Marijuana Use May Be Associated with Reduced Prevalence of Prostate Cancer: A National Survey on Drug Use and Health Study from United States of America.

Preclinical evidence indicates the potential anti-tumor capabilities of cannabinoids in prostate cancer (PC). We undertook a cross-sectional study using National Survey on Drug Use and Health data from 2002 to 2020, involving 2503 participants in the USA. The independent variable was marijuana use status (current, former, never), while the dependent variable was self-reported PC (yes, no). Eleven other demographic variables were assessed as covariates. PC prevalence was lower among current marijuana users (46/145, 31.7%) and former users (323/1021, 31.6%) compared to non-users (534/1337, 39.9%, p < 0.001). PC prevalence was lower among users versus non-users in the elderly (≥65) (36.4% vs. 42.4%, p = 0.016) and non-Hispanic white subgroups (28.9% vs. 38.3%, p < 0.001). There were no significant PC prevalence differences between users and non-users in the younger population (50-64) or other race/ethnicity. In the multivariable analyses, former marijuana use was associated with lower PC compared to never using (odd ratio = 0.74, 95% CI 0.62-0.90, p = 0.001). Current use was also suggestive of reduced prevalence but was not statistically significant (odd ratio = 0.77, 95% CI 0.52-1.14, p = 0.198), possibly due to low sample size. Our findings from a large national survey provide additional data to link marijuana use with lower PC prevalence.

Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.

