A retrospective analysis to identify predictors of COPD-related rehospitalization.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is often associated with recurrent hospitalizations. This study aimed to identify factors related to COPD rehospitalization. METHODS: A national US claims database was used to identify patients, aged ≥40 years, hospitalized for COPD. Their first COPD-related hospital admission date in 2009 was set as the index date, with post-discharge COPD-related rehospitalization assessed for 180 days post-index date. Data were analyzed for: 1) all eligible patients in whom early COPD-related rehospitalization was evaluated (1-30 days post discharge; all-patient cohort) and 2) a patient subset not rehospitalized early in whom late COPD-related rehospitalization was evaluated (>30 days post discharge to 180 days post-index date; late cohort). Logistic regressions controlling for age and sex assessed potential COPD-related rehospitalization predictors. Variables from the 360-day pre-index period and index hospitalization were evaluated for each cohort, and 30-day post-discharge variables evaluated for the late cohort. RESULTS: Of 3612 patients with an index hospitalization, 4.8 % (174) had an early COPD-related rehospitalization, and of the remaining 3438 patients, 13.7 % (471) had a late COPD-related rehospitalization. Several pre-index variables were predictive of early COPD-related rehospitalization including: pneumonia; comorbidities; COPD-related drug therapies; and prior hospitalizations. In patients not rehospitalized early, the strongest predictor of late COPD-related rehospitalization was pre-index COPD-related hospitalization (OR = 3.64 [P < 0.001]). The strongest index hospitalization factors predictive of late COPD-related rehospitalization were use of steroids (any route: OR = 1.62 [P = 0.007]) and nebulizers (OR = 1.65 [P = 0.007]); neither predicted early COPD-related rehospitalization. Generally, factors predicting COPD-related rehospitalization were similar in both cohorts. CONCLUSIONS: Several pre-index variables were associated with COPD-related rehospitalization. A strong predictor of COPD-related rehospitalization was prior hospitalization during the pre-index period, particularly with a primary COPD diagnosis, whilst other predictive factors related to increased COPD severity; these may be useful indicators for COPD-related rehospitalization risk assessment. Some factors, e.g., recurrent pneumonia and exacerbations, may be modifiable.

Renal and hepatobiliary dysfunction in chronic obstructive pulmonary disease.

PURPOSE OF REVIEW: This review examines the associations between chronic obstructive pulmonary disease (COPD) and renal and hepatobiliary diseases, with emphasis on the epidemiology and clinical outcomes, along with current information on pathophysiologic mechanisms and risk factors. RECENT FINDINGS: Glomerular filtration, sodium retention, and waste excretion are abnormal in COPD and sensitive to hypoxemia and hypercarbia, but variably responsive to oxygen administration and angiotensin-converting enzyme inhibition. Newer concepts about the role of hypoxia on the progression of chronic renal failure, and improved understanding about the relationships between COPD, decreased arterial compliance, and renal glomerular injury, are bringing new insights about potential causal mechanisms between COPD and kidney diseases. Other than the well known relationship between cor pulmonale and passive liver congestion, little was known about the relationships between COPD and liver diseases until recent population-based surveys demonstrated that COPD patients have substantially elevated risk for specific hepatobiliary system diseases. SUMMARY: Renal complications of COPD are common especially among patients with hypoxemia and hypercarbia. Renal-endocrine mechanisms, tissue hypoxia, and vascular rigidity have roles in the pathophysiology, but understanding of causal relationships is not precise. COPD patients have increased risk for hepatobiliary diseases and asymptomatic elevations of hepatic transaminases, which fortunately have relatively low prevalence.

The epidemiology and treatment of anal fissures in a population-based cohort.

