scholarly journals Relation of Perceived Stigma to Adverse Events of Medications in Patients with Epilepsy

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Ekaterina Viteva

Purpose. We aimed to assess the influence of adverse events (AEs) of antiepileptic drugs (AEDs) on perceived stigma of Bulgarian patients with epilepsy. Methods. Our study was based on questionnaires (Liverpool Adverse Events Profile (LAEP) and stigma scale), information from medical documentation, and an interview on clinical factors of 153 consecutive patients with epilepsy. Results. Perceived stigma was observed in 64.71% of the study participants. There was a significant association between perceived stigma and the total LAEP score (p<0.05, F=13.71). Patients who reported AEs had an increased risk of perceiving stigma compared to those who did not experience AEs. A significant correlation between perceived stigma and the presence of neurological and psychiatric AEs (p<0.001, r=+0.60) and a mild correlation between perceived stigma and the presence of nonneurological AEs (p<0.01, r=+0.20) were verified. In a multivariate regression analysis the only predictors of perceived stigma were AED polytherapy and the presence of neurological and psychiatric AEs. Conclusions. AEs of AEDs in patients with epilepsy significantly correlate with perceived stigma. Our study results will be useful in the campaign to overcome stigma predictors.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S785-S786
Author(s):  
Robert Tipping ◽  
Jiejun Du ◽  
Maria C Losada ◽  
Michelle L Brown ◽  
Katherine Young ◽  
...  

Abstract Background In the RESTORE-IMI 2 trial, imipenem/cilastatin/relebactam (IMI/REL) was non-inferior to PIP/TAZ for treating hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP) in the primary endpoint of Day 28 all-cause mortality (D28 ACM) and the key secondary endpoint of clinical response (CR) at early follow-up (EFU; 7-14 d after end of therapy). We performed a multivariate regression analysis to determine independent predictors of treatment outcomes in this trial. Methods Randomized, controlled, double-blind, phase 3, non-inferiority trial comparing IMI/REL 500 mg/250 mg vs PIP/TAZ 4 g/500 mg, every 6 h for 7-14 d, in adult patients (pts) with HABP/VABP. Stepwise-selection logistic regression modeling was used to determine independent predictors of D28 ACM and favorable CR at EFU, in the MITT population (randomized pts with ≥1 dose of study drug, except pts with only gram-positive cocci at baseline). Baseline variables (n=19) were pre-selected as candidates for inclusion (Table 1), based on clinical relevance. Variables were added to the model if significant (p &lt; 0.05) and removed if their significance was reduced (p &gt; 0.1) by addition of other variables. Results Baseline variables that met criteria for significant independent predictors of D28 ACM and CR at EFU in the final selected regression model are in Fig 1 and Fig 2, respectively. As expected, APACHE II score, renal impairment, elderly age, and mechanical ventilation were significant predictors for both outcomes. Bacteremia and P. aeruginosa as a causative pathogen were predictors of unfavorable CR, but not of D28 ACM. Geographic region and the hospital service unit a patient was admitted to were found to be significant predictors, likely explained by their collinearity with other variables. Treatment allocation (IMI/REL vs PIP/TAZ) was not a significant predictor for ACM or CR; this was not unexpected, since the trial showed non-inferiority of the two HABP/VABP therapies. No interactions between the significant predictors and treatment arm were observed. Conclusion This analysis validated known predictors for mortality and clinical outcomes in pts with HABP/VABP and supports the main study results by showing no interactions between predictors and treatment arm. Table 1. Candidate baseline variables pre-selected for inclusion Figure 1. Independent predictors of greater Day 28 all-cause mortality (MITT population; N=531) Figure 2. Independent predictors of favorable clinical response at EFU (MITT population; N=531) Disclosures Robert Tipping, MS, Merck & Co., Inc. (Employee, Shareholder) Jiejun Du, PhD, Merck & Co., Inc. (Employee, Shareholder) Maria C. Losada, BA, Merck & Co., Inc. (Employee, Shareholder) Michelle L. Brown, BS, Merck & Co., Inc. (Employee, Shareholder) Katherine Young, MS, Merck & Co., Inc. (Employee, Shareholder)Merck & Co., Inc. (Employee, Shareholder) Joan R. Butterton, MD, Merck & Co., Inc. (Employee, Shareholder) Amanda Paschke, MD MSCE, Merck & Co., Inc. (Employee, Shareholder) Luke F. Chen, MBBS MPH MBA FRACP FSHEA FIDSA, Merck & Co., Inc. (Employee, Shareholder)Merck & Co., Inc. (Employee, Shareholder)



