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Robert A. Wise, MD1 Kenneth R. Chapman, MD2 Benjamin M. Scirica, MD3,4 David A. Schoenfeld, MD4 Deepak L. Bhatt, MD, MPH3,4 Sami Z. Daoud, MD5 Beatriz Seoane, MSc6 Colin Reisner, MD5 Esther Garcia Gil, MD6
Author Affiliations
- Johns Hopkins University School of Medicine, Baltimore, Maryland
- University of Toronto, Ontario, Canada
- Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
- AstraZeneca Research &Development Center, Gaithersburg, Maryland
- AstraZeneca Research & Development Centre, Barcelona, Spain
Address correspondence to:
Robert A. Wise, MD
University School of Medicine
5501 Hopkins Bayview Circle
Baltimore, MD, 21224
Email: rwise@jhmi.edu
Telephone: (410) 550-0546
Fax: (410) 550-2612
Abstract
Introduction: Chronic obstructive pulmonary disease (COPD) is a heterogeneous illness characterized by persistent airflow obstruction and exacerbations. Patients typically experience a decline in lung function, increasingly impaired health-related quality of life, and high mortality. Poor lung function and exacerbations are associated with an increased risk of cardiovascular (CV) and cerebrovascular events, and approximately 30% of patients with COPD die from CV‑related disease. Treatment with inhaled long-acting bronchodilators, such as long-acting muscarinic antagonists (LAMAs), is recommended; however, some studies have suggested that LAMAs may increase the risk of CV events. As patients with CV and cerebrovascular conditions are often excluded from clinical trials, an evaluation of the safety of COPD treatments in an at-risk population is vital. Aclidinium bromide is a LAMA approved for the long-term maintenance treatment of COPD.
Methods and Objectives: The Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group Aclidinium Bromide on Long-Term Cardiovascular Safety and COPD Exacerbations in PatieNTs with Moderate to Very Severe COPD (ASCENT COPD) study (NCT01966107) is being conducted at 500 sites in the United States and Canada. The primary objectives are to evaluate the long-term effects of twice-daily aclidinium bromide 400 µg on CV safety and exacerbations in patients with moderate to very severe COPD with a history of cerebrovascular, coronary, or peripheral artery disease, or the presence of ≥2 atherothrombotic risk factors. The primary safety and efficacy variables are time to first major adverse CV event (MACE) (on-study analysis) and rate of moderate to severe COPD exacerbations during the first year of treatment (on-treatment analysis), respectively. The study will be terminated after approximately 122 MACE have occurred.
Citation
Citation: Wise RA, Chapman KR, Scirica BM, et al. Long-term evaluation of the effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with moderate to very severe COPD: Rationale and design of the ascent COPD study. Chronic Obstr Pulm Dis. 2018; 5(1): 5-15. doi: http://dx.doi.org/10.15326/jcopdf.5.1.2017.0149
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Shawn P. E. Nishi, MD1 Matthew Maslonka, MD2 Wei Zhang, MS1 Yong-Fang Kuo, PhD3 Gulshan Sharma, MD, MPH1,2
Author Affiliations
- Division of Pulmonary, Critical Care & Sleep Medicine, University of Texas Medical Branch, Galveston
- Department of Internal Medicine, University of Texas Medical Branch, Galveston
- Sealy Center on Aging, University of Texas Medical Branch, Galveston
Address correspondence to:
Shawn P.E. Nishi, MD
Division of Pulmonary, Critical Care & Sleep Medicine
University of Texas Medical Branch
301 University Blvd
Galveston, TX 77555-0561
Email: spnishi@utmb.edu
Telephone: (409)772-2436
Abstract
Background: Maintenance medications provide symptomatic relief, improve lung function and reduce the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Despite their proven benefits, limited information exists on maintenance medication use and adherence among users.
Objective: We examined the patterns and factors associated with the receipt of and adherence to maintenance medication in individuals with COPD.
Methods: A retrospective cross-sectional study of 5% of Medicare beneficiaries enrolled in Parts A, B and D with COPD who received maintenance medication from 2008 to 2013 was conducted. Maintenance medication includes: inhaled corticosteroids (ICSs), long-acting beta2- agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) alone or in combination. We examined the proportion of beneficiaries with COPD who had at least one prescription filled for maintenance medication. Among users of maintenance medications, we also examined adherence, defined as proportion of days covered (PDC) ≥80% over the year from the first maintenance medication prescription fill date.