BACKGROUND: Anal fissure (AF) is regarded as a common problem, but there are no published epidemiologic data, nor information on current treatment. The purpose of this study was to examine the incidence, associated comorbidities, and treatment of AF in a population-based cohort. METHODS: We conducted a retrospective analysis of all persons who were enrolled in one large regional managed care system and treated for AF during calendar years 2005-2011. All persons aged 6 years or older who had a clinic, hospitalization, or surgical procedure associated with AF were identified from utilization data. To identify comorbidities associated with AF, each case was matched by age and gender to 3 controls. RESULTS: There were 1,243 AF cases, including 721 (58%) females and 522 (42%) males; 150 (12%) of the cases occurred in children aged 6-17 years. The overall annual incidence was 0.11% (1.1 cases per 1000 person-years), but ranged widely by age [0.05% in patients 6-17 years to 0.18% in patients 25-34 years]. The incidence also varied by sex, and was significantly higher among females 12-24 years, and among males 55-64 years (P < 0.001). Comorbidities associated with AF included chronic constipation (prevalence 14.2% vs 3.6%), hypothyroidism (14.7% vs 10.4%), obesity (13.0% vs 7.7%), and solid tumors without metastasis (5.2% vs 3.7%) (P < 0.001 for all comparisons). A total of 448 were dispensed a topical prescription medication, 31 had botulinum toxin injection, and only 13 had lateral internal sphincterotomy. CONCLUSIONS: AF is a common clinical problem, and the incidence varies substantially by age and sex. Constipation, obesity, and hypothyroidism are associated comorbidities. Most patients are prescribed topical treatments, although it appears that many prescriptions are never filled. Surgical interventions for AF including botulinum toxin and lateral internal sphincterotomy are uncommon.

Disease Burden and Health-Related Quality of Life (HRQoL) of Chronic Obstructive Pulmonary Disease (COPD) in the US - Evidence from the Medical Expenditure Panel Survey (MEPS) from 2016-2019.

Purpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with reduced life expectancy, increased morbidity, mortality, and cost. This study characterized the US COPD burden, including socioeconomic and health-related quality of life (HRQoL) outcomes. Study Design and Methods: In this retrospective, cross-sectional study using nationally representative estimates from Medical Expenditures Survey (MEPS) data (2016-2019), adults (≥18 years) living with and without COPD were identified. Adults living without COPD (control cohort) and with COPD were matched 5:1 on age, sex, geographic region, and entry year. Demographics, clinical characteristics, socioeconomic, and generic HRQoL measures were examined to include a race-stratified analysis of people living with COPD. Results: A total of 4,135 people living with COPD were identified; the matched dataset represented a weighted non-institutionalized population of 11.3 million with and 54.2 million people without COPD. Among people living with COPD, 66.3% had ≥1 COPD-related condition; 62.7% had ≥1 cardiovascular condition, compared to 33.5% and 50.5% without COPD. More people living with COPD were unemployed (56.2% vs 45.3%), unable to work due to illness/disability (30.1% vs 12.1%), had problems paying bills (16.1% vs 8.8%), reported poorer perceived health (fair/poor: 36.2% vs 14.4%), missed more working days due to illness/injury per year (median, 2.5 days vs 0.0 days), and had limitations in physical functioning (40.1% vs 19.4%) (all P<0.0001). In race-stratified analyses for people living with COPD, people self-reporting as Black had higher prevalence of cardiovascular-risk conditions, poorer socioeconomic and HRQoL outcomes, and higher healthcare expenses than White or Other races. Conclusion: Adults living with COPD had higher clinical disease burden, lower socioeconomic status, and reduced HRQoL than those without, with greater disparities among Black people living with COPD compared to White and other races. Understanding the characteristics of patients helps address care disparities and access challenges.

Development and validation of a claims-based algorithm to identify moderate exacerbations in patients with asthma treated in the US.