10.2196/26161 ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. e26161
Author(s):  
Tom E Biersteker ◽  
Martin J Schalij ◽  
Roderick W Treskes

Background Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health (mHealth) devices, such as single-lead electrocardiogram (ECG) devices, have been introduced to the worldwide consumer market over the past decade. Recent studies have assessed the usability of these devices for detection of AF, but it remains unclear if the use of mHealth devices leads to a higher AF detection rate. Objective The goal of the research was to conduct a systematic review of the diagnostic detection rate of AF by mHealth devices compared with traditional outpatient follow-up. Study participants were aged 16 years or older and had an increased risk for an arrhythmia and an indication for ECG follow-up—for instance, after catheter ablation or presentation to the emergency department with palpitations or (near) syncope. The intervention was the use of an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, either a handheld electronic device or a patch-like device worn on the patient’s chest. Control was standard (traditional) outpatient care, defined as follow-up via general practitioner or regular outpatient clinic visits with a standard 12-lead ECG or Holter monitoring. The main outcome measures were the odds ratio (OR) of AF detection rates. Methods Two reviewers screened the search results, extracted data, and performed a risk of bias assessment. A heterogeneity analysis was performed, forest plot made to summarize the results of the individual studies, and albatross plot made to allow the P values to be interpreted in the context of the study sample size. Results A total of 3384 articles were identified after a database search, and 14 studies with a 4617 study participants were selected. All studies but one showed a higher AF detection rate in the mHealth group compared with the control group (OR 1.00-35.71), with all RCTs showing statistically significant increases of AF detection (OR 1.54-19.16). Statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I2 of 61.9, and therefore it was decided to not pool the results into a meta-analysis. Conclusions Although the results of 13 of 14 studies support the effectiveness of mHealth interventions compared with standard care, study results could not be pooled due to considerable clinical and statistical heterogeneity. However, smartphone-connectable ECG devices provide patients with the ability to document a rhythm disturbance more easily than with standard care, which may increase empowerment and engagement with regard to their illness. Clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF must be deemed significant.



2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14586-e14586 ◽  
Author(s):  
Adam Diehl ◽  
Mark Yarchoan ◽  
Ting Yang ◽  
Blake Scott ◽  
Burles Avner Johnson ◽  
...  

e14586 Background: Inhibition of the PD-1 checkpoint can cause immune activation in non-target tissues, resulting in immune-related adverse events (irAE) in up to 50% of patients. Biomarkers that are associated with irAEs in patients treated with PD-1 inhibitors may have implications for patient selection and clinical management. Methods: We performed an IRB-approved retrospective chart review of adult solid tumor patients treated with nivolumab or pembrolizumab at a single institution from January 2015 until November 2016. Patients were excluded if concurrently receiving investigational therapies, or on unreported clinical trials. Data were collected on treatment history, leukocyte counts, and irAE, defined as adverse events with a potential immunologic basis with grading performed using CTCAE v.4.0. Results: 172 patients were included (lung n = 54; melanoma n = 61; kidney n = 25; esophageal n = 12; bladder n = 8; other tumors n = 12) with median age 67. 18% were treated with concurrent ipilimumab. 31% experienced an adverse event of any grade with a mean time to develop an irAE of 3.5 months. Of those with an irAE, 85% required treatment, 68% were grade ≥ 2, 32% were grade 3 or 4 and 35% required therapy discontinuation due to the irAE. In univariate analysis, a higher ALC at both the start of therapy and at 1 month was associated with increased risk of an irAE of grade ≥ 2 (p < 0.05). A higher absolute lymphocyte count (ALC) or higher absolute eosinophil count (AEC) at 1 month into therapy was associated with increased risk of all irAE (p < 0.05) as well as irAE requiring treatment (p < 0.05). In addition, in a multivariate regression analysis including age, race, tumor type, prior chemotherapy, prior radiation, and concurrent ipilimumab therapy, an ALC > 2000 at the start of therapy was a significant predictor of irAE of grade ≥ 2 (p < 0.05 and OR 2.0), as was an ALC > 2000 at 1 month into therapy (p < 0.05 and OR 1.86). Conclusions: These results suggest that high lymphocyte and eosinophil counts early in the course of anti-PD1 therapy may be associated with a higher risk for clinically significant irAE.



