更新于：2024-11-04
Shire Development LLC
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Pennsylvania, United States
更新于：2024-11-04
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Long-term Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
Long-term Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
Phase II/III Study of S-877489 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
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2020-11-01Epilepsy & behavior : E&B3区 · 医学
Burden of disease in patients with a history of status epilepticus and their caregivers
3区 · 医学
Article
作者: Niemira, Jeff ; King-Stephens, David ; Stolper, Robert ; Krogh, Calvin ; Benitez, Arturo ; Fournier, Martha ; Lu, Mei ; Spalding, William ; Bettles, Matthew ; Wheless, James
OBJECTIVE:
Status epilepticus (SE) is a life-threatening neurological emergency with the potential for wide-ranging impact on patients and caregivers. In this study, the burden of disease in patients with a history of SE and their caregivers was assessed.
METHODS:
Adult patients as well as caregivers of children, adolescents, and adults who had experienced ≥1 SE event in the past 24 months completed an online survey. Functional, social, emotional, and economic burden in patients and caregivers was assessed. Burden was measured through concept-targeted questionnaires, including the US Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life 4 (HRQoL-4) and the Work Productivity and Activity Impairment (WPAI) instruments.
RESULTS:
The 198 respondents comprised 49 adult patients, 51 caregivers of children, 47 caregivers of adolescents, and 51 caregivers of adults. Most patients (93.9%) were diagnosed with epilepsy. Patients' daily activities were highly affected, and many respondents reported a substantial long-term physical and mental impact on patients. The mean CDC HRQoL-4 score for unhealthy days per month ranged from 11.1 for caregivers of adults to 16.9 for caregivers of children. WPAI scores demonstrated a substantial impact on the ability of adult patients and all caregivers to work. Among respondents, caregivers of children reported the highest absenteeism from work (20%) and the lowest employment rate (33%). Proportions of caregivers reporting that their daily social life was impacted at least 'some of the time' ranged from 80% to 92%, with nearly half (47%) of caregivers of children responding that their social life was impacted 'all the time'.
CONCLUSIONS:
Status epilepticus episodes place a high burden on patients and caregivers. Notably, the burden appeared high across a variety of domains. This study highlights that the burden of disease is pronounced and wide-reaching and goes beyond the immediate physical and medical impact of an SE episode.
2020-11-01Epilepsy & behavior : E&B3区 · 医学
Epidemiology of status epilepticus in the United States: A systematic review
3区 · 医学
Review
作者: Lu, Mei ; Bergamasco, Aurore ; Spalding, William ; Fournier, Martha ; Benitez, Arturo ; Moride, Yola ; Faure, Mareva
OBJECTIVES:
Convulsive status epilepticus (CSE) is a life-threatening neurologic emergency, which is defined by the International League Against Epilepsy (ILAE) as bilateral tonic-clonic seizure activity lasting longer than 5 min, while absence status epilepticus (SE) and focal SE are specified as exceeding 10 min. Epidemiological evidence on SE is currently lacking, and the incidence is not well-known, especially in light of changes in the ILAE criteria for SE. The objectives of this systematic literature review were to describe the epidemiology of SE in the US population and the associated burden of illness.
METHODS:
A systematic review, including literature and pragmatic searches, was conducted. Literature searches were performed using MEDLINE, Embase, BIOSIS, and Web of Science electronic databases from inception to February 2019. Pragmatic searches of the gray literature were carried out using Google, Google Scholar, conference proceedings, and ClinicalTrials.gov to identify additional sources. Only US-based studies or multinational studies reporting US data of interest were included.
RESULTS:
In total, 69 sources were identified. The incidence of all SE in patients of all ages in the USA ranged from 18.3 to 41 per 100,000 people per year. Incidence of all-age CSE rose from 3.5 (1979) to 12.5 (2010) per 100,000 people per year. Status epilepticus incidence followed a bimodal (U-shaped) distribution, with the highest estimates in the first years of life (0-4 years) and after 60 years. Mortality associated with SE varied from 21% over 30 days to 31.2% over 10 years. For CSE, two studies reported similar in-hospital mortalities (9.2% and 10.7%). Median healthcare costs related to SE admission were approximately US$14,500 per adult (17-45 years) and US$8000 per child (0-16 years).
CONCLUSIONS:
There is a lack of recent data on the epidemiology and healthcare burden associated with SE. Reports of SE incidence in the USA are highly variable and predate the 2015 ILAE definition of SE. However, the available data suggest a high burden of illness.
2017-12-01Journal of attention disorders2区 · 医学
Treatment With Lisdexamfetamine Dimesylate Improves Self- and Informant-Rated Executive Function Behaviors and Clinician- and Informant-Rated ADHD Symptoms in Adults: Data From a Randomized, Double-Blind, Placebo-Controlled Study
2区 · 医学
Article
作者: Weisler, Richard ; Deas, Patrick ; Adeyi, Ben ; Adler, Lenard A. ; Ginsberg, Lawrence ; Dirks, Bryan
Objective: To examine the level of agreement between self- and observer-reported ratings of ADHD symptoms and executive function (EF) behaviors in adults with moderate to severe ADHD and EF deficits. Method: During a 10-week, randomized, double-blind, placebo-controlled study, the effect of lisdexamfetamine dimesylate (LDX) on EF was assessed by self-report and informant report (Behavior Rating Inventory of Executive Function–Adult Version), and ADHD symptoms were assessed by clinician- and informant-rated scales (ADHD Rating Scale IV with adult prompts and Conners’ Adult ADHD Rating Scales–Observer Report: Short Version, respectively). Post hoc analysis used Pearson correlations to assess relationships between self- and informant-rated EF and clinician- and informant-rated ADHD symptoms. Results: Correlations between self-ratings versus informant ratings and clinician versus informant ratings were greater at Week 10/early termination (EF: placebo [0.5231–0.6085], LDX [0.3543–0.5167]; ADHD symptoms: placebo [0.4169], LDX [0.4004]) versus baseline (EF: placebo [0.3208–0.5023], LDX [0.2852–0.3439]; ADHD symptoms: placebo [0.1511], LDX [–0.0408]). Conclusion: LDX improved EF and ADHD symptoms, based on participant, informant, and clinician ratings. Increased rater agreement over time may reflect improved symptom awareness.
2023-09-12
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