INTRODUCTION: Definitions of moderate asthma exacerbation have been inconsistent, making their economic burden difficult to assess. An algorithm to accurately identify moderate exacerbations from claims data is needed. METHODS: A retrospective cohort study of Reliant Medical Group patients aged ≥18 years, with ≥1 prescription claim for inhaled corticosteroid/long-acting ß2-agonist, and ≥1 medical claim with a diagnosis code for asthma was conducted. The objective was to refine current algorithms to identify moderate exacerbations in claims data and assess the refined algorithm's performance. Positive and negative predictive values (PPV and NPV) were assessed via chart review of 150 moderate exacerbations events and 50 patients without exacerbations. Sensitivity analyses assessed alternative algorithms and compared healthcare resource utilization (HRU) between algorithm-identified patients (claims group) and those confirmed by chart review (confirmed group) to have experienced a moderate exacerbation. RESULTS: Algorithm-identified moderate exacerbations were: visit of ≤1 day with an asthma exacerbation diagnosis OR visit of ≤1 day with selected asthma diagnoses AND ≥1 respiratory pharmacy claim, excluding systemic corticosteroids, within 14 days after the first claim. The algorithm's PPV was 42%; the NPV was 78%. HRU was similar for both groups. CONCLUSION: This algorithm identified potential moderate exacerbations from claims data; however, the modest PPV underscores its limitations in identifying moderate exacerbations, although performance was partially due to identification of previously unidentified severe exacerbations. Application of this algorithm in future claims-based studies may help quantify the economic burden of moderate and severe exacerbations in asthma when an algorithm identifying severe exacerbations is applied first.

Frequency and economic burden of exacerbations in inhaled corticosteroid/long-acting beta-agonist-treated patients with asthma: A retrospective US claims study.

INTRODUCTION: Despite adherence to inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) therapy, many patients with asthma experience moderate exacerbations. Data on the impact of moderate exacerbations on the healthcare system are limited. This study assessed the frequency and economic burden of moderate exacerbations in patients receiving ICS/LABA. METHODS: Retrospective, longitudinal study analyzed data from Optum's de-identified Clinformatics® Data Mart Database recorded between October 1, 2015, and December 31, 2019. Eligibility criteria included patients ≥18 years of age with ≥1 ICS/LABA claim and ≥1 medical claim for asthma in the 12 months pre-index (first ICS/LABA claim). Primary objectives included describing moderate exacerbation frequency, and associated healthcare resource utilization (HRU) and costs. A secondary objective was assessing the relationship between moderate exacerbations and subsequent risk of severe exacerbations. Patients were stratified by moderate exacerbation frequency in the 12 months post index. Moderate exacerbations were identified using a newly developed algorithm. RESULTS: In the first 12 months post index 61.6% of patients experienced ≥1 moderate exacerbation. Mean number of asthma-related visits was 4.1 per person/year and median total asthma-related costs was $3544. HRU and costs increased with increasing exacerbation frequency. Outpatient and inpatient visits accounted for a similar proportion of these costs. Moderate exacerbations were associated with an increased rate and risk of future severe exacerbations (incidence rate ratio, 1.56; hazard ratio, 1.51 [both p < 0.001]). CONCLUSIONS: This study highlighted that a high proportion of patients continue to experience moderate exacerbations despite ICS/LABA therapy and subsequently experience increased economic burden and risk of future severe exacerbations.

Development of a modified BODE index as a mortality risk measure among older adults with and without chronic obstructive pulmonary disease.

The BODE index was developed as a prognostic mortality risk tool for persons with chronic obstructive pulmonary disease (COPD). It incorporates 4 measures: body mass index, lung obstruction, dyspnea, and exercise capacity. The intent of this study was to examine how well a BODE-like index constructed using a simpler lung function measure, peak expiratory flow, in combination with physical functioning and symptom information more readily found in survey data (a quasi-BODE index), performs in identifying persons at higher risk of mortality and whether it may be extended as an assessment of mortality risk to persons without diagnosed COPD. Using US national survey data from the Health Retirement Study for 2006-2010, each unit increase in the quasi-BODE index score was associated with a multiplicative 50% increase in mortality risk (odds ratio = 1.50, 95% confidence interval: 1.41, 1.59). The quasi-BODE index is a multidimensional health status instrument based on the BODE index, which is a good predictor of mortality. The quasi-BODE index was compiled using simple measures of physical and respiratory function. It is a potentially useful prognostic instrument for older adult populations with or without COPD, including those with severe physical limitations, particularly when combined with demographic factors and comorbid conditions.