Results: Overall, maintenance medication (LAMAs, LABAs, ICSs and/or LABA/ICS) use increased from 67.8% in 2008 to 72.1% in 2013. The increase is related to increases in use of LABA/ICS, which rose from 41.1% in 2008 to 49.6% in 2013. Factors associated with receipt of maintenance medication include female gender, recent COPD hospitalization (odds ratio [OR] 1.63; 95% confidence interval [CI] 1.54-1.73), oxygen therapy (OR 1.74 95% CI, 1.68-1.81), dual eligibility status (OR 1.45; 95% CI 1.39-1.51), higher education level and evaluation by a pulmonary provider (OR 1.88; 95% CI 1.81-1.96). The overall adherence among maintenance medication users remained flat. The most important factor associated with adherence was dual eligibility status (OR, 1.67; 95% CI: 1.59-1.75).
Conclusions: Receipt of maintenance medications increased during the study period and was higher in those with dual eligibility. Overall, adherence to maintenance medications was suboptimal and remained unchanged.
Citation
Citation: Nishi SPE, Maslonka M, Zhang W, Kuo Y-F, Sharma G. Pattern and adherence to maintenance medication use in Medicare beneficiaries with chronic obstructive pulmonary disease: 2008-2013. Chronic Obstr Pulm Dis. 2018; 5(1): 16-26. doi: http://dx.doi.org/10.15326/jcopdf.5.1.2017.0153
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Lindsey T. Murray, PhD1 Nancy K. Leidy, PhD1
Author Affiliations
- Evidera, Bethesda, Maryland
Address correspondence to:
Lindsey Murray, PhD
7101 Wisconsin Avenue
Suite 1400
Bethesda, MD 20814
Phone: 301-654-9729
email: lindsey.murray@evidera.com
Abstract
Background: This study examined the short-term effects of symptom-defined exacerbation recovery on health status and pulmonary function in moderate to severe chronic obstructive pulmonary disease (COPD) patients.
Methods: Secondary analyses of pooled data from two 12-week Phase II international, randomized controlled trials using the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) to identify symptom-defined exacerbations were conducted. Recovery was categorized as recovered, unrecovered (persistent worsening), or censored. Multiple regression analyses were used to test the effect of recovery status on change in the St George’s Respiratory Questionnaire (SGRQ) and forced expiratory volume in 1 second (FEV1) from baseline to Week 12. Evaluating Respiratory Symptom scale (E-RS) scores were used to evaluate change in stable-state respiratory symptoms from baseline to Week 12.
Results: Of 1346 eligible patients, 414 (31%) experienced ≥1 symptom-defined exacerbation; 260 patients recovered from their events, 80 experienced an unrecovered event (persistent worsening), 74 patients had only censored events (excluded). Groups were similar at baseline, with the recovered group reporting significantly worse symptoms (p<0.01). Recovery group and baseline SGRQ were significant predictors of change in health status over 12 weeks (p=0.04; p<0.01); no effects were observed for lung function. Significant between-group differences in change in respiratory symptom severity from baseline to Week 12 were observed (p<0.01), with the persistent worsening group experiencing clinically meaningful deterioration in breathlessness and chest symptoms.
Conclusions: Results suggest some patients have difficulty recovering from symptom-defined exacerbations, leading to a deterioration in health status, dyspnea, and chest symptoms without short-term effects on lung function. Further study of symptom-defined exacerbation recovery and health outcomes is warranted.
Citation
Citation: Murray LT, Leidy NK. The short-term impact of symptom-defined COPD exacerbation recovery on health status and lung function. Chronic Obstr Pulm Dis. 2018; 5(1): 27-37. doi: http://dx.doi.org/10.15326/jcopdf.5.1.2017.0166
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Todd W. Chapin, PharmD, BCPS1 Michael A. Mann, MPH2 Gary L. Brown, RRT, FAARC3 Traci L. Leitheiser, BS, RRT, CTTS3 Becky Anderson, RRT3 David D. Leedahl, PharmD, BCPS-AQ ID, BCCCP1
Author Affiliations
- Pharmacy Services, Sanford Health, Fargo, North Dakota
- North Dakota State University College of Health Professions, Fargo
- Respiratory Care Services, Sanford Health, Fargo, North Dakota
Abstract
Background: Bronchodilator therapy is a foundation of chronic obstructive pulmonary disease (COPD) exacerbation treatment. Although international guidelines recommend short-acting formulations given multiple times per day, long-acting formulations have not been adequately evaluated. The objective of our study was to determine the effectiveness of umeclidinium-vilanterol (UME/VIL), long-acting beta2-agonist/long-acting muscarinic antagonist (LABA/LAMA) as a once-daily alternative for treating COPD exacerbations in hospitalized patients.
Methods: In this retrospective sequential period analysis, we reviewed electronic medical records of patients hospitalized for COPD exacerbations before (September 1, 2015 to February 29, 2016) and after (April 1, 2016 to September 30, 2016) incorporation of UME/VIL into our standard COPD protocol. Before implementation, patients received a daily anticholinergic plus twice-daily long-acting beta2-agonist therapy (tiotropium plus formoterol, n=65). After implementation, UME/VIL replaced the previous regimen (n=58). No other changes were made to the COPD protocol. The primary outcome was 30-day hospital readmission rate. Hospital length of stay, 30-day mortality, and cost of care were analyzed as secondary outcomes.
