Perampanel in the general population and in people with intellectual disability: Differing responses

Shankar, Rohit; Henley, William; Wehner, Tim; Wiggans, Carys; McLean, Brendan; Pace, Adrian; Mohan, Monica; Sadler, Martin; Doran, Zoë; Hudson, Sharon; Allard, Jon; Sander, Josemir W.

doi:10.1016/j.seizure.2017.05.012

Cited by 22 publications

(30 citation statements)

References 21 publications

(36 reference statements)

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“…Perampanel doses of 6‐8 mg are most common in studies of routine clinical use, and slightly lower doses may be effective in some populations such as older people and those with intellectual disability. For example, people with epilepsy and profound intellectual disability were maintained on a lower perampanel dose (median 4 mg) than people with mild or no intellectual disability (median 6 mg) . Our subpopulation of people aged ≥65 used a lower median dose (6 mg) than the overall population (8 mg).…”

Section: Discussionmentioning

confidence: 82%

“…Investigators who had already gathered data were identified and invited to participate, with the aim of obtaining a full analysis set (FAS) of at least 2000 people. Some centers included here had previously published results . Appropriate ethics committee approvals and informed consent were obtained by centers for the original data acquisition and for incorporating data into this analysis, as required.…”

Section: Methodsmentioning

confidence: 99%

“…Some centers included here had previously published results. [19][20][21][22][23][24][25] Appropriate ethics committee approvals and informed consent were obtained by centers for the original data acquisition and for incorporating data into this analysis, as required. This was an exploratory study; the protocol and analysis plan are available on request; we have stated in this report where we deviated from the original analysis plan; and the authors are prepared to address methodological criticisms of the study (as per ISPOR-ISPE recommendations).…”

Section: Study Design Setting and Patientsmentioning

confidence: 99%

“…Individual-level data from 45 study sites (Table S3) were included: data on 1457 individuals have been published previously, [19][20][21][22][23][24][25] and data on 909 individuals are new to the literature. The FAS comprised 2396 individuals; the evaluable population for retention 2332; the evaluable population for TEAEs 1947; and the evaluable population for seizure freedom 803.…”

Section: Patientsmentioning

confidence: 99%

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Perampanel in routine clinical use across Europe: Pooled, multicenter, observational data

et al. 2018

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Across a large, treatment-resistant population, add-on perampanel was retained for ≥1 year by 48% of individuals, and 9% were seizure-free for ≥6 months. TEAEs were in line with previous reports in routine clinical use, and less frequent than in the clinical trial setting. No new or unexpected TEAEs were seen. Despite the limitations of observational studies, our data indicate that some individuals may derive a marked benefit from the use of perampanel.

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Section: Discussionmentioning

confidence: 82%

Section: Methodsmentioning

confidence: 99%

Section: Study Design Setting and Patientsmentioning

confidence: 99%

Section: Patientsmentioning

confidence: 99%

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Perampanel in routine clinical use across Europe: Pooled, multicenter, observational data

et al. 2018

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“…Published real‐world data with perampanel is mainly from patients with focal seizures, or small case series in specific seizure types, like progressive myoclonic epilepsies or drug‐resistant myoclonic seizures . The phase III perampanel trial in IGE included few patients with myoclonic or absence seizures, so the effect of perampanel on these seizure types could not be determined .…”

Section: Introductionmentioning

confidence: 99%

Perampanel in routine clinical use in idiopathic generalized epilepsy: The 12‐month GENERAL study

et al. 2018

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Summary Objective To analyze the effectiveness and tolerability of perampanel across different seizure types in routine clinical care of patients with idiopathic generalized epilepsy (IGE). Methods This multicenter, retrospective, 1‐year observational study collected data from patient records at 21 specialist epilepsy units in Spain. All patients who were aged ≥12 years, prescribed perampanel before December 2016, and had a confirmed diagnosis of IGE were included. Results The population comprised 149 patients with IGE (60 with juvenile myoclonic epilepsy, 51 generalized tonic–clonic seizures [GTCS] only, 21 juvenile absence epilepsy, 10 childhood absence epilepsy, 6 adulthood absence epilepsy, and one Jeavons syndrome). Mean age was 36 years. The retention rate at 12 months was 83% (124/149), and 4 mg was the most common dose. At 12 months, the seizure‐free rate was 59% for all seizures (88/149); 63% for GTCS (72/115), 65% for myoclonic seizures (31/48), and 51% for absence seizures (24/47). Seizure frequency was reduced significantly at 12 months relative to baseline for GTCS (78%), myoclonic (65%), and absence seizures (48%). Increase from baseline seizure frequency was seen in 5.2% of patients with GTCS seizures, 6.3% with myoclonic, and 4.3% with absence seizures. Perampanel was effective regardless of epilepsy syndrome, concomitant antiepileptic drugs (AEDs), and prior AEDs, but retention and seizure freedom were significantly higher when used as early add‐on (after ≤2 prior AEDs) than late (≥3 prior AEDs). Adverse events were reported in 50% of patients over 12 months, mostly mild or moderate, and irritability (23%), somnolence (15%), and dizziness (14%) were most frequent. Significance In routine clinical care of patients with IGE, perampanel improved seizure outcomes for GTCS, myoclonic seizures, and absence seizures, with few discontinuations due to adverse events. This is the first real‐world evidence with perampanel across different seizure types in IGE.

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Intellectual Disability and Epilepsy

Shankar

Watkins

Brown

2018

Physical Health of Adults With Intellectual and Developmental Disabilities

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Epilepsy in people with intellectual disability is more than the sum of the two conditions. Diagnosis is challenging in the face of cognitive and communication difficulties and in some instances the need to rely on third party information and difficulties in accessing relevant investigations. Treatment is complicated by the lack of evidence specific to intellectual disability and associated neurodevelopmental comorbidities. The presence in many with associated physical and psychological co-morbidity in the face of treatment resistance and increased preponderance to side effects and challenging behavior makes epilepsy management in people with intellectual disability highly complex. It can be argued that specific understanding and skill sets are needed to help manage this vulnerable group. This book chapter looks to outline the unique challenges and questions to treatment this special population poses and looks to provide evidence based up to date answers where available.

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Perampanel in the general population and in people with intellectual disability: Differing responses

Cited by 22 publications

References 21 publications

Perampanel in routine clinical use across Europe: Pooled, multicenter, observational data

Perampanel in routine clinical use across Europe: Pooled, multicenter, observational data

Perampanel in routine clinical use in idiopathic generalized epilepsy: The 12‐month GENERAL study

Intellectual Disability and Epilepsy

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