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Aim: In this study, we aimed to provide a nationally representative estimate of the economic burden of chronic obstructive pulmonary disease (COPD) by examining direct medical costs among individuals aged 45 years and older in the USA., Methods: Medical Expenditure Panel Survey (2017-2018) data were used to estimate the direct medical costs associated with COPD. All-cause (unadjusted) cost and COPD-specific (adjusted) cost were determined for the various service categories using a regression-based approach among patients with COPD. We developed a weighted two-part model and adjusted for various demographic, socioeconomic, and clinical characteristics., Results: The study sample consisted of 23,590 patients, of which 1073 had COPD. Patients with COPD had a mean age of 67.4 years (standard error (SE): 0.41), and the total all-cause mean medical cost per patient per year (PPPY) was 2018 US $19,449 (SE: US $865), of which US $6145 (SE: US $295) was for prescription drugs. Using the regression approach, the mean total COPD-specific cost was US $4322 (SE: US $577) PPPY, with prescription drugs contributing US $1887 (SE: 216) PPPY. These results represented an annual total COPD-specific cost of US $24.0 billion, with prescription drugs contributing US $10.5 billion. The mean annual out-of-pocket spending accounted for 7.5% (mean: US $325) of the total COPD-specific cost; for COPD-specific prescription drug cost, 11.3% (mean: US $212) was out-of-pocket cost., Conclusion: COPD poses a significant economic burden on healthcare payers and patients 45 years of age and older in the USA. While prescription drugs accounted for almost half of the total cost, more than 10% of the prescription drug cost was out-of-pocket., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Chronic obstructive pulmonary disease (COPD) is an age-related condition that has been associated with early telomere attrition; the clinical implications of telomere shortening in COPD are not well known. In this study we aimed to determine the relationship of the epigenetic regulation of telomeric length in peripheral blood with the risk of exacerbations and hospitalization in patients with COPD., Methods: Blood DNA methylation profiles were obtained from 292 patients with COPD enrolled in the placebo arm of the Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated with Chronic Obstructive Pulmonary Disease (MACRO) Study and who were followed for 1-year. We calculated telomere length based on DNA methylation markers (DNAmTL) and related this biomarker to the risk of exacerbation and hospitalization and health status (St. George Respiratory Questionnaire [SGRQ]) score over time using a Cox proportional hazards model. We also used linear models to investigate the associations of DNAmTL with the rates of exacerbation and hospitalization (adjusted for chronological age, lung function, race, sex, smoking, body mass index and cell composition)., Results: Participants with short DNAmTL demonstrated increased risk of exacerbation (P = 0.02) and hospitalization (P = 0.03) compared to those with longer DNAmTL. DNAmTL age acceleration was associated with higher rates of exacerbation (P = 1.35 × 10 -04 ) and hospitalization (P = 5.21 × 10 -03 ) and poor health status (lower SGRQ scores) independent of chronological age (P = 0.03)., Conclusion: Telomeric age based on blood DNA methylation is associated with COPD exacerbation and hospitalization and thus a promising biomarker for poor outcomes in COPD., (© 2021. The Author(s).)

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases that impose a significant economic burden on Medicaid. Inhalers are the mainstay treatment for relieving symptoms and improving outcomes for COPD and asthma patients. OBJECTIVE: To describe the total spending and trends of Medicaid expenditures on inhalers between 2012 and 2018 in the United States. METHODS: We analyzed the deidentified data from the Medicaid Drug Spending Dashboard and utilization datasets from 2012 to 2018. We identified 9 classes of inhalers and described the Medicaid total spending on and relative annual changes for those inhalers. We also described the spending on available generic inhalers and compared the Medicaid spending by manufacturers during this time frame. RESULTS: Medicaid spent $26.2 billion on inhalers from 2012 to 2018. This spending increased by $2.5 billion (120%) over this time frame. During this specified period, the highest Medicaid spending was on the group of inhaled corticosteroid (ICS)-containing inhalers ($14.9 billion). Within this group, the inhaler class of ICS/long-acting beta-2 adrenoceptor agonists contributed to the highest Medicaid spending (53%), with a growth of 607% between 2012 and 2018. Of the $26.2 billion that Medicaid spent on inhalers, $35.5 million (less than 0.01%) was spent on 2 generic inhalers: fluticasone propionate with salmeterol and levalbuterol tartrate hydrofluoroalkane. CONCLUSIONS: Between 2012 and 2018, on average, $3.5 billion per year was spent by Medicaid on inhalers. Decreasing the price of inhalers by introducing more generic inhalers in the market can potentially reduce the cost burden on Medicaid. DISCLOSURES : This study was funded by the American Foundation for Pharmaceutical Education (AFPE). The funders had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript. The authors declare no conflicts of interest.

Background: Total serum IgE (tIgE) is an important intermediate phenotype of allergic disease. Whole genome genetic association studies across ancestries may identify important determinants of IgE., Objective: We aimed to increase understanding of genetic variants affecting tIgE production across the ancestry and allergic disease spectrum by leveraging data from the National Heart, Lung and Blood Institute Trans-Omics for Precision Medicine program; the Consortium on Asthma among African-ancestry Populations in the Americas (CAAPA); and the Atopic Dermatitis Research Network (N = 21,901)., Methods: We performed genome-wide association within strata of study, disease, and ancestry groups, and we combined results via a meta-regression approach that models heterogeneity attributable to ancestry. We also tested for association between HLA alleles called from whole genome sequence data and tIgE, assessing replication of associations in HLA alleles called from genotype array data., Results: We identified 6 loci at genome-wide significance (P < 5 × 10 -9 ), including 4 loci previously reported as genome-wide significant for tIgE, as well as new regions in chr11q13.5 and chr15q22.2, which were also identified in prior genome-wide association studies of atopic dermatitis and asthma. In the HLA allele association study, HLA-A∗02:01 was associated with decreased tIgE level (P discovery  = 2 × 10 -4 ; P replication  = 5 × 10 -4 ; P discovery+replication  = 4 × 10 -7 ), and HLA-DQB1∗03:02 was strongly associated with decreased tIgE level in Hispanic/Latino ancestry populations (P Hispanic/Latino discovery+replication  = 8 × 10 -8 )., Conclusion: We performed the largest genome-wide association study and HLA association study of tIgE focused on ancestrally diverse populations and found several known tIgE and allergic disease loci that are relevant in non-European ancestry populations., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In the United States, COPD is a leading cause of mortality, with a substantial societal health and economic burden. With anticipated population growth, it is important for various stakeholders to have an estimate for the projected burden of disease., Research Question: The goal of this study was to model the 20-year health and economic burden of COPD, from 2019 to 2038, in the United States., Study Design and Methods: Using country-specific data from published literature and publicly available datasets, a dynamic open cohort Markov model was developed in a probabilistic Monte Carlo simulation. Population growth was modeled across different subgroups of age, sex, and smoking. The COPD prevalence rates were calibrated for different subgroups, and distributions of severity grades were modeled based on smoking status. Direct costs, indirect absenteeism costs, losses of quality-adjusted life years (QALYs), and number of exacerbations and deaths associated with COPD were projected., Results: The 20-year discounted direct medical costs attributable to COPD were estimated to be $800.90 billion (95% credible interval [CrI], 565.29 billion-1,081.29 billion), with an expected $337.13 billion in male subjects and $463.77 billion in female subjects. The 20-year discounted indirect absenteeism costs were projected to be $101.30 billion (70.82 billion-137.41 billion). The 20-year losses of QALYs, number of exacerbations, and number of deaths associated with COPD were 45.38 million (8.63 million-112.07 million), 315.08 million (228.59 million-425.33 million), and 9.42 million (8.93 million-9.93 million), respectively. The proportion of disease burden attributable to continued smoking was 34% in direct medical costs, 35% in indirect absenteeism costs, and 37% in losses of QALYs over 20 years., Interpretation: This study projects the substantial burden of COPD that the American society is expected to incur with current patterns for treatments and smoking rates. Mitigating such burden requires targeted budget appropriations and cost-effective interventions., (Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Chronic obstructive pulmonary disease (COPD) is a heterogenous condition. This study aims to quantify the heterogeneity of Health-related Quality of Life (HRQoL), and identify subgroups with the lowest HRQoL, in COPD patients in the United States (US). Methods Data from 2008-2015 Medical Expenditure Panel Survey were used to examine the heterogeneity of HRQoL between different COPD subgroups using mixed-effects modeling and G-computation. The Physical Composite Summary (PCS) and Mental Composite Summary (MCS) scores from the Short-Form-12 questionnaire were utilized. We also compared the heterogeneity of HRQoL in our COPD cohort against that in a matched non-COPD cohort. Results The final sample consisted of 1,866 (weighted = 19,952,143) COPD patients with a mean age of 63.2 years (Standard error (SE):0.38), mean MCS score of 46.84 (SE:0.35), and mean PCS score of 35.65 (SE:0.32). The adjusted MCS and PCS scores ranged from 36.19 to 53.06, and from 25.52 to 48.27, respectively, for COPD subgroups. COPD patients had statistically significantly lower MCS and PCS scores by 4.61, and 5.86 points, respectively, compared to the matched non-COPD cohort, and MCS scores showed a wider variability in the COPD cohort. Conclusion Our study quantifies substantial heterogeneity of HRQoL in COPD in the US and provides evidence for prioritizing COPD subgroups with the lowest HRQoL for targeted interventions.

Rationale: Colder temperatures have been shown to increase hospitalization and mortality rates in adults with chronic obstructive pulmonary disease (COPD) and cardiac disease. Seasonal influences on exacerbation rates in adults with severe COPD but without significant cardiovascular disease are unclear. In addition, regional variations in COPD exacerbations in North America have not yet been explored., Objectives: In this study, we sought to determine the seasonal and regional variability in exacerbation rates in those with COPD but without significant cardiovascular risk factors., Methods: We studied adults without cardiovascular risk factors from STATCOPE (Simvastatin in the Prevention of COPD Exacerbations) and placebo arm of MACRO (Azithromycin for the Prevention of Exacerbations of COPD) studies. Forty-five study sites were divided into climate regions in Canada and the United States; seasons were defined as winter, spring, summer, and fall. The primary outcome was the rate of COPD exacerbation. Secondary outcomes included time to first exacerbation, severity of exacerbations, all-cause mortality, and antibiotic and steroid use., Results: We analyzed 1,175 subjects with a mean age of 63.3 ± 8.6 years, forced expiratory volume in 1 second of 41.5 ± 17.1% predicted, and 53.6 ± 29.4 pack-years of smoking history. The COPD exacerbation rate was higher in winter (0.13 exacerbations/person-month) than in spring, summer, and fall (0.11, 0.079, and 0.10 exacerbations/person-month, respectively) (P < 0.001). Summer had the highest proportion of severe exacerbations (40.5%) compared with spring, fall, and winter (32.6%, 34.7%, and 33.1%, respectively) (P = 0.004). Mortality was highest in spring and winter (34% and 30%, respectively). There was significant regional variability in the time to first exacerbation, with the Southeast and West having longer median times to first exacerbation (350 and 342 d, respectively, compared with 184 d in other regions) (P < 0.001)., Conclusions: Significant seasonal and regional variability exist in the rate and severity of exacerbations and overall mortality in adults with COPD without cardiovascular disease.

Background: Donor-to-recipient lung size matching at lung transplantation (LTx) can be estimated by the predicted total lung capacity (pTLC) ratio (donor pTLC/recipient pTLC). We aimed to determine whether the pTLC ratio is associated with the risk of primary graft dysfunction (PGD) after bilateral LTx (BLT)., Methods: We calculated the pTLC ratio for 812 adult BLTs from the Lung Transplant Outcomes Group between March 2002 to December 2010. Patients were stratified by pTLC ratio >1.0 ("oversized") and pTLC ratio ≤1.0 ("undersized"). PGD was defined as any ISHLT Grade 3 PGD (PGD3) within 72 hours of reperfusion. We analyzed the association between risk factors and PGD using multivariable conditional logistic regression. As transplant diagnoses can influence the size-matching decisions and also modulate the risk for PGD, we performed pre-specified analyses by assessing the impact of lung size mismatch within diagnostic categories., Results: In univariate analyses oversizing was associated with a 39% lower odds of PGD3 (OR 0.61, 95% CI, 0.45-0.85, p = 0.003). In a multivariate model accounting for center-effects and known PGD risks, oversizing remained independently associated with a decreased odds of PGD3 (OR 0.58, 95% CI 0.38 to 0.88, p = 0.01). The risk-adjusted point estimate was similar for the non-COPD diagnosis groups (OR 0.52, 95% CI 0.32 to 0.86, p = 0.01); however, there was no detected association within the COPD group (OR 0.72, 95% CI 0.29 to 1.78, p = 0.5)., Conclusion: Oversized allografts are associated with a decreased risk of PGD3 after BLT; this effect appears most apparent in non-COPD patients., (Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)