Results: A trend toward increased 30-day readmission rates in the post-intervention group (24.1% versus 10.8%, p=0.049) was no longer statistically significant after adjustment for severity of illness (based on case-mix index) and complications or comorbidities based on diagnosis-related group codes (adjusted odds ratio: 2.499; 95% confidence interval: 0.916-7.380; p=0.074).
Conclusion: After adjustment for potential confounders,the implementation of a LABA/LAMA combination product was not statistically associated with an increased 30-day readmission rate but was associated with lower cost of care.
Citation
Citation: Chapin TW, Mann MA, Brown GL, Leitheiser TL, Anderson B, Leedahl DD. Effectiveness of umeclidinium-vilanterol for protocolized management of chronic obstructive pulmonary disease exacerbation in hospitalized patients: A sequential period analysis. Chronic Obstr Pulm Dis. 2018; 5(1): 38-45. doi: http://dx.doi.org/10.15326/jcopdf.5.1.2017.0163
Keywords
COPD, chronic obstructive pulmonary disease, exacerbations, tiotropium, bronchodilator, length of stay, umeclidinium, vilanterol, formoterol, hospital readmission, treatment protocol, respiratory therapy
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Madeline A. Morris, MPH1 Sean R. Jacobson, MS1 Gregory L. Kinney, PhD, MPH2 Donald P. Tashkin, MD3 Prescott G. Woodruff, MD, MPH4 Eric A. Hoffman, PhD5 Richard E. Kanner, MD, MPH6,7 Christopher B. Cooper, MD3 M. Brad Drummond, MD, MHS8 R. Graham Barr, MD, DrPH, MPH9 Elizabeth C. Oelsner, MD9 Barry J. Make, MD1 MeiLan K. Han, MD, MS10 Nadia N. Hansel, MD, MPH11 Wanda K. O’Neal, PhD8 Russell P. Bowler, MD, PhD1
Author Affiliations
- National Jewish Health, Denver, Colorado
- Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora
- Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine, University of California at Los Angeles
- Division of Pulmonary, Critical Care, Sleep and Allergy, Department of Medicine and Cardiovascular Research Institute, University of California San Francisco, School of Medicine, San Francisco
- Departments of Radiology, Medicine and Biomedical Engineering, University of Iowa, Iowa City
- University of Utah Health Sciences Center, Salt Lake City
- Department of Biostatics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora
- Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill
- Columbia University, Division of General Medicine, New York, New York
- University Michigan Health System, Ann Arbor
- Johns Hopkins University, Baltimore, Maryland
Address correspondence to:
Russell Bowler & Madeline A. Morris
Department of Medicine, Division of Pulmonary Medicine
National Jewish Health
Denver, Colorado
Telephone: (303)270-2014
Emails: bowler@njhealth.org mamorris8@gmail.com
Abstract
Background: Marijuana is often smoked via a filterless cigarette and contains similar chemical makeup as smoked tobacco. There are few publications describing usage patterns and respiratory risks in older adults or in those with chronic obstructive pulmonary disease (COPD).
Methods: A cross-sectional analysis of current and former tobacco smokers from the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS) study assessed associations between marijuana use and pulmonary outcomes. Marijuana use was defined as never, former (use over 30 days ago), or current (use within 30 days). Respiratory health was assessed using quantitative high-resolution computed tomography (HRCT) scans, pulmonary function tests and questionnaire responses about respiratory symptoms.
Results: Of the total2304 participants, 1130 (49%) never, 982 (43%) former, and 192 (8%) current marijuana users were included. Neither current nor former marijuana use was associated with increased odds of wheeze (odds ratio [OR] 0.87, OR 0.97), cough (OR 1.22; OR 0.93) or chronic bronchitis (OR 0.87; OR 1.00) when compared to never users. Current and former marijuana users had lower quantitative emphysema (P=0.004, P=0.03), higher percent predicted forced expiratory volume in 1 second (FEV1%) (P<0.001, P<0.001), and percent predicted forced vital capacity (FVC%) (p<0.001, P<0.001). Current marijuana users exhibited higher total tissue volume (P=0.003) while former users had higher air trapping (P<0.001) when compared to never marijuana users.
Conclusions: Marijuana use was found to have little to no association with poor pulmonary health in older current and former tobacco smokers after adjusting for covariates. Higher forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) was observed among current marijuana users. However, higher joint years was associated with more chronic bronchitis symptoms (e.g., wheeze), and this study cannot determine if long-term heavy marijuana smoking in the absence of tobacco smoking is associated with lung symptoms, airflow obstruction, or emphysema, particularly in those who have never smoked tobacco cigarettes.
Citation
Citation: Morris MA, Jacobson SR, Kