PROVE—Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients

2022 ◽  
pp. 088307382110476
Author(s):  
Eric Segal ◽  
Katherine Moretz ◽  
James Wheless ◽  
Patricia Penovich ◽  
Marcelo Lancman ◽  
...  
Keyword(s):  
Medical Records ◽  
Interim Analysis ◽  
Pediatric Patients ◽  
Clinical Care ◽  
Retention Rates ◽  
Routine Clinical Care ◽  
Adolescent Patients ◽  
Patients With Epilepsy ◽  
Oral Doses ◽  
Phase Iv

PROVE is a retrospective, phase IV study assessing retention, dosing, efficacy, and safety of perampanel when administered to patients during routine clinical care. We report an interim analysis of preadolescent (1 to <12 years) and adolescent (12 to <18 years) patients. Data were obtained from medical records of patients with epilepsy initiating perampanel after January 1, 2014; cut-off date for this analysis was October 10, 2018. Overall, 151 preadolescent and 183 adolescent patients were included. Retention rates following 24 months on perampanel were 42.5% (preadolescent subgroup; n = 31/73) and 55.7% (adolescent subgroup; n = 54/97). Treatment-emergent adverse events occurred in 53 (35.1%) preadolescent (most common: aggression, irritability, and somnolence) and 78 (42.6%) adolescent patients (most common: somnolence, aggression, and dizziness). These data indicate that daily oral doses of perampanel are generally well tolerated during routine clinical care, with favorable retention rates for ≤2 years, in patients aged 1 to <18 years.

scholarly journals Perampanel in real‐world clinical care of patients with epilepsy: Interim analysis of a phase IV study

2020 ◽  
Author(s):  
James Wheless ◽  
Robert T. Wechsler ◽  
Marcelo Lancman ◽  
Sami Aboumatar ◽  
Anna Patten ◽  
...  
Keyword(s):  
Real World ◽  
Interim Analysis ◽  
Clinical Care ◽  
Patients With Epilepsy ◽  
Phase Iv

scholarly journals Treatment with compounded fluticasone suspension improves the clinical, endoscopic, and histologic features of eosinophilic esophagitis

2020 ◽  
Author(s):  
Corey J Ketchem ◽  
Craig C Reed ◽  
Zoe Stefanadis ◽  
Evan S Dellon
Keyword(s):  
Eosinophilic Esophagitis ◽  
Medical Records ◽  
Clinical Care ◽  
The United States ◽  
Food Impaction ◽  
Histologic Response ◽  
Off Label ◽  
Endoscopic Findings ◽  
Loss Of Response ◽  
Routine Clinical Care

Summary No approved medication exists for the treatment of eosinophilic esophagitis (EoE) in the United States, which forces patients to utilize off-label drugs and/or create their own formulations. We assessed the efficacy of a standardized compounded fluticasone suspension. To do this, we performed a retrospective cohort study identifying all EoE patients treated with compounded fluticasone. Compounded fluticasone was prescribed during routine clinical care and dispensed by a specialty compounding pharmacy. Clinical data were extracted from medical records. Outcomes (symptomatic, endoscopic, and histologic) were assessed after the initial and last compounded fluticasone treatment in our system. There were 27 included patients (mean age 34.2; 67% male; 96% white) treated for a mean length of 5.4 ± 4.4 months. The majority (89%) previously utilized dietary elimination or topical corticosteroids, and many (75%) had primary non-response or secondary loss of response to these treatments. After starting compounded fluticasone, symptoms and endoscopic findings improved [dysphagia (89 vs. 56%, P = 0.005), food impaction (59 vs. 4%, P = 0.003), heartburn (26 vs. 4%, P = 0.01), chest pain (26 vs. 8%, P = 0.05), white plaques (63 vs. 32%; P = 0.005), furrows (81 vs. 60%; P = 0.06), and edema (15 vs. 4%; P = 0.16)]. The median of the peak eosinophil counts decreased from 52 to 37 eos/hpf (P = 0.10) and 35% of patients achieved &lt;15 eos/hpf. In conclusion, compounded fluticasone provided a significant improvement in symptoms and endoscopic findings, with more than a third achieving histologic response in a treatment refractory EoE population. Compounded fluticasone should be considered as an EoE management option.

scholarly journals Pediatric musculoskeletal pain in the emergency department: a medical record review of practice variation

