UNASSIGNED: Perampanel is approved for the adjunctive treatment of focal-onset seizures (FOS) with or without secondary generalized seizures. The FAME (Fycompa® as first Add-on to Monotherapy in patients with Epilepsy; NCT02726074) study evaluated the efficacy and safety of perampanel added to monotherapy in patients with FOS with or without secondary generalized seizures (SGS). Post hoc analyses of the FAME study assessed potential predictors of response and an in-depth evaluation of the safety and efficacy of perampanel.
UNASSIGNED: Efficacy was assessed by reduction of total seizure frequency by ≥50%, ≥75% or 100%, and safety by incidence of treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation. Univariate and multivariate logistic regression analyses for treatment response were performed.
UNASSIGNED: Most patients (82/85) received perampanel doses of 4-8 mg/day during maintenance therapy and the highest efficacy rates were achieved with 4 mg/day, irrespective of efficacy outcome. Doses of 4 or 6 mg/day in patients with FOS with SGS (n=16) produced comparable efficacy outcomes. In multivariate analysis, total perampanel dose was predictive of 50% and 75% response rates; longer total perampanel administration period with 50% response; and concomitant non-anti-seizure medication with a 100% response. Patients developed a TEAE more frequently during the 12-week titration period (60.2%) than the 24-week maintenance period (28.4%), including dizziness (45.5% vs. 9.1%), somnolence (10.2% vs. 0%), and headache (4.5% vs. 3.4%).
UNASSIGNED: Post hoc analyses show that even low doses of perampanel may be effective and TEAEs are usually self-limited or well-tolerated.

UNASSIGNED: FAME (Fycompa® as first Add-on to Monotherapy in patients with Epilepsy; NCT02726074), a previously reported single-arm, phase IV study, showed that perampanel improved seizure control as first add-on to failed anti-seizure medication (ASM) monotherapy in 85 South Korean patients aged ≥12 years with focal-onset seizures (FOS) with/without focal to bilateral tonic-clonic seizures. We present results of three post hoc analyses of FAME that further assessed the efficacy and safety of perampanel.
UNASSIGNED: Patients were stratified by low- (4, 6 mg/day) versus high- (8, 10, 12 mg/day) dose maintenance perampanel, perampanel added to first- versus second-line ASM monotherapy, and concomitant background ASM monotherapy and perampanel dose. The primary endpoint was the proportion of patients with a ≥50% reduction in total seizure frequency during the 24-week maintenance period. Safety was assessed by the descriptive incidence of treatment-emergent adverse events (TEAEs).
UNASSIGNED: In post hoc analyses, 50% responder rates were significantly higher for low- versus high-dose maintenance perampanel (88.6% vs. 40.0%; p<0.001) and when added to first- versus second-line ASM monotherapy (83.5% vs. 33.3%; p=0.013). By concomitant background ASM and perampanel maintenance dose, 50% responder rates were 100% for perampanel 4 mg/day added to carbamazepine, oxcarbazepine, lamotrigine, or valproic acid, and 85% when added to levetiracetam. Add-on perampanel improved 75% and seizure-free responder rates, and median percent changes from baseline seizure frequency per 28 days. Perampanel was well tolerated when added to ASM monotherapy, with dizziness being the most common TEAE.
UNASSIGNED: Post hoc analyses of FAME provide supportive data for the use of perampanel as an effective and well-tolerated first add-on treatment to a broad spectrum of ASM monotherapies in patients with FOS.

Objectives: The effect of stimulants on anxiety domains has not been systematically studied. We assessed prospectively the impact of stimulant treatment in children with attention-deficit/hyperactivity disorder (ADHD) on the severity of anxiety domains and on ADHD with comorbid anxiety disorders. Methods: Children with ADHD (n = 57, aged 6-15 years) started a stimulant or were switched from one stimulant to another. Assessments were conducted at four time points (baseline and weeks 2, 6, and 12) and consisted of parental questionnaires (ADHD rating scale, screen for child anxiety related disorders [SCARED]), and side effect questionnaire completed by a child psychiatrist. Results: A significant improvement in total SCARED scores was obtained after 12 weeks stimulant treatment in children both with and without anxiety disorders. Significant reductions were detected in generalized anxiety, separation anxiety, and school avoidance SCARED subscales, but not in panic and social anxiety subscales. ADHD symptoms significantly improved both in children with and without anxiety comorbidities. Conclusion: We found specific effects of stimulants on anxiety domains. Stimulant treatment, even for ADHD children diagnosed with comorbid anxiety disorders, is relatively safe regarding the risk of anxiety exacerbation. Moreover, the presence of anxiety symptoms or disorders does not interfere with the beneficial effect of the stimulants on the ADHD core symptoms. Clinical trial regestration number: IRB SMC-6893-20.

