behavioral concerns of perampanel with concomitant levetiracetam in children with epilepsy
Jon Soo Kim1, Won Seop Kim2, Won Young Sung3
1Department of Pediatrics, Chungbuk National University Hospital, Cheongju, Republic of Korea.
Insights
Adding perampanel (PER) to epilepsy treatment in children does not increase psychiatric and behavioral adverse events (PBAEs), even when combined with levetiracetam (LEV). This study found no significant differences in PBAE risk, offering reassurance for pediatric epilepsy management.
Area of Science:
- Pediatric Neurology
- Epileptology
- Pharmacovigilance
Background:
- Perampanel (PER) is an effective anti-seizure medication for pediatric epilepsy.
- Concerns exist regarding psychiatric and behavioral adverse events (PBAEs) with PER, particularly when used with levetiracetam (LEV).
Purpose of the Study:
- To investigate the risk profiles for PBAEs when adding PER to pediatric epilepsy treatment.
- To analyze differences in PBAE occurrence and management based on the presence of concomitant LEV.
Main Methods:
- Retrospective review of medical records for children (4-18 years) treated with PER from March 2016 to February 2023.
- Comparison of PBAE occurrence and management between PER without LEV and PER with LEV groups.
- Analysis of risk factors associated with PBAEs.
Main Results:
- Of 94 patients, 36.2% experienced 47 PBAEs; aggression and irritability were most common.
- No significant difference in PBAE occurrence was observed between groups with or without concomitant LEV.
- PBAEs often occurred at lower PER dosages (2-6 mg/day) and were manageable, with 73.5% continuing treatment.
Conclusions:
- Combination therapy with PER and LEV does not elevate the risk of PBAEs in pediatric epilepsy patients.
- Real-world safety data on PER is crucial for pediatric epileptologists.
- PER can be safely used in combination therapy for pediatric epilepsy, with careful monitoring for PBAEs.
Purpose:
Perampanel (PER) is expanding the therapeutic scope for pediatric epilepsy owing to its efficacy and favorable safety profile. However, concerns about psychiatric and behavioral adverse events (PBAEs) in combination therapy with levetiracetam (LEV) continue to contribute to hesitation in its prescription. We investigated the risk profiles for PBAEs when adding PER to pediatric epilepsy treatment and analyzed the differences according to the presence of concomitant LEV.
Methods:
We retrospectively reviewed the medical records of children aged 4-18 years with epilepsy who were prescribed PER as adjunctive therapy from March 2016 to February 2023. We compared the occurrence and management of PBAEs between the PER without LEV and PER with LEV groups. The risk factors for PBAEs were also analyzed.
Results:
Ninety-four patients (53 boys and 41 girls) were included in this study. The median age of total patients at the time of adding PER was 14.9 years (12.3-16.4 years), and 53 patients (56.4 %) had concomitant LEV. Forty-seven PBAEs occurred in 34 patients (36.2 %), with no significant differences depending on whether concomitant LEV is present or not. The most common PBAEs were aggression (14.9 %), irritability (9.6 %), affect lability (7.4 %), and acute psychosis (6.4 %). PBAEs occurred at a lower dosage (2-6 mg/day) in 70.6 % of the patients. In addition, 73.5 % of patients with PBAEs continued PER treatment by follow-up observation or by reducing the PER dosage. No risk factors, such as the presence of concomitant LEV or lamotrigine, any comorbid conditions, higher PER dosage (8-12 mg/day), two or more concomitant anti-seizure medications, and younger age (<13 years) at PER add-on, showed significant associations.
Conclusion:
When expanding the use of anti-seizure medications in pediatric patients, real-world evidence on safety issues is crucial for pediatric epileptologists. We confirmed that combination therapy with PER and LEV did not increase the risk profile of PBAEs.
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