BACKGROUND: Long-term management options that specifically target the underlying inflammation in eosinophilic oesophagitis are needed. Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13; we aimed to assess its long-term efficacy and safety in adults and adolescents with eosinophilic oesophagitis enrolled in part B of the LIBERTY EoE TREET study who continued to part C (part B-C). METHODS: LIBERTY EoE TREET was a three-part, double-blind, randomised, placebo-controlled, phase 3 study conducted at 65 hospitals and private clinics across ten countries in Australia, Canada, Europe, and the USA. Adults or adolescents (aged ≥12 years) with a diagnosis of eosinophilic oesophagitis by endoscopic biopsy (peak oesophageal intraepithelial eosinophil count ≥15 eosinophils per high-power field [eos/hpf]) from at least one oesophageal region despite 8 weeks of high-dose proton-pump inhibitors (PPIs) and a Dysphagia Symptom Questionnaire (DSQ) score of at least 10 at baseline were eligible. In part B, patients were randomly (1:1:1) assigned to receive subcutaneous dupilumab 300 mg either weekly or every 2 weeks or weekly placebo until week 24. Randomisation was done centrally by interactive voice response system/web response system (IVRS/IWRS) in blocks and stratified according to age (<18 years vs ≥18 years) and use of PPI at randomisation (yes vs no). Patients, study sponsors, and investigators involved in the study were masked to the randomisation outcome. Eligible patients who received placebo in part B and continued to part C were randomly assigned again (1:1) to either weekly dupilumab (placebo/weekly dupilumab group) or dupilumab every 2 weeks (placebo/dupilumab every 2 weeks), with matching placebo alternating with dupilumab doses. Patients who were randomly assigned to one of the dupilumab dose regimens in part B remained on the same regimen in part C for an additional 28 weeks (weekly dupilumab/weekly dupilumab group or dupilumab every 2 weeks/dupilumab every 2 weeks group). Treatment assignment in part C was managed by IVRS/IWRS to maintain blinding of treatment assignment in part B. The primary endpoint of this trial has been reported; here, we report the week 52 outcomes of part B-C. Efficacy and safety analyses were done in the part C safety-analysis set, which included all patients who were randomised in part B, entered part C, and received any study drug in part C. This completed trial is registered with ClinicalTrials.gov, number NCT03633617. FINDINGS: Between Aug 12, 2019, and March 11, 2021, 240 patients were randomly assigned into part B, of whom 227 (74 in placebo group, 74 in weekly dupilumab group, and 79 in dupilumab every 2 weeks group) continued into part B-C and were included in the current analysis. 37 patients switched from placebo to weekly dupilumab, and 37 from placebo to dupilumab every 2 weeks; 74 patients continued on weekly dupilumab and 79 continued on dupilumab every 2 weeks. Of the patients who entered part B-C, 75 (33%) were adolescents, 145 (64%) male, 82 (36%) female, and 206 (91%) White. At week 52, 55 (85%) patients in the weekly dupilumab/weekly dupilumab group, 25 (68%) in the placebo/weekly dupilumab group, 54 (74%) in the every 2 weeks dupilumab/every 2 weeks dupilumab group, and 23 (72%) in the placebo/every 2 weeks dupilumab group achieved a peak oesophageal intraepithelial eosinophil count of 6 eos/hpf or less. Mean percent change from part B baseline in peak eosinophil count was -95·9% (95% CI -96·9 to -94·9) in the weekly dupilumab/weekly dupilumab group, -84·2% (-98·3 to -70·2) in the placebo/weekly dupilumab group, -84·8% (-94·3 to -75·2) in the every 2 weeks dupilumab/every 2 weeks dupilumab group, and -91·2% (-95·9 to -86·5) in the placebo/every 2 weeks dupilumab group at week 52. At week 52, mean change from part B baseline in eosinophilic oesophagitis Histology Scoring System (HSS) grade score was -1·0 point (95% CI -1·1 to -0·9) in the weekly dupilumab/weekly dupilumab group and -0·9 points (-1·0 to -0·8) in the placebo/weekly dupilumab group; mean change in eosinophilic oesophagitis HSS stage score was -0·9 points (-1·0 to -0·8) in the weekly dupilumab/weekly dupilumab group and -0·9 points (-1·0 to -0·8) in the placebo/weekly dupilumab group. Similar improvements were observed in the every 2 weeks dupilumab groups. Mean absolute change from part B baseline in DSQ score was -30·3 points (95% CI -34·5 to -26·1) in the weekly dupilumab/weekly dupilumab group, -27·3 points (-32·1 to -22·4) in the placebo/weekly dupilumab group, -20·9% (-25·4 to -16·3) in the every 2 weeks dupilumab/every 2 weeks dupilumab group, and -23·7% (-29·1 to -18·3) in the placebo/every 2 weeks dupilumab group at week 52. Mean change from part B baseline in endoscopic reference score was -5·4 points (95% CI -6·1 to -4·6) in the weekly dupilumab/weekly dupilumab group, -6·1 points (-7·3 to -4·9) in the placebo/weekly dupilumab group, -5·2% (-6·0 to -4·4) in the every 2 weeks dupilumab/every 2 weeks dupilumab group, and -4·3% (-5·4 to -3·1) in the placebo/every 2 weeks dupilumab group at week 52. During part B-C, one (3%) patient in the placebo/weekly dupilumab group, one (1%) in the weekly dupilumab/weekly dupilumab group, and one (3%) in the placebo/every 2 weeks dupilumab group received rescue medication. One (3%) patient in the placebo/every 2 weeks dupilumab group and one (1%) in the dupilumab every 2 weeks/dupilumab every 2 weeks group underwent a rescue oesophageal dilation procedure. The most common treatment-emergent adverse events were injection-site reactions (ten [14%] in the weekly dupilumab/weekly dupilumab group and four [11%] in the placebo/weekly dupilumab group). INTERPRETATION: Improvements in histological, symptomatic, endoscopic, and molecular features of eosinophilic oesophagitis observed after 24 weeks of weekly dupilumab treatment were maintained or continued to improve to week 52. These findings reinforce the importance of weekly dupilumab, rather than every 2 weeks, for the improvement of symptoms in adults and adolescents with eosinophilic oesophagitis. FUNDING: Sanofi and Regeneron Pharmaceuticals Inc.

Transcriptomic responses in the blood and sputum of cigarette smokers compared to e-cigarette vapers.

