Time course of drug-related treatment-emergent adverse side effects of brivaracetam

Meador, Kimford J.; Laloyaux, Cédric; Elmoufti, Sami; Gasalla, Teresa; Fishman, Jesse; Martin, Melinda S.; Klein, Pavel

doi:10.1016/j.yebeh.2020.107212

Cited by 11 publications

(7 citation statements)

References 12 publications

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“…Therefore, the study might have missed information about efficacy or missed the onset of TEAEs, as they had not occurred by the cut-off date. However, a study by Meador et al [24] reported that both prevalence and incidence of various TEAEs declined in the course of the first 12 weeks of BRV treatment until no new TEAEs were reported at week 12. Since all the patients in the current study did complete at least three months of BRV treatment, we expect to have included the onset of the majority of TEAEs.…”

Section: Discussionmentioning

confidence: 99%

Brivaracetam for the treatment of refractory epilepsy in patients with prior exposure to levetiracetam: A retrospective outcome analysis

Snoeren

Majoie

Fasen

et al. 2022

Seizure

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Section: Discussionmentioning

confidence: 99%

Brivaracetam for the treatment of refractory epilepsy in patients with prior exposure to levetiracetam: A retrospective outcome analysis

Snoeren

Majoie

Fasen

et al. 2022

Seizure

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“…Common side effects of brivaracetam, include headache, drowsiness, dizziness, fatigue and nausea [ 119 ]. Brivaracetam-related CNS side effects have been shown to peak during the first week, followed by a decrease in the first 6 weeks in prevalence and in the first 3 weeks in incidence, suggesting adaption of the ASD [ 120 ]. Another clinical study performed showed a high rate of central and low systemic side effects, such as irritability and drowsiness (17.3% each), which contradicted with the initial post-marketing studies reporting nervousness, insomnia, depression and anxiety in only 2–3% of patients [ 44 , 45 ].…”

Section: Broad and Narrow Spectrum Anti-seizure Drugsmentioning

confidence: 99%

Elucidating the Potential Side Effects of Current Anti-Seizure Drugs for Epilepsy

Akyüz

Köklü

Ozenen

et al. 2021

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: Over the decades, various interventions have been developed and utilized to treat epilepsy. However, majority of epileptic patients are often first prescribed with anti-epileptic drugs (AED), now known as anti-seizure drugs (ASD), as a first line of defense to suppress their seizures and regain their quality of life. ASDs exert their anti-convulsant effects through various mechanisms of action including regulation of ion channels, blocking of glutamate-mediated stimulating neurotransmitter interaction, and enhancing the inhibitory GABA transmission. About one third of epileptic patients are often resistant to anti-convulsant drugs, while others develop numerous side effects which may lead to treatment discontinuation and further deterioration of quality of life. Common side effects of ASDs include headache, nausea and dizziness. However, more adverse effects such as auditory and visual problems, skin problems, liver dysfunction, pancreatitis and kidney disorders may also be witnessed. Some ASDs may even result in life-threatening conditions as well as serious abnormalities, especially in patients with comorbidities and in pregnant women. Nevertheless, some clinicians had observed a reduction in the development of side effects post individualized ASD treatment. This suggest that a careful and well-informed ASD recommendation to patients may be crucial for an effective and side-effect free control of their seizures. Therefore, this review aimed to elucidate the anticonvulsant effects of ASDs as well as their side effect profile, by discussing their mechanism of action and reported adverse effects based on clinical and preclinical studies, thereby providing clinicians with a greater understanding of the safety of current ASDs.

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“…The incidences of TEAEs (93.4%) and TEAEs leading to discontinuation (12.1%) were highest during the first 3 months of BRV exposure and decreased thereafter. This decreased incidence with exposure duration may reflect adaptation to BRV 12 . The most common TEAEs (≥20% of patients) were nasopharyngitis, pyrexia, pharyngitis, and vomiting, and have been commonly reported in other pediatric trials of ASMs 13–24 .…”

Section: Discussionmentioning

confidence: 95%

“…This decreased incidence with exposure duration may reflect adaptation to BRV. 12 The most common TEAEs (≥20% of patients) were nasopharyngitis, pyrexia, pharyngitis, and vomiting, and have been commonly reported in other pediatric trials of ASMs. [13][14][15][16][17][18][19][20][21][22][23][24] These TEAEs may partially reflect the higher incidence of infectious diseases, including the common cold, in a pediatric population.…”

Section: Seizure Worseningmentioning

confidence: 97%

Long‐term safety and efficacy of adjunctive brivaracetam in pediatric patients with epilepsy: An open‐label, follow‐up trial

Lagae,

Klotz,

Fogarasi

et al. 2023

Epilepsia

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ObjectiveTo evaluate the long‐term safety, tolerability, and efficacy of adjunctive brivaracetam (BRV) treatment in pediatric patients with epilepsy.MethodsPhase 3, open‐label, multicenter, long‐term follow‐up trial (N01266; NCT01364597; patients aged 1 month to <17 years at core trial entry; direct enrollers aged 4 to <17 years) treated with BRV. Outcomes included treatment‐emergent adverse events (TEAEs), behavior assessments (Achenbach Child Behavior Checklist [CBCL]; Behavior Rating Inventory of Executive Function [BRIEF‐P/BRIEF]), and efficacy outcomes (percent change in focal seizure frequency, 50% responder rate for all seizure types for patient subgroups <2 years and ≥2 years of age using daily record card data).ResultsOf 257 patients with ≥1 dose of BRV (141 [54.9%] male; mean age: 8.0 years [SD 4.5]), 36 patients were <2 years of age, and 72.0% of patients had a history of focal seizures. Mean BRV exposure was 3.2 patient‐years. At least one TEAE occurred in 93.4% patients and 32.3% had serious TEAEs. Seven patients died during the trial; no deaths were considered treatment related. Patients ≥2 years of age had a median decrease in 28‐day adjusted focal seizure frequency of 62.9%, and 50.9% had a ≥50% response in all seizures. Patients <2 years of age had a median decrease in 28‐day adjusted focal seizure frequency of 96.9%, and 68.2% had a ≥50% response in all seizures. Kaplan‐Meier estimated treatment retention was 72.7%, 64.5%, 57.8%, 53.3%, 50.1%, and 44.8% at 1, 2, 3, 4, 5, and 6 years, respectively. Mean changes (baseline to last evaluation) for all Achenbach CBCL and BRIEF‐P/BRIEF subscale scores were negative, reflecting stability/slight improvement.SignificanceLong‐term adjunctive BRV treatment was generally well tolerated, efficacious in reducing seizure frequency, and had high retention rates, with generally stable cognitive/behavioral scores in pediatric patients with epilepsy.

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Time course of drug-related treatment-emergent adverse side effects of brivaracetam

Cited by 11 publications

References 12 publications

Brivaracetam for the treatment of refractory epilepsy in patients with prior exposure to levetiracetam: A retrospective outcome analysis

Brivaracetam for the treatment of refractory epilepsy in patients with prior exposure to levetiracetam: A retrospective outcome analysis

Elucidating the Potential Side Effects of Current Anti-Seizure Drugs for Epilepsy

Long‐term safety and efficacy of adjunctive brivaracetam in pediatric patients with epilepsy: An open‐label, follow‐up trial

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