The epidemiology, diagnosis, and cost of dyspepsia and Helicobacter pylori gastritis: a case-control analysis in the Southwestern United States.

BACKGROUND: Dyspepsia is among the most common complaints evaluated by gastroenterologists, but there are few studies examining its current epidemiology, evaluation, and costs. We examined these issues in a large managed care system in the Southwestern United States. METHODS: We conducted a retrospective case-control analysis of adults with incident dyspepsia or a Helicobacter pylori-related condition in years 2006 through 2010 using utilization data. Medical record abstraction of 400 cases was conducted to obtain additional clinical information. RESULTS: A total of 6989 cases met all inclusion and exclusion criteria. Women had a substantially higher risk of dyspepsia than men (14 per 1000 per year vs 10 per 1000; p < .001), and the incidence of dyspepsia increased with age such that persons in their seventh decade had almost twice the risk of those aged 18-29. Hispanic persons had a significantly higher risk of dyspepsia and positive H. pylori testing. Dyspepsia cases had a higher prevalence of other chronic comorbidities than their matched controls. Dyspepsia patients had healthcare costs 54% higher than controls even before the diagnosis was made, and costs in the initial diagnostic period were $483 greater per person, but subsequent costs were not greatly affected. Among those aged 55 and younger, the "test and treat" approach was used in 53% and another 18% had an initial esophagogastroduodenoscopy, as compared to 47 and 27%, respectively, among those over the age of 55. CONCLUSIONS: Women and older adults have a higher incidence of dyspepsia than previously appreciated, and Hispanics in this region also have a higher risk. Current guidelines for dyspepsia evaluation are only loosely followed.

National and Local Direct Medical Cost Burden of COPD in the United States From 2016 to 2019 and Projections Through 2029.

BACKGROUND: Despite the significant burden posed by COPD to health care systems, there is a lack of up-to-date information quantifying the general COPD burden, costs, and long-term projections to various stakeholders in the United States. RESEARCH QUESTION: What are the updated state-specific and nationwide estimates of the COPD disease burden and direct costs in 2019, along with projections of COPD-attributable medical costs through 2029? STUDY DESIGN AND METHODS: A cross-sectional, retrospective study design using the 2016 to 2019 Medical Expenditure Panel Survey, 2019 American Community Survey, and 2019 Behavioral Risk Factor Surveillance System data was applied to generate COPD-attributable expenditure estimates. Cost projections for the years 2020 to 2029 were based on 2017 national population projections reported by the US Census Bureau, and all costs were adjusted to 2019 US dollars. RESULTS: In total, 4,135 people living with COPD were included; a higher proportion had other concurrent conditions such as cardiovascular-related conditions compared with people without COPD (n = 86,021). Overall, in 2019, COPD-attributable medical costs after adjusting for demographic characteristics and 19 concurrent conditions (including COPD-related and non-COPD-related conditions) were estimated at $31.3 billion, with state-specific cost estimates reporting wide variation, from $44.8 million in Alaska to $3.1 billion in Florida. Nationwide COPD-attributable medical costs borne by payer type were as follows: private insurance, $11.4 billion; Medicare, $10.8 billion; and Medicaid, $3.0 billion. Projections of national medical costs attributable to COPD are reported to increase to $60.5 billion in 2029. INTERPRETATION: Understanding the current disease and economic burden of COPD in the United States, along with the projected costs attributable to COPD in the next decade, will highlight unmet needs and gaps in care that help inform health care decision-makers in planning future actions to alleviate this disease burden.

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program.