RATIONALE: Electronic (e)-cigarettes are popular among youth and cigarette smokers attempting to quit. Studies to date have focused on the utility of e-cigarettes as a smoking cessation tool, but the biological effects are largely unknown. OBJECTIVES: To identify transcriptomic differences in the blood and sputum of e-cigarette users compared to conventional cigarettes smokers and healthy controls and describe biological pathways affected by these tobacco products. METHODS: Cross-sectional analysis of whole blood and sputum RNA-sequencing data from 8 smokers, 9 e-cigarette users (e-cigs) and 4 controls. Weighted gene co-network analysis (WGCNA) identified gene module associations. Ingenuity Pathway Analysis (IPA) identified canonical pathways associated with tobacco products. MAIN RESULTS: In blood, a three-group comparison showed 16 differentially expressed genes (DEGs); pair-wise comparison showed 7 DEGs between e-cigs and controls, 35 DEGs between smokers and controls, and 13 DEGs between smokers and e-cigs. In sputum, 438 DEGs were in the three-group comparison. In pair-wise comparisons, there were 2 DEGs between e-cigs and controls, 270 DEGs between smokers and controls, and 468 DEGs between smokers and e-cigs. Only 2 genes in the smokers vs. control comparison overlapped between blood and sputum. Most gene modules identified through WGCNA associated with tobacco product exposures also were associated with cotinine and exhaled CO levels. IPA showed more canonical pathways altered by conventional cigarette smoking than by e-cigarette use. CONCLUSION: Cigarette smoking and e-cigarette use led to transcriptomic changes in both blood and sputum. However, conventional cigarettes induced much stronger transcriptomic responses in both compartments.

Prospective predictors of electronic nicotine delivery system initiation in tobacco naive young adults: A machine learning approach.

The use of electronic nicotine delivery systems (ENDS) is increasing among young adults. However, there are few studies regarding predictors of ENDS initiation in tobacco-naive young adults. Identifying the risk and protective factors of ENDS initiation that are specific to tobacco-naive young adults will enable the creation of targeted policies and prevention programs. This study used machine learning (ML) to create predictive models, identify risk and protective factors for ENDS initiation for tobacco-naive young adults, and the relationship between these predictors and the prediction of ENDS initiation. We used nationally representative data of tobacco-naive young adults in the U.S drawn from the Population Assessment of Tobacco and Health (PATH) longitudinal cohort survey. Respondents were young adults (18-24 years) who had never used any tobacco products in Wave 4 and who completed Waves 4 and 5 interviews. ML techniques were used to create models and determine predictors at 1-year follow-up from Wave 4 data. Among the 2,746 tobacco-naive young adults at baseline, 309 initiated ENDS use at 1-year follow-up. The top five prospective predictors of ENDS initiation were susceptibility to ENDS, increased days of physical exercise specifically designed to strengthen muscles, frequency of social media use, marijuana use and susceptibility to cigarettes. This study identified previously unreported and emerging predictors of ENDS initiation that warrant further investigation and provided comprehensive information on the predictors of ENDS initiation. Furthermore, this study showed that ML is a promising technique that can aid ENDS monitoring and prevention programs.

Declining Enrolment and Other Challenges in IBD Clinical Trials: Causes and Potential Solutions.

BACKGROUND: Rates of enrolment in clinical trials in inflammatory bowel disease [IBD] have decreased dramatically in recent years. This has led to delays, increased costs and failures to develop novel treatments. AIMS: The aim of this work is to describe the current bottlenecks of IBD clinical trial enrolment and propose solutions. METHODS: A taskforce comprising experienced IBD clinical trialists from academic centres and pharmaceutical companies involved in IBD clinical research predefined the four following levels: [1] study design, [2] investigative centre, [3] physician and [4] patient. At each level, the taskforce collectively explored the reasons for declining enrolment rates and generated an inventory of potential solutions. RESULTS: The main reasons identified included the overall increased demands for trials, the high screen failure rates, particularly in Crohn's disease, partly due to the lack of correlation between clinical and endoscopic activity, and the use of complicated endoscopic scoring systems not reflective of the totality of inflammation. In addition, complex trial protocols with restrictive eligibility criteria, increasing burden of procedures and administrative tasks enhance the need for qualified resources in study coordination. At the physician level, lack of dedicated time and training is crucial. From the patients' perspective, long washout periods from previous medications and protocol requirements not reflecting clinical practice, such as prolonged steroid management and placebo exposures, limit their participation in clinical trials. CONCLUSION: This joint effort is proposed as the basis for profound clinical trial transformation triggered by investigative centres, contract research organizations, sponsors and regulatory agencies.

Variation of Hepatocellular Carcinoma Treatment Patterns and Survival Across Geographic Regions in a Veteran Population.