2017 ◽  
Author(s):  
Jesus F Bermejo-Martin ◽  
Catia Cilloniz ◽  
Raul Mendez ◽  
Raquel Almansa ◽  
Albert Gabarrus ◽  
...  

AbstractBackgroundThe role of neutrophil and lymphocyte counts as predictors of prognosis in Community Acquired Pneumonia (CAP) has not been appropriately studied.MethodsThis was a retrospective study to evaluate by multivariate regression analysis, the association between neutrophil and lymphocyte counts with mortality at 30-days post discharge in two large cohorts of hospitalized patients with CAP and no prior immunosupression: a multicentric with 1550 patients recruited at 14 hospitals in Spain and a unicentric with 2840 patients recruited at the Hospital Clinic-Barcelona.FindingsThe unicentric cohort accounted with a higher proportion of critically ill patients: 586 (20·6%) vs 131 (8·5%) and non survivors 245 (8·6%) vs 74 (4·8%). Lymphopenia (< 1000 lymphocytes/mm3) was present in the 52·8% of the patients in both cohorts. A sub-group of lymphopenic patients, those with lymphocyte counts below decil 3 (677 lymphocytes/mm3 in the multicentric cohort and 651 lymphocytes/mm3 in the unicentric one), showed > 2-fold increase in the risk of mortality, independently of the CURB-65 score, critical illness and receiving an appropriated antibiotic treatment: (OR [CI95%], p) (2·18 [1·21- 3·92], 0·009) and (2·33 [1·61-3·33], <0·001) respectively. Neutrophil counts were not associated with mortality risk.InterpretationLymphopenia is present in a half of the patients with CAP needing of hospitalization, in absence of antecendents of immunosupression. Lymphopenic CAP with lymphocyte counts < 664 lymphocytes/mm3 constitutes a particular immunological phenotype of the disease which is associated to an increased risk of mortality.FundingCibeRes, 2009 Support to Research Groups of Catalonia 911, IDIBAPS, SEPAR, SVN



2020 ◽  
Author(s):  
Kenichiro Sato ◽  
Tatsuo Mano ◽  
Atsushi Iwata ◽  
Tatsushi Toda

AbstractObjectivesAs of the early April 2020, the antimalarial drug, chloroquine, has been approved as an emergency treatment for the coronavirus disease 2019 (COVID-19) in the United States and in Europe. Although infrequent, neuropsychiatric symptoms have been reported in patients who received chloroquine for the treatment of malaria or autoimmune diseases. In this study, we investigated these adverse events (AEs) using a large self-reporting database.Materials and MethodsWe conducted a disproportionality analysis for the detection of neuropsychiatric AE signals associated with the use of chloroquine (or hydroxychloroquine), reported to FAERS database between the fourth quarter of 2012 and the fourth quarter of 2019. Adjusted reporting odds ratio (ROR) for the development of each of the neuropsychiatric AEs following the use of chloroquine was calculated using a multilevel model.ResultsWe included 2,389,474 AE cases, among which 520 cases developed neuropsychiatric AE following the use of chloroquine. Exposure to chloroquine was associated with a statistically significant high reporting of amnesia, delirium, hallucinations, depression, and loss of consciousness, (lower 95% confidence interval of the adjusted ROR > 1), although the degree of increase in their ROR was limited. There was no statistically significant high reporting of any other neuropsychiatric AE, including suicide, psychosis, confusion, and agitation.ConclusionCurrent pharmacovigilance study results did not suggest any potential link between the use of chloroquine and an increased risk of suicide, psychosis, confusion, and agitation, which would be informative during the emergency use of chloroquine for the treatment of COVID-19.