BACKGROUND: Oxidative damage to melanocytes, resulting from an imbalance between the damaging oxidative pathways and the protective anti-oxidants likely plays a pathogenic role in vitiligo.
OBJECTIVE: To evaluate three parameters related to the oxidative stress (OS) pathway namely malondialdehyde (MDA), a marker of oxidative damage, and superoxide dismutase (SOD) and reduced glutathione (rGSH) (both antioxidants) in patients with active and stable vitiligo with either localized or generalized disease.
METHODS: Sixty clinically diagnosed vitiligo patients were categorized into generalized (n = 30) or localized vitiligo (n = 30) and were further sub-grouped according to their disease activity into active and stable groups. Thirty healthy volunteers were included in the control group. ELISA was used for the evaluation of MDA, SOD, and r GSH.
RESULTS: The patient group demonstrated significantly raised levels of MDA and significantly decreased levels of SOD and rGSH compared with the control group. Further, the OS parameters were significantly more deranged in patients with generalized disease (all three-MDA, rGSH, and SOD) and an active disease (MDA) as compared to those with localized and stable disease, respectively.
CONCLUSIONS: Our findings suggest an important role of OS in relation to vitiligo activity and severity. Although the OS parameters were deranged in all subsets of patients, with respect to controls, the derangement of oxidative damage marker (MDA) in generalized and active disease groups was most marked. Disease remains active when the oxidative damage becomes higher but is unmatched with the anti-oxidant reserve which does not proportionately increase.

OBJECTIVE: Definition of the type of appendicitis is based on examination of the peritoneum and appendix. Gomes et al. proposed a laparoscopic grading system of acute appendicitis (grades 1 and 2, noncomplicated appendicitis, grade 3-5 complicated appendicitis). The aim of this study was to evaluate the reproducibility of this score.
METHODS: All patients managed for acute appendicitis between January 2016 and June 2016 were included in this single-center prospective study. Laparoscopic appendectomy procedures were filmed by analogy to Sugerbaker\'s peritoneal carcinomatosis score (9 quadrants, all of the abdomen was filmed). The videos were then analyzed by seven staff surgeons blinded to each other and the operative report. The primary endpoint was to determine the concordance between staff surgeons for grading of appendicitis using the laparoscopic grading system of acute appendicitis described by Gomes et al.
RESULTS: A total of 40 patients were included in this study. A concordance was observed between the seven staff surgeons in 85% of cases. For regional peritonitis, the mean ± (SD) number of quadrants in which the staff surgeons reported signs of peritonitis was 1.44 ± 0.63. For diffuse peritonitis, the mean (SD) number of quadrants in which the staff surgeons reported signs of peritonitis was 2.59 ± 0.51. On ROC curve analysis, two quadrants was the best cut-off between grade 4B (local peritonitis) and five (diffuse peritonitis) acute appendicitis (AUC = 0.92, Se = 100%, Sp = 92%, p = 0.005).
CONCLUSIONS: The classification used to determine the type of appendicitis is reproducible.
CONCLUSIONS: To give a definition of complicated appendicitis.
UNASSIGNED: Mariage M, Sabbagh C, et al. Surgeon\'s Definition of Complicated Appendicitis: A Prospective Video Survey Study. Euroasian J Hepatogastroenterol 2019;9(1):1-4.

OBJECTIVE: To investigate the prevalence of comorbidities among female patients with generalized osteoarthritis (GOA) in comparison to an age- and sex matched control group. To identify clusters of comorbidities in both groups.
METHODS: An observational, cross-sectional study was conducted. Consecutive female patients with hand and knee osteoarthritis according to the American College of Rheumatology (ACR) classification criteria were invited to participate in the study. A control group of participants without musculoskeletal symptoms, history or evidence of osteoarthritis or inflammatory rheumatic disease were also included. Cardiovascular, obstructive pulmonary, gastrointestinal, endocrine, neurological, malignant diseases and depression were recorded in both groups. In both study groups comorbidity cluster and factor analysis was performed.
RESULTS: The study population included 200 GOA and 200 control participants. The following comorbidities were observed adjusted to Bonferroni correction with a significantly higher prevalence among individuals with GOA: hypertension, uterine leiomyoma, gastroesophageal reflux disease, diverticulosis, upper gastrointestinal tract ulcers, depression, diseases with vertigo (benign paroxysmal positional vertigo and vertebrobasilar insufficiency) and surgery due to otoclerosis. In the GOA group 5 clusters were identified with different comorbidity patterns.
CONCLUSIONS: We report a high comorbidity rate in GOA. Cluster analysis allowed us to identify different comorbidity subsets for vascular, gastrointestinal and malignant gynaecological disorders. Further research is required to understand the links between GOA and non-musculoskeletal comorbidities.

Little is known about differences in mental health comorbidity and quality of life in individuals with social anxiety disorder (SAD) according to the number and the types of feared situations.
Using a US nationally representative sample, the National Epidemiologic Survey on Alcohol and Related Conditions, we performed latent class analysis to compare the prevalence rates of mental disorders and quality of life measures across classes defined by the number and the types of feared social situations among individuals with SAD.
Among the 2,448 participants with a lifetime diagnosis of SAD, we identified three classes of individuals who feared most social situations but differed in the number of feared social situations (generalized severe [N = 378], generalized moderate [N = 1,049] and generalized low [N = 443]) and a class of subjects who feared only performance situations [N = 578]. The magnitude of associations between each class and a wide range of mental disorders and quality of life measures were consistent with a continuum model, supporting that the deleterious effects of SAD on mental health may increase with the number of social situations feared. However, we found that individuals with the \"performance only\" specifier may constitute an exception to this model because these participants had significantly better mental health than other participants with SAD.
Our findings give additional support to the recent changes made in the DSM-5, including the introduction of the \"performance only\" specifier and the removal of the \"generalized\" specifier to promote the dimensional approach of the number of social fears.