CJEM ◽  
2014 ◽  
Vol 16 (06) ◽  
pp. 449-457 ◽  
Author(s):  
Janeva Kircher ◽  
Amy L. Drendel ◽  
Amanda S. Newton ◽  
Sukhdeep Dulai ◽  
Ben Vandermeer ◽  
...  
Keyword(s):  
Emergency Department ◽  
Medical Records ◽  
Pediatric Patients ◽  
Clinical Care ◽  
Practice Variation ◽  
Primary Objective ◽  
Fracture Dislocation ◽  
Pain Scores ◽  
Pediatric Presentation ◽  
Children's Pain

ABSTRACTObjective:Musculoskeletal (MSK) injuries are a common, painful pediatric presentation to the emergency department (ED). The primary objective of this study was to describe current analgesic administration practices for the outpatient management of children’s MSK pain, both in the ED and postdischarge.Methods:We reviewed the medical records of consecutive pediatric patients evaluated in either a pediatric or a general ED (Edmonton, Alberta) during four evenly distributed calendar months, with a diagnosis of fracture, dislocation, strain, or sprain of a limb. Abstracted data included demographics, administered analgesics, pain scores, discharge medication advice, and timing of clinical care.Results:A total of 543 medical records were reviewed (n 5 468 pediatric ED, n 5 75 general ED). Nineteen percent had documented prehospital analgesics, 34% had documented in-ED analgesics, 13% reported procedural sedation, and 24% documented discharge analgesia advice. Of those children receiving analgesics in the ED, 59% (126 of 214) received ibuprofen. Pain scores were recorded for 6% of patients. At discharge, ibuprofen was recommended to 47% and codeine-containing compounds to 21% of children. The average time from triage to first analgesic in the ED was 121 6 84 minutes.Conclusions:Documentation of the assessment and management of children’s pain in the ED is poor, and pain management appears to be suboptimal. When provided, ibuprofen is the most common analgesic used for children with MSK pain. Pediatric patients with MSK pain do not receive timely medication, and interventions must be developed to improve the ‘‘door to analgesia’’ time for children in pain.

scholarly journals Comparative Efficacy of Levetiracetam for Epilepsy in School-Aged Children with Intellectual Disability and Normal Intelligence

2021 ◽  
Vol 11 (11) ◽  
pp. 1452
Author(s):  
Ja Un Moon ◽  
Ji Yoon Han
Keyword(s):  
Intellectual Disability ◽  
Side Effects ◽  
Pediatric Patients ◽  
Reduction Rate ◽  
Retrospective Chart Review ◽  
Retention Rates ◽  
Pediatric Epilepsy ◽  
Normal Intelligence ◽  
School Aged Children ◽  
Patients With Epilepsy

Choosing optimal anti-seizure medication (ASM) is very important in pediatric patients with epilepsy who attend school, especially children with an intellectual disability (ID). Levetiracetam (LEV) has proven to be an effective, safe, generally well-tolerated, broad-spectrum ASM in children. In the context of increasing use of LEV in school-aged children with epilepsy and ID, we evaluate relevant clinical data, including efficacy, safety, and tolerability in children with epilepsy and an intellectual disability (ID) or normal intelligence (NI). We performed a retrospective chart review of children and included 298 pediatric patients with epilepsy who were treated with LEV with NI (147) and ID (151). After 6 months, 96% of NI and 83% of ID subjects had a seizure reduction rate greater than 50% (p = 0.031). The tolerability of LEV was generally good, with 75% retention rates at 2 years in both groups and only minor side effects (under 15%). The retention rates of patients with NI and ID were 76% and 74%, respectively (p = 0.597). Thus, LEV showed considerable efficacy with minimal side effects and high retention rates and is an easily maintained and safe treatment option for pediatric epilepsy with ID. However, better-designed research studies are needed to clearly elucidate the efficacy and safety of LEV in children with epilepsy and ID.

scholarly journals PROVE: retrospective, non‐interventional, Phase IV study of perampanel in real‐world clinical care of patients with epilepsy

2021 ◽  
Author(s):  
Robert T. Wechsler ◽  
James Wheless ◽  
Muhammad Zafar ◽  
Graham R. Huesmann ◽  
Marcelo Lancman ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Care ◽  
Patients With Epilepsy ◽  
Phase Iv

Effectiveness of Levetiracetam Monotherapy in Pediatric Patients With Epilepsy

2019 ◽  
Vol 34 (10) ◽  
pp. 593-597 ◽  
Author(s):  
Rafal D. Mazur ◽  
Qianyu Wang, BA ◽  
Kenneth Kato, BS ◽  
Richard Buchsbaum, BS ◽  
Jennifer Bonito, BS ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Prospective Studies ◽  
Pediatric Patients ◽  
Retention Rate ◽  
Retention Rates ◽  
Seizure Freedom ◽  
Entire Cohort ◽  
Number Of Patients ◽  
Patients With Epilepsy

