Clinical relevance of patients with epilepsy included in clinical trials

Tlusta, Eva; Handoko, K.; Majoie, Marian; Egberts, Toine C. G.; Vlcek, Jirí; Heerdink, Eibert R.

doi:10.1111/j.1528-1167.2008.01618_2.x

Cited by 21 publications

(16 citation statements)

References 6 publications

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“…Previous researches have reported that employment is a significant predictor of psychological distress [24, 29]. Table 1 also shows that even though 46% of the participants have education up to matriculation, however the unemployment rate is high (42%).…”

Section: Discussionmentioning

confidence: 78%

Assessment of Psychological Distress in Epilepsy: Perspective from Pakistan

Sahar

2012

Epilepsy Research and Treatment

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The unpredictable nature & elongated course of epilepsy affect all dimensions (physical, psychological, and social) of an individual's life. People with the diagnosis of epilepsy are a high-risk group for different psychiatric problems that is anxiety, depression as well as social problems (marriage, education, and daily activities). The findings of present research revealed high rate (70%) of psychological distress among fifty adult individuals with epilepsy. It was also found that people with uncontrolled epilepsy experience high level of psychological distress (100%) as compared to those with controlled (42%). Demographic and clinical factors associated with distress include lack of occupation, the presence of an underlying disabling condition (with treatment), and the severity of epilepsy. The finding generated here showed that 13 out of 19 females with epilepsy reported psychological distress. It was also found that none of these women was employed (a cultural specific phenomenon) with a slightly high number of unmarried females (74%). So by understanding the relationship between clinical and psychosocial variables, a good management plan can be devised with a focus on social and gender differences. The present research can also help to increase the awareness and to lower the stigmatization related to epilepsy.

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Section: Discussionmentioning

confidence: 78%

Assessment of Psychological Distress in Epilepsy: Perspective from Pakistan

Sahar

2012

Epilepsy Research and Treatment

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“…Approval for the treatment of generalized-onset tonic–clonic seizures in IGE was based on the findings of one Phase III, randomized, double-blind, placebo-controlled trial [ 12 ]. Real-world clinical practice data complement evidence from clinical trials by providing information on people with epilepsy (PWE) who are more diverse in terms of clinical characteristics than those recruited for clinical trials [ 13 – 15 ]. In addition, they provide pragmatic information on the dosing and titration schedules employed in clinical practice, which are individualized and applied on a patient-by-patient basis, rather than according to a pre-defined clinical trial protocol [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice

et al. 2021

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The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3, 6, and 12 months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (≥ 50% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12 months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8 months. The 50% responder rate was 58.3% at 12 months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (≥ 5% of PWE) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12 months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and/or generalized epilepsy in everyday clinical practice.

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“…However, while necessary for regulatory approval, the controlled environment and criteria for these types of trials do not account for variabilities that are part of everyday real-world clinical practice. For example, these studies tend to exclude PWE who may be most at risk for BAEs (e.g., patients with a history of comorbid psychiatric conditions), are limited in time and patient exposure to the drug, and often do not allow the use of at least some concomitant medications and supplements, which may influence the incidence and/or severity of BAEs [16,19,20]. Therefore, it is unlikely that these data represent the experience with medications in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Behavioral adverse events with brivaracetam, levetiracetam, perampanel, and topiramate: A systematic review

Steinhoff

Klein

Klitgaard

et al. 2021

Epilepsy & Behavior

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To understand the currently available post-marketing real-world evidence of the incidences of and discontinuations due to the BAEs of irritability, anger, and aggression in people with epilepsy (PWE) treated with the anti-seizure medications (ASMs) brivaracetam (BRV), levetiracetam (LEV), perampanel (PER), and topiramate (TPM), as well as behavioral adverse events (BAEs) in PWE switching from LEV to BRV. Methods: A systematic review of published literature using the Cochrane Library, PubMed/MEDLINE, and Embase was performed to identify retrospective and prospective observational studies reporting the incidence of irritability, anger, or aggression with BRV, LEV, PER, or TPM in PWE. The incidences of these BAEs and the rates of discontinuation due to each were categorized by ASM, and where possible, weighted means were calculated but not statistically assessed. Behavioral and psychiatric adverse events in PWE switching from LEV to BRV were summarized descriptively. Results: A total of 1500 records were identified in the searches. Of these, 44 published articles reporting 42 studies met the study criteria and were included in the data synthesis, 7 studies were identified in the clinical trial database, and 5 studies included PWE switching from LEV to BRV. Studies included a variety of methods, study populations, and definitions of BAEs. While a wide range of results was reported across studies, weighted mean incidences were 5.6% for BRV, 9.9% for LEV, 12.3% for PER, and 3.1% for TPM for irritability; 3.3%* for BRV, 2.5% for LEV, 2.0% for PER, and 0.2%* for TPM for anger; and 2.5% for BRV, 2.6% for LEV, 4.4% for PER, and 0.5%* for TPM for aggression. Weighted mean discontinuation rates were 0.8%* for BRV, 3.4% for LEV, 3.0% for PER, and 2.2% for TPM for irritability and 0.8%* for BRV, 2.4% for LEV, 9.2% for PER, and 1.2%* for TPM for aggression. There were no discontinuations for anger. Switching from LEV to BRV led to improvement in BAEs in 33.3% to 83.0% of patients (weighted mean, 66.6%).*Denotes only 1 study.

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Clinical relevance of patients with epilepsy included in clinical trials

Cited by 21 publications

References 6 publications

Assessment of Psychological Distress in Epilepsy: Perspective from Pakistan

Assessment of Psychological Distress in Epilepsy: Perspective from Pakistan

PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice

Behavioral adverse events with brivaracetam, levetiracetam, perampanel, and topiramate: A systematic review

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