Author(s):  
Sedat Taştemur ◽  
Senol Tonyali ◽  
Bugra Bilge Keseroglu ◽  
Mercan Tastemur ◽  
Mustafa Karaaslan ◽  
...  

ABSTRACT Objective: In this study we aimed to determine the coexistence of overactive bladder in patients with gastroenterological disorders including hepatitis, cirrhosis and IBD. Materials and Methods: we prospectively collected the data of patients who admitted to the outpatient clinic of department of gastroenterology at xxx hospital between May 2017 and February 2019. All patients with chronic gastroenterological disorders such as hepatitis and irritable bowel syndrome willing to participate the study after the verbal consent were included the study Results: A total of 289 female patients were included the study. The mean age of the patients was 49.9 ±13 years. The mean BMI value was 27.9± 4.5 kg/m2. Among 289 patients, 135 (46.7%) had Hepatitis B, 53 (18.3%) had ulcerative colitis, 35 (12.1%) had Crohn’s disease, 22 (7.6%) had autoimmune hepatitis, 19 (6.6%) had primer biliary cirrhosis, 13 (4.5%) had Hepatitis C and 12(4.2%) had celiac disease. The mean age of patients was similar between patients having OAB-v8 higher and lower than 8 (p=0.46). However, patients having OAB score>8 had higher BMI compared to patients who had OAB score <8, 29.1 ±5 vs. 27.2 ±4.1 kg/m2, p=0.001. In multivariate regression analysis, BMI was the sole indicator of OAB (p=0.001) whereas age (p=0.46), menopause status (p=0.33), smoking status (p=0.97) were not. Conclusion: The incidence of OAB in our patient cohort was higher than the reported incidence which might suggest evaluation patients with gastrointestinal disorders in terms of overactive bladder on routine follow-up.



2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Yeonghee Eun ◽  
In Young Kim ◽  
Jong-Mu Sun ◽  
Jeeyun Lee ◽  
Hoon-Suk Cha ◽  
...  

Abstract We investigated risk factors for immune-related adverse events (irAEs) in patients treated with anti-programmed cell death protein1 antibody pembrolizumab. A retrospective medical record review was performed to identify all patients who received at least one dose of pembrolizumab at Samsung Medical Center, Seoul, Korea between June 2015 and December 2017. Three hundred and ninety-one patients were included in the study. Data were collected on baseline characteristics, treatment details, and adverse events. Univariate and multivariate logistic regression models were used to identify risk factors for irAEs. Sixty-seven (17.1%) patients experienced clinically significant irAEs; most commonly dermatologic disorders, followed by pneumonitis, musculoskeletal disorders, and endocrine disorders. Fourteen patients (3.6%) experienced serious irAEs (grade ≥ 3). Most common serious irAEs were pneumonitis (2.3%). Four deaths were associated with irAEs, all of which were due to pneumonitis. In multivariate regression analysis, a higher body mass index (BMI) and multiple cycles of pembrolizumab were associated with higher risk of irAEs (BMI: odds ratio [OR] 1.08, 95% confidence interval [CI] 1.01–1.16; pembrolizumab cycle: OR 1.15, 95% CI 1.08–1.22). A derived neutrophil-lymphocyte ratio (dNLR) greater than 3 at baseline was correlated with low risk of irAEs (OR 0.37, 95% CI 0.17–0.81). Our study demonstrated that an elevated BMI and higher number of cycles of pembrolizumab were associated with an increased risk of irAEs in patients treated with pembrolizumab. Additionally, increased dNLR at baseline was negatively correlated with the risk of developing irAEs.



2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Eman M. Hasan ◽  
Rasha A. Abd Al Aziz ◽  
Dina Sabry ◽  
Hedy A. Badary ◽  
Yasmine Gaber ◽  
...  