The main objective of this study was to assess the efficacy, safety, and retention rates of levetiracetam monotherapy in children with epilepsy. A retrospective review of pediatric patients receiving levetiracetam monotherapy at 2 large tertiary epilepsy centers over an 11-year period was conducted. One hundred two patients using levetiracetam monotherapy with a mean age of 13.1 years were identified. For the entire cohort, a 6-month retention rate was 61.1% and a 12-month retention rate 53.1%. With regard to seizure freedom, 46.8% of those patients that remained on monotherapy for at least 6 months became seizure free. Twelve-month seizure freedom was reached by 41.2%. About one-third (32.4%) of patients reported adverse effects, with irritability, moodiness, and depression being the most common. Despite a number of patients that reported adverse events, levetiracetam monotherapy was found to be potentially effective in this cohort of children with epilepsy and warrants further, prospective studies.

Treatment of painful bone metastases in prostate and breast cancer patients with the therapeutic radiopharmaceutical rhenium-188-HEDP

2016 ◽  
Vol 55 (05) ◽  
pp. 188-195 ◽  
Author(s):  
Floor Overbeek ◽  
John de Klerk ◽  
Pieternel Pasker-de Jong ◽  
Alexandra van den Berk ◽  
Rob ter Heine ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Clinical Benefit ◽  
Response Rate ◽  
Clinical Care ◽  
Pain Response ◽  
Pain Palliation ◽  
Breast Cancer Patients ◽  
Routine Clinical Care ◽  
Painful Bone Metastases

Summary Aim: Rhenium-188-HEDP (188Re-HEDP) is an effective radiopharmaceutical for the palliative treatment of osteoblastic bone metastases. However, only limited data on its routine use are available and its effect on quality of life (QoL) has not been studied. Therefore, we evaluated the clinical benefit of 188Re-HEDP in routine clinical care. Patients and methods: Prostate or breast cancer patients with painful bone metastases receiving 188Re-HEDP as a routine clinical procedure were eligible for evaluation. Clinical benefit was assessed in terms of efficacy and toxicity. Pain palliation and QoL were monitored using the visual analogue scale (VAS), corrected for opioid intake, and the EORTC QLQ-C30 Global health status/QoL-scale. Thrombocyte and leukocyte nadirs were used to assess haematological toxicity. Results: 45 and 47 patients were evaluable for pain palliation and QoL, respectively. After a single injection of 188Re-HEDP, the overall pain response rate was 69% and mean VAS-scores decreased relevantly and significantly (p < 0.05). Repeated treatment resulted in similar pain response. The overall QoL response rate was 68% and mean Global health status/QoL-scores increased relevantly and significantly. Haematological side effects were mild and transient. Conclusion: The clinically relevant response on pain and quality of life and the limited adverse events prove clinical benefit of treatment with 188Re-HEDP and support its use in routine clinical care. Its effectiveness appears comparable to that of external beam radiotherapy.

Interpersonal Psychotherapy for the Treatment of Eating Disorders

2010 ◽  
pp. 347-372 ◽  
Author(s):  
Marian Tanofsky-Kraff ◽  
Denise E. Wilfley
Keyword(s):  
Anorexia Nervosa ◽  
Clinical Care ◽  
Interpersonal Psychotherapy ◽  
Future Research ◽  
Cognitive Behavior ◽  
Research Directions ◽  
Routine Clinical Care ◽  
Interpersonal Factors ◽  
Future Research Directions

Interpersonal psychotherapy (IPT) is a focused, time-limited treatment that targets interpersonal problem(s) associated with the onset and/or maintenance of EDs. IPT is supported by substantial empirical evidence documenting the role of interpersonal factors in the onset and maintenance of EDs. IPT is a viable alternative to cognitive behavior therapy for the treatment of bulimia nervosa and binge eating disorder. The effectiveness of IPT for the treatment of anorexia nervosa requires further investigation. The utility of IPT for the prevention of obesity is currently being explored. Future research directions include enhancing the delivery of IPT for EDs, increasing the availability of IPT in routine clinical care settings, exploring IPT adolescent and parent–child adaptations, and developing IPT for the prevention of eating and weight-related problems that may promote full-syndrome EDs or obesity.

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