BACKGROUND: Veteran populations have five times the incidence of hepatocellular carcinoma (HCC) compared with the general population. The incidence of HCC has increased in the Veteran's Affairs Health System (VAHS), primarily due to the increased prevalence of cirrhosis. This study aimed to characterize differences in treatment patterns and overall survival rates across the five VAHS geographic regions. METHODS: Using the VA Corporate Data Warehouse, the authors built a comprehensive national dataset of Veteran patients with HCC diagnosed between 2001 and 2015 to compare patients across VAHS regions. A multivariable Cox proportional hazards model was used to identify factors associated with 5-year all-cause mortality. Kaplan-Meier curves were used to visualize the patient survival function, and the log-rank test was applied to test statistical significance. RESULTS: This retrospective study analyzed 13,434 patients. The West region had the highest rate of overall treatment receipt (63.6%), and the Southwest had the lowest rate (52.9%). After adjustment for demographic, clinicopathologic, treatment, and hospital factors, treatment in a non-West region continued to be significantly associated with a 10% to 13% increased risk of 5-year mortality (Midwest: hazard ratio [HR], 1.11; 95% confidence interval [CI], 1.03-1.17; Northeast: HR, 1.10; 95% CI, 1.03-1.17; Southeast: HR, 1.13; 95% CI, 1.06-1.21; Southwest: HR, 1.11; 95% CI, 1.03-1.19) (p < 0.01). CONCLUSIONS: Treatment patterns and overall survival rates of HCC patients differ significantly across VAHS geographic regions. Targeted interventions to increase the rate of treatment in the non-West regions are needed to improve survival of HCC Veterans and provide uniformly high-quality care across VAHS facilities.

Trends and Disparities in Treatment Utilization for Early-Stage Hepatocellular Carcinoma in the Veteran Population.

BACKGROUND: The incidence of hepatocellular carcinoma (HCC) has substantially increased over the last two decades within the Veteran Affairs Health System (VAHS). This study aims to describe the temporal trend of early-stage HCC (ES-HCC) treatment in the VAHS and identify patient/hospital factors associated with treatment disparities. PATIENTS AND METHODS: VA Corporate Data Warehouse was used to identify patients diagnosed with ES-HCC (stages I/II) from 2001 to 2015. Initial course of therapy was categorized as curative treatment (CT), noncurative treatment (NCT), or no treatment (NT). Univariate logistic regression and stepwise multivariate logistic regression models were used to analyze factors associated with receipt of treatment (CT/NCT) versus NT and receipt of CT versus NCT. RESULTS: Our study included 9504 patients (15% CT, 51% NCT, and 34% NT). During the study period, the rate of overall treatment increased, while the rate of CT decreased (p < 0.001). Stage II, age > 65 years, presence of non-alcoholic fatty liver disease (NAFLD), Child-Pugh C, higher Model for End-Stage Liver Disease (MELD) score, platelets < 100,000/mm3, low hospital complexity score, and Southwest location were significantly associated with higher rates of NT (all p < 0.05). Factors significantly associated with decreased utilization of CT included Hispanic race, lower hospital complexity score, and treatment in the Midwest, West, or Southeast regions (all p < 0.05). CONCLUSIONS: There is a significant trend toward increased overall treatment utilization with decreased use of curative-intent approaches for ES-HCC in the national veteran population, and significant hospital and regional disparities exist. Further characterization and investigation of these factors may facilitate implementation of interventions to improve treatment utilization for the veteran population with HCC.

Bilateral sciatic hernias in an elderly woman successfully managed with robotic surgery: A case report and literature review.

INTRODUCTION: Sciatic hernias are the rarest form of pelvic floor hernias as well as an uncommon cause of sciatica. A high index of suspicion is required to make the diagnosis due to its variable clinical presentation. This is the first case describing bilateral intestinal sciatic hernia, diagnosis, and robotic surgical repair. PRESENTATION OF CASE: A 77-year-old female with history of chronic back pain and diverticulitis presented with three weeks of abdominal pain, radiating down her legs bilaterally. Computed tomography (CT) revealed bilateral sciatic notch hernias without evidence of bowel obstruction. Magnetic resonance imaging (MRI) confirmed compression of the sciatic nerves within the sciatic notch bilaterally. She underwent robotic bilateral retroperitoneal sciatic notch hernia repair successfully. DISCUSSION: There are several independent causes of abdominal pain and bilateral radiating leg pain. Sciatic hernias are an unusual cause of both. Aside from bowel, the hernia can involve other structures, such as the bladder, ureters, or ovaries, potentially creating drastically different clinical pictures. Laparoscopic or robotic repair have been proven superior to open surgery in the literature. CONCLUSION: This case demonstrates that bilateral sciatic hernias can present as uncomplicated sciatica in an elderly patient, but the addition of seemingly unrelated abdominal pain should warrant further investigation. Minimally invasive robotic repair can successfully treat sciatic hernias.