Abstract Background Several genetic polymorphisms have been proven to play a key role in the progression of non-alcoholic fatty liver disease (NAFLD) from simple steatosis to NASH with fibrosis. Our aim was to study the effect of single nucleotide polymorphisms (SNPs) in the adiponectin gene, namely rs266729 and rs3774261, on susceptibility to NAFLD and disease progression. Results There was a definitive association between polymorphisms of the studied SNPs and NAFLD. Among rs266729, CG was significantly higher among patients than controls showing increased risk for NAFLD (P<0.05). AA genotype of the rs3774261 variant was significantly lower in patients than in controls (P value< 0.001) while AG and GG genotypes were significantly higher in patients than in controls (P value<0.05); A allele was significantly higher among controls (P=0.019) which might have a protective effect. None of the variants correlated significantly with the degree of steatosis. Using multivariate regression analysis, there was no significant correlation with any of the independent risk factors to the degree of steatosis. Conclusions There was an association between polymorphisms of the studied SNPs of rs266729 and rs3774261 of the adiponectin gene and NAFLD.



Hypertension ◽  
2020 ◽  
Vol 75 (4) ◽  
pp. 1025-1033 ◽  
Author(s):  
Jacopo Burrello ◽  
Silvia Monticone ◽  
Isabel Losano ◽  
Giovanni Cavaglià ◽  
Fabrizio Buffolo ◽  
...  

Primary aldosteronism (PA) was considered a rare disorder almost always associated with hypokalemia. The widespread screening of patients with hypertension unveiled an increased prevalence of PA with normokalemic hypertension the prevailing phenotype. Many studies have reported the prevalence of hypokalemia in patients with PA; conversely, the prevalence of PA in patients with hypokalemia is unknown. In this retrospective observational study, we define the prevalence of hypokalemia in referred patients with hypertension and the prevalence of PA in patients with hypokalemia and hypertension. Hypokalemia was present in 15.8% of 5100 patients with hypertension, whereas 76.9% were normokalemic, and 7.3% hyperkalemic. The prevalence of PA in patients with hypokalemia was 28.1% and increased with decreasing potassium concentrations up to 88.5% of patients with spontaneous hypokalemia and potassium concentrations <2.5 mmol/L. A multivariate regression analysis demonstrated the association of hypokalemia with the occurrence of cardiovascular events independent of PA diagnosis. An association of PA with the occurrence of cardiovascular events and target organ damage independent of hypokalemia was also demonstrated. In conclusion, our results confirm that PA is a frequent cause of secondary hypertension in patients with hypokalemia, and the presence of hypertension and spontaneous hypokalemia are strong indications for PA diagnosis. Finally, we show that PA and hypokalemia are associated with an increased risk of cardiovascular events.



2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Yeon-Ji Kim ◽  
Dae Bum Kim ◽  
Woo Chul Chung ◽  
Ji Min Lee

Background. The aim of this study was to evaluate the risk of development of colorectal adenomas in patients with colorectal cancer (CRC) with and without colonic diverticulosis. Methods. We performed a retrospective cohort study that included patients with CRC between 2008 and 2011. All patients underwent preoperative colonoscopic and barium enema examinations. Follow-up colonoscopic examinations were performed within 1 year and between 3 and 5 years postoperatively. The incidence of colorectal adenomas was compared based on the presence or absence of diverticulosis. Additionally, multivariate logistic regression analysis was performed to identify the factors independently associated with the development of synchronous and metachronous colorectal adenomas. Results. Of the 168 patients with CRC included in the study, 55 showed colonic diverticulosis. Synchronous colorectal adenomas were more common in CRC patients with diverticulosis than in those without diverticulosis (P>0.001). Multivariate regression analysis showed that colonic diverticulosis (odds ratio (OR) 3.874, 95% confidence interval (CI) 1.843–8.144, P>0.001) and obesity (body mass index>25.0 kg/m2, OR 2.395, 95% CI 1.089–5.270, P=0.030) were associated with an increased risk of synchronous colorectal adenomas. The presence of synchronous colorectal adenomas increased the risk of metachronous colorectal adenomas (OR 4.407, 95% CI 1.855–10.473, P>0.001). Conclusions. Colonic diverticulosis was associated with synchronous colorectal adenomas in patients with CRC, which is eventually increasing the risk of metachronous adenomas.



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