Background: In this study, we compare management of patients with high-risk chronic obstructive pulmonary disease (COPD) in the United States to national and international guidelines and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). Methods: Patients were identified from the DARTNet Practice Performance Registry and categorized into three high-risk cohorts in each year from 2011 to 2019: newly diagnosed (≤12 months after diagnosis), already diagnosed, and patients with potential undiagnosed COPD. Patients were considered high-risk if they had a history of exacerbations or likely exacerbations (respiratory consult with prescribed medication). Descriptive statistics for 2019 are reported, along with annual trends. Findings: In 2019, 10% (n = 16,610/167,197) of patients met high-risk criteria. Evidence of spirometry for diagnosis was low; in 2019, 81% (n = 1228/1523) of patients newly diagnosed at high-risk had no record of spirometry/peak expiratory flow in the 12 months pre- or post-diagnosis and 43% (n = 651/1523) had no record of COPD symptom review. Among those newly and already diagnosed at high-risk, 52% (n = 4830/9350) had no evidence of COPD medication. Interpretation: Findings suggest inconsistent adherence to evidence-based guidelines, and opportunities to improve identification, documentation of services, assessment, therapeutic intervention, and follow-up of patients with COPD. Funding: This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

Limited lung function: impact of reduced peak expiratory flow on health status, health-care utilization, and expected survival in older adults.

The authors examined whether peak expiratory flow (PEF) is a valid measure of health status in older adults. Survey and test data from the 2006 and 2008 cycles of the Health and Retirement Study, a longitudinal study of US adults over age 50 years (with biennial surveys initiated in 1992), were used to develop predicted PEF regression models and to examine relations between low PEF values and other clinical factors. Low PEF (<80% of predicted value) was prevalent among persons with chronic conditions, including frequent pain, obstructive lung disease, heart disease, diabetes, and psychological distress. Persons with higher physical disability scores had substantially higher adjusted odds of having low PEF, on par with those for conditions known to be associated with poor health (cancer, heart disease, and stroke). In a multivariate regression model for difficulty with mobility, PEF remained an independent factor (odds ratio (OR) = 1.69, 95% confidence interval (CI): 1.53, 1.86). Persons with low PEF in 2006 were more likely to be hospitalized (OR = 1.26, 95% CI: 1.10, 1.43) within the subsequent 2 years and to estimate their chances of surviving for 10 or more years at less than 50% (OR = 1.69, 95% CI: 1.24, 2.30). PEF is a valid measure of health status in older persons, and low PEF is an independent predictor of hospitalization and poor subjective mortality assessment.

Frailty Among Older Individuals with and without COPD: A Cohort Study of Prevalence and Association with Adverse Outcomes.

Rationale: Frailty prevalence estimates among individuals with COPD have varied widely, and few studies have investigated relationships between frailty and adverse outcomes in a COPD population. Objectives: Describe frailty prevalence among individuals with and without COPD and examine associations between frailty and mortality and other adverse outcomes in the next two years. Methods: This was an observational cohort study using Health and Retirement Study data (2006-2018) of community living individuals ages 50-64 and ≥65 with and without COPD (non-COPD). Frailty (Fried phenotype [5 items], and a modified Frailty Index-Comprehensive Geriatric Assessment [Enhanced FI-CGA] [37 items], and debility (modified BODE Index [4 items]) were assessed. Two-year post-assessment outcomes (mortality, ≥1 inpatient stay, home health and skilled nursing facility (SNF) use) were reviewed in a population matched 3:1 (non-COPD: COPD) on age, sex, race, and year using univariate and multivariate logistic regression (adjusted for morbidities). Area-under-the-curve (AUC) was used to evaluate regressions. Results: The study included 18,979 survey observations for age 50-64, and 24,162 age ≥65; 7.8% and 12.0% respectively reporting a diagnosis of COPD. Fried phenotype frailty prevalence for age ≥65 was 23.1% (COPD) and 9.4% (non-COPD), and for the Enhanced FI-CGA, 45.9% (COPD) and 22.4% (non-COPD). Two-year mortality for COPD was more than double non-COPD for age 50-64 (95% CI: 3.8-5.9% vs 0.7-1.3%) and age ≥65 (95% CI: 11.9-14.3% vs 5.6-6.6%). Inpatient utilization, home health care use, or at least temporary SNF placement were also more frequent for COPD. Measures were predictive of adverse outcomes. In adjusted models, the Fried phenotype and modified BODE score performed similarly, and both performed better than the Enhanced FI-CGA index. AUC values were higher for morality regressions. Conclusion: Frailty prevalence among individuals with COPD in this national survey is substantially greater than without COPD, even at pre-retirement (50-64 years). These measures identify patients with increased risk of poor outcomes.