E-Cigarette Use in Young Adult Never Cigarette Smokers with Disabilities: Results from the Behavioral Risk Factor Surveillance System Survey.

Young adult never cigarette smokers with disabilities may be at particular risk for adopting e-cigarettes, but little attention has been paid to these people. This study examines the associations between different types of disability and e-cigarette use in this population. Young adult never-smokers from the 2016-2017 Behavioral Risk Factor Surveillance System (BRFSS) survey who were either never or current e-cigarette users (n = 79,177) were selected for the analysis. The Least Absolute Shrinkage and Selection Operator (LASSO) algorithm was used to select confounders for multivariable logistic regression models. Multivariable logistic regression models were used to determine the associations between current e-cigarette use and different types of disability after incorporating BRFSS survey design and adjusting for confounders. Young adult never-smokers who reported any disability had increased odds (OR 1.44, 95% CI 1.18-1.76) of e-cigarette use compared to those who reported no disability. Young adult never-smokers who reported self-care, cognitive, vision, and independent living disabilities had higher odds of e-cigarette use compared to those who reported no disability. There was no statistically significant difference in the odds of e-cigarette use for those reporting hearing and mobility disabilities compared to those who reported no disability. This study highlights the need for increased public education and cessation programs for this population.

Biomarkers of Toxicant Exposure and Inflammation Among Women of Reproductive Age Who Use Electronic or Conventional Cigarettes.

Background: Electronic cigarettes (e-cigarettes) generally have a more favorable toxicant profile than conventional cigarettes; however, limited information exists for women of reproductive age (WRA). Our aim was to compare biomarkers of toxicant exposure, inflammation, and oxidative stress among WRA who self-report exclusive e-cigarette use, exclusive cigarette smoking, or never tobacco use (controls). Methods: Multivariable linear regression models were used to compare the geometric means of urinary biomarkers of toxicant exposure and their metabolites, serum markers of inflammation [highly sensitive C-reactive protein, soluble intercellular adhesion molecule (sICAM), interleukin 6, fibrinogen], and a measurement of oxidative stress [prostaglandin F2a-8-isoprostane (F2PG2a)] among WRA from the Population Assessment of Tobacco and Health survey. Results: E-cigarette users had higher levels of lead, tobacco-specific nitrosamines, nicotine metabolites, and some volatile organic compounds (VOCs) than controls. Except for cadmium and lead, e-cigarette users had lower levels of the analyzed urinary toxicant biomarkers compared with cigarette smokers. Cigarette smokers had higher levels of all the biomarkers of toxicant exposure than controls. There were no significant differences in the levels of markers of inflammation and oxidative stress between e-cigarette users and controls. E-cigarette users and controls had lower levels of sICAM and F2PG2a than cigarette smokers. Conclusion: WRA who use e-cigarettes had lower levels of some of the evaluated urinary biomarkers of toxicant exposure and serum biomarkers of inflammation and oxidative stress than those who smoke cigarettes, but higher lead, nicotine metabolites, and some VOCs than controls, which can increase health risks.

Electronic Cigarettes Associated With Incident and Polysubstance Use Among Youth.

PURPOSE: Electronic cigarette (e-cigarette) use has increased exponentially among the youth in the United States and may increase the incidence of substance use. METHODS: Youth participants (12-17 years) were surveyed through the Population Assessment of Tobacco and Health study over a three-year time period. Youth with any baseline substance use or diagnosis of an attention deficit disorder were excluded from the analysis. Multivariable logistic regressions were used to assess the association between e-cigarette use at Wave 1 and incident substance use (marijuana, painkillers, sedatives, or tranquilizers and Ritalin/Adderall) and polysubstance use at Wave 2 or 3, and marijuana use in the electronic nicotine device at Wave 3. RESULTS: Baseline ever e-cigarette users who had no history of marijuana, nonprescribed drugs and illicit substance use in Wave 1 had increased odds of reporting incident use of marijuana (odds ratio 2.59, 95% confidence interval: 1.90-3.52), nonprescribed Ritalin/Adderall use (1.89, 1.09-3.28), or polysubstance use (2.09, 1.43-3.05) in Wave 2 or 3 compared to never e-cigarette users. They were also more likely to report use of marijuana in the electronic nicotine product (2.26, 1.56-3.27) in Wave 3 compared to never e-cigarette users. There was no statistically significant association between baseline e-cigarette use and incident use of painkillers, sedatives, or tranquilizers in Wave 2 or 3 (1.21, .79-1.87). CONCLUSIONS: E-cigarette use is associated with incident use of marijuana, marijuana in electronic nicotine devices, Ritalin/Adderall, and polysubstance use but not painkillers, sedatives, or tranquilizers. Results indicate that e-cigarettes are associated with subsequent additional risky health behaviors in youth.

The inflammatory biomarker YKL-40 is elevated in the serum, but not the sputum, of E-cigarette users.

METHODS: We conducted a cross-sectional study of adults between 18 and 55 years old. Inclusion criteria were: exclusive e-cigarette use or cigarette smoking for ≥ 1 year or no history of tobacco use. Participants with a history of pulmonary illness, atopy, medications (except birth control pills), marijuana, and illegal substance use were excluded. Custom Multiplex ELISA was used to measure YKL-40 and other biomarker levels in the serum and induced sputum of the participants. Multivariable linear regression was used to compare the levels of YLK-40 in healthy participants, e-cigarette, and cigarette users after adjusting for age, sex, and BMI. RESULTS: We recruited 20 healthy controls, 23 cigarette smokers, and 22 exclusive e-cigarette users. Serum YKL-40 (ng/ml) was significantly higher in e-cigarette users (Median 21.2 [IQR 12.1-24.0] ng/ml) when compared to controls (12.2 [IQR 8.7-18.1] ng/ml, p = 0.016) but comparable to cigarette smokers (21.6 [IQR 11.62-51.7] ng/ml, p = 0.31). No significant differences were found in the serum or sputum of the other biomarkers tested. CONCLUSION: The inflammatory biomarker, YKL-40 is elevated in the serum but not the sputum of e-cigarette users with no reported pulmonary disease. Further research is necessary to characterize this association.

Factors Associated with E-Cigarette Use in U.S. Young Adult Never Smokers of Conventional Cigarettes: A Machine Learning Approach.

E-cigarette use is increasing among young adult never smokers of conventional cigarettes, but the awareness of the factors associated with e-cigarette use in this population is limited. The goal of this work was to use machine learning (ML) algorithms to determine the factors associated with current e-cigarette use among US young adult never cigarette smokers. Young adult (18-34 years) never cigarette smokers from the 2016 and 2017 Behavioral Risk Factor Surveillance System (BRFSS) who reported current or never e-cigarette use were used for the analysis (n = 79,539). Variables associated with current e-cigarette use were selected by two ML algorithms (Boruta and Least absolute shrinkage and selection operator (LASSO)). Odds ratios were calculated to determine the association between e-cigarette use and the variables selected by the ML algorithms, after adjusting for age, gender and race/ethnicity and incorporating the BRFSS complex design. The prevalence of e-cigarette use varied across states. Factors previously reported in the literature, such as age, race/ethnicity, alcohol use, depression, as well as novel factors associated with e-cigarette use, such as disabilities, obesity, history of diabetes and history of arthritis were identified. These results can be used to generate further hypotheses for research, increase public awareness and help provide targeted e-cigarette education.

Ticagrelor Removal by CytoSorb® in Patients Requiring Emergent or Urgent Cardiac Surgery: A UK-Based Cost-Utility Analysis.