Identifying and characterizing COPD patients in US managed care. A retrospective, cross-sectional analysis of administrative claims data.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death among US adults and is projected to be the third by 2020. In anticipation of the increasing burden imposed on healthcare systems and payers by patients with COPD, a means of identifying COPD patients who incur higher healthcare utilization and costs is needed. METHODS: This retrospective, cross-sectional analysis of US managed care administrative claims data describes a practical way to identify COPD patients. We analyze 7.79 million members for potential inclusion in the COPD cohort, who were continuously eligible during a 1-year study period. A younger commercial population (7.7 million) is compared with an older Medicare population (0.115 million). We outline a novel approach to stratifying COPD patients using "complexity" of illness, based on occurrence of claims for given comorbid conditions. Additionally, a unique algorithm was developed to identify and stratify COPD exacerbations using claims data. RESULTS: A total of 42,565 commercial (median age 56 years; 51.4% female) and 8507 Medicare patients (median 75 years; 53.1% female) were identified as having COPD. Important differences were observed in comorbidities between the younger commercial versus the older Medicare population. Stratifying by complexity, 45.0%, 33.6%, and 21.4% of commercial patients and 36.6%, 35.8%, and 27.6% of older patients were low, moderate, and high, respectively. A higher proportion of patients with high complexity disease experienced multiple (≥2) exacerbations (61.7% commercial; 49.0% Medicare) than patients with moderate- (56.9%; 41.6%), or low-complexity disease (33.4%; 20.5%). Utilization of healthcare services also increased with an increase in complexity. CONCLUSION: In patients with COPD identified from Medicare or commercial claims data, there is a relationship between complexity as determined by pulmonary and non-pulmonary comorbid conditions and the prevalence of exacerbations and utilization of healthcare services. Identification of COPD patients at highest risk of exacerbations using complexity stratification may facilitate improved disease management by targeting those most in need of treatment.

Development and Validation of a Healthcare Utilization-Based Algorithm to Identify Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

Introduction: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are important events that may precipitate other adverse outcomes. Accurate AECOPD event identification in electronic administrative data is essential for improving population health surveillance and practice management. Objective: Develop codified algorithms to identify moderate and severe AECOPD in two US healthcare systems using administrative data and electronic medical records, and validate their performance by calculating positive predictive value (PPV) and negative predictive value (NPV). Methods: Data from two large regional integrated health systems were used. Eligible patients were identified using International Classification of Diseases (Ninth Edition) COPD diagnosis codes. Two algorithms were developed: one to identify potential moderate AECOPD by selecting outpatient/emergency visits associated with AECOPD-related codes and antibiotic/systemic steroid prescriptions; the other to identify potential severe AECOPD by selecting inpatient visits associated with corresponding codes. Algorithms were validated via patient chart review, adjudicated by a pulmonologist. To estimate PPV, 300 potential moderate AECOPD and 250 potential severe AECOPD events underwent review. To estimate NPV, 200 patients without any AECOPD identified by the algorithms (100 patients each without moderate or severe AECOPD) during the two years following the index date underwent review to identify AECOPD missed by the algorithm (false negatives). Results: The PPVs (95% confidence interval [CI]) for both moderate and severe AECOPD were high: 293/298 (98.3% [96.1-99.5]) and 216/225 (96.0% [92.5-98.2]), respectively. NPV was lower for moderate AECOPD (75.0% [65.3-83.1]) than for severe AECOPD (95.0% [88.7-98.4]). Results were consistent across both healthcare systems. Conclusion: This study developed healthcare utilization-based algorithms to identify moderate and severe AECOPD in two separate healthcare systems. PPV for both algorithms was high; NPV was lower for the moderate algorithm. Replication and consistency of results across two healthcare systems support the external validity of these findings.

Pneumonia among COPD patients using inhaled corticosteroids and long-acting bronchodilators.

AIM: To assess the risk of pneumonia among COPD patients using salmeterol/fluticasone propionate combination inhalers (SFC), inhaled corticosteroids (ICS), or long-acting beta-agonists (LABA), alone or in combination, compared to those using only short-acting bronchodilators (SABD). METHOD: The study population comprised 5245 individuals using inhaled treatment for COPD, identified from the databases of three large regional managed care organisations from different parts of the USA. Longitudinally-collected administrative data were obtained on their clinical histories and treatments. Nested case-control methods were used to calculate adjusted odds ratios (OR) for the risk of pneumonia while on therapy. RESULTS: 2154 patients had at least one diagnosed case of pneumonia between 1st September 2001 and 31st August 2003. Relative to SABD, the only treatment associated with a non-significant increased risk of pneumonia was ICS used alone (OR=1.29; 95%CI: 0.96-1.73; p=0.09). Users of LABA alone (OR=0.92; 95%CI: 0.69-1.22) or SFC (OR=1.03; 95%CI: 0.74-1.42) had no increased risk for pneumonia relative to SABD. Advanced age and severity of lung disease were strongly associated with increased risk for pneumonia. CONCLUSION: Treatment with ICS or an ICS/LABA combination inhaler was not associated with a significantly increased risk of developing pneumonia.

The role of combination inhaled corticosteroid/long-acting beta-agonist therapy in COPD management.

Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death, affects an estimated 24 million Americans, and accounts for over ten million physician and emergency department (ED) visits and hospitalisations each year. The diagnosis and management of COPD falls largely to primary care practitioners. Previously, COPD management options were limited, but newer treatments have been shown to slow lung deterioration, reduce symptoms and preserve quality of life. Combination therapy with an inhaled corticosteroid and a long-acting beta2-agonist (ICS/LABA) is an effective therapy for COPD that, compared to other therapies, has been shown to reduce exacerbations, hospitalisations, ED visits and health care costs. This review focuses on the role of combination ICS/LABA therapy in managing COPD, including indications, potential benefits and considerations that affect therapy decisions.

Budesonide/formoterol therapy: effective and appropriate use in asthma and chronic obstructive pulmonary disease.

Aim: Quality, real-world comparative effectiveness (CE) studies of asthma and chronic obstructive pulmonary disease therapy efficacy are scarce. We identified and evaluated peer-reviewed CE and appropriate-use evaluations of budesonide/formoterol combination (BFC) maintenance therapy. Materials & methods: Analyses were limited to retrospective, real-world utilization studies of BFC delivered by pressurized metered-dose inhalers. Results: In a CE study of BFC versus fluticasone/salmeterol combinations (FSC) in asthma, BFC users had fewer total exacerbations. In appropriate-use studies of asthma treatment, BFC patients were consistently more likely to meet treatment escalation recommendations. BFC comparisons with FSC or tiotropium for chronic obstructive pulmonary disease found differences in exacerbation rates and rescue inhaler use. Conclusion: We found available, good quality BFC CE and appropriate-use articles; however, all had limitations.

Comparative Causal Analysis of the Effects of Long-Acting Muscarinic Antagonist Versus No Long-Acting Bronchodilator Use on Readmission or Mortality After Hospitalization for Chronic Obstructive Pulmonary Disease.

BACKGROUND: Retrospective observational studies may provide real-world evidence about long-acting muscarinic receptor antagonist (LAMA) effectiveness in reducing mortality or COPD-related readmission risk after a COPD hospitalization. Causal inference and competing risk statistical procedures aid in managing confounding and competing outcome events that complicate retrospective analyses. OBJECTIVE: To compare COPD-related readmission and mortality risk among patients receiving a LAMA versus patients receiving no long-acting bronchodilator ("no LABD") within 30 days post-discharge. METHODS: This retrospective observational analysis of patients (aged ≥ 40 years) hospitalized for COPD used claims data (years 2004-2012). Events occurring during the period from 31 days through 12 months post-discharge were compared. The hazard ratio (HR) for the combined outcome of COPD-related readmission or mortality was estimated using Cox regression. Confounding was addressed using inverse probability of treatment weighting (IPTW). The competing risk of non-COPD-related readmission was considered. RESULTS: 10,405 COPD patients were included (LAMA = 751, no LABD = 9654). IPTW achieved a balanced sample (10,518 LAMA, 10,405 no LABD). Unweighted HR (LAMA vs no LABD) for COPD-related readmission or death, adjusted for age, sex, comorbidities, and baseline utilization, was 1.00 [95% confidence interval (CI) 0.84, 1.20]. Weighted (IPTW) adjusted HR was 0.94 (95% CI 0.88, 1.00). Unweighted and weighted HRs further adjusted for competing risk were 0.97 (95% CI 0.82, 1.16) and 0.91 (0.86, 0.98), respectively. CONCLUSIONS: Bias by indication and comorbidities make the measurement of retrospective COPD treatment effectiveness difficult. Using IPTW and additionally considering the competing event risk, LAMA use was associated with a small reduction in risk for COPD-related readmission or death over the period from 31 days to 12 months post-discharge.

Burden of concomitant asthma and COPD in a Medicaid population.

BACKGROUND: Asthma and COPD can significantly affect patients and pose a substantial economic burden for both patients and managed-care plans. This study compares utilization outcomes in patients with asthma, COPD, or co-occurring asthma and COPD in a Medicaid population, and assesses the incremental burden of COPD in patients with asthma. METHODS: We queried medical claims of Medicaid patients aged 40 to 64 years with asthma and/or COPD filed between January 1, 2001, and December 31, 2003, from encounter data. COPD patients were identified based on at least one claim with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) codes 491, 492, 496; and asthma patients were identified on the basis of ICD-9 code 493 as diagnosis. We analyzed annual utilization and cost of hospitalizations, physician, and outpatient services attributable to asthma and/or COPD. RESULTS: The analysis included a total of 3,072 asthma, 3,455 COPD, and 2,604 COPD/asthma patients. COPD/asthma co-occurring disease has higher utilization of any service type than either disease alone. Compared with asthma patients, COPD patients were 16% and 51% more likely to use physician (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.01 to 1.34) and inpatient services (OR, 1.51; 95% CI, 1.31 to 1.74), respectively; and 60% less likely to use outpatient services (OR, 0.40; 95% CI, 0.35 to 0.46). Compared with asthma patients, COPD patients and COPD/asthma co-occurring patients cost 50% (OR, 1.50; 95% CI, 1.3 to 1.74) and five times (OR, 5.25; 95% CI, 4.59 to 6.02) more for total medical services, respectively. CONCLUSION: Our data suggest that patients with COPD and co-occurring COPD/asthma were sicker and used more medical services than asthma patients. The incremental burden of COPD to patients with asthma is significant.

The direct medical costs of undiagnosed chronic obstructive pulmonary disease.

OBJECTIVE: To estimate the costs of undiagnosed chronic obstructive pulmonary disease (COPD) by describing inpatient, outpatient, and pharmacy utilization in the years before and after the diagnosis. METHODS: A total of 6,864 patients who were enrolled in the Lovelace Health Plan for at least 12 months during the study period (January 1, 1999 through December 31, 2004) were identified. The first date that utilization was attributed to COPD was considered the first date of diagnosis. Each COPD case was matched to up to three age- and sex-matched controls. All utilization and direct medical costs during the study period were compiled monthly and compared based on the time before and after the initial diagnosis. RESULTS: Total costs were higher by an average of $1,182 per patient in the 2 years before the initial COPD diagnosis, and $2,489 in the 12 months just before the initial diagnosis, compared to matched controls. Most of the higher cost for undiagnosed COPD was attributable to hospitalizations. Inpatient costs did not increase after the diagnosis was made, but approximately one-third of admissions after the diagnosis were attributed to respiratory disease. Outpatient and pharmacy costs did not differ substantially between cases and matched controls until just a few months before the initial diagnosis, but remained 50% to 100% higher than for controls in the 2 years after diagnosis. CONCLUSIONS: Undiagnosed COPD has a substantial impact on health-care costs and utilization in this integrated managed care system, particularly for hospitalizations.