BACKGROUND: Acute coronary syndrome patients receiving dual antiplatelet therapy who need emergent or urgent cardiac surgery are at high risk of major bleeding, which can impair postoperative outcomes. CytoSorb®, a blood purification technology based on adsorbent polymer, has been demonstrated to remove ticagrelor from blood during on-pump cardiac surgery. OBJECTIVE: The aim of this study was to evaluate the cost utility of intraoperative removal of ticagrelor using CytoSorb versus usual care among patients requiring emergent or urgent cardiac surgery in the UK. METHODS: A de novo decision analytic model, based on current treatment pathways, was developed to estimate the short- and long-term costs and outcomes. Results from randomised clinical trials and national standard sources such as National Health Service (NHS) reference costs were used to inform the model. Costs were estimated from the NHS and Personal Social Services perspective. Deterministic and probabilistic sensitivity analyses (PSAs) explored the uncertainty surrounding the input parameters. RESULTS: In emergent cardiac surgery, intraoperative removal of ticagrelor using CytoSorb was less costly (£12,933 vs. £16,874) and more effective (0.06201vs. 0.06091 quality-adjusted life-years) than cardiac surgery without physiologic clearance of ticagrelor over a 30-day time horizon. For urgent cardiac surgery, the use of CytoSorb was less costly than any of the three comparators-delaying surgery for natural washout without adjunctive therapy, adjunctive therapy with short-acting antiplatelet agents, or adjunctive therapy with low-molecular-weight heparin. Results from the PSAs showed that CytoSorb has a high probability of being cost saving (99% in emergent cardiac surgery and 53-77% in urgent cardiac surgery, depending on the comparators). Cost savings derive from fewer transfusions of blood products and re-thoracotomies, and shorter stay in the hospital/intensive care unit. CONCLUSIONS: The implementation of CytoSorb as an intraoperative intervention for patients receiving ticagrelor undergoing emergent or urgent cardiac surgery is a cost-saving strategy, yielding improvement in perioperative and postoperative outcomes and decreased health resource use.

E-cigarette use is associated with a self-reported diagnosis of prediabetes in never cigarette smokers: Results from the behavioral risk factor surveillance system survey.

BACKGROUND: The use of e-cigarettes is increasing in the US but there is still a paucity of research on the metabolic effects of e-cigarette use. The goal of this work was to determine the association between e-cigarette use and self-reported prediabetes in adult never cigarette smokers. METHOD: The 2017 cross sectional Behavioral Risk Factor Surveillance System (BRFSS) survey data was used for the analysis. Current e-cigarette users reported daily or someday use of e-cigarettes and former e-cigarette users reported no current use of e-cigarettes. Participants who reported a history of diabetes, gestational prediabetes/ diabetes were excluded. Odds ratios were calculated to determine the association between e-cigarette use and self-reported prediabetes in never cigarette smokers after adjusting for potential confounders. RESULTS: There were a total of 154,404 participants that met the inclusion criteria. Of those participants, there were 143,952 never, 1339 current and 7625 former e-cigarette users. Current e-cigarette users had an increased odds of reporting a diagnosis of prediabetes 1.97 (95% CI 1.25-3.10) compared to never e-cigarette users. After stratifying by gender, men and women had an increased odds ratio of reporting a diagnosis of prediabetes 2.36 (95% CI 1.26-4.40) and 1.88 (95% CI 1.00-3.53) respectively when compared to never e-cigarette users. There was no association between former e-cigarette use and a self-reported diagnosis of prediabetes. CONCLUSION: Our findings show that e-cigarette use may be associated with self-reported prediabetes. Further evaluation is needed in prospective studies.

Adult E-Cigarettes Use Associated with a Self-Reported Diagnosis of COPD.

The use of electronic cigarettes (e-cigarettes) has increased in the US, but little is known about the effects of these products on lung health. The main purpose of this study was to examine the association between e-cigarette use and a participant's report of being diagnosed with chronic obstructive pulmonary disease (COPD) in a nationally representative sample of adults. Methods: The first wave of the Population Assessment of Tobacco and Health (PATH) survey adult data was used (N = 32,320). Potential confounders between e-cigarette users and non-users were balanced using propensity score matching. Odds ratios (OR) were calculated to examine the association between e-cigarette use and COPD in the propensity-matched sample, the entire sample, different age groups, and in nonsmokers. Replicate weights and balanced repeated replication methods were utilized to account for the complex survey design. Results: Of the 3642 participants who met the criteria for e-cigarette use, 2727 were propensity matched with 2727 non e-cigarette users. In the propensity-matched sample, e-cigarette users were more likely to report being diagnosed with COPD (OR 1.43, 95% confidence interval [CI] 1.12-1.85) than non-e-cigarette users after adjusting for confounders. The result was similar in the entire sample and in the different age subgroups. Among nonsmokers, the odds of reporting a COPD diagnosis were even greater among e-cigarette users (OR 2.94, 95% CI 1.73-4.99) compared to non-e-cigarette users. Conclusion: Our findings demonstrate that e-cigarette use was associated with a reported diagnosis of COPD among adults in the US. Further research is necessary to characterize the nature of this association and on the long-term effects of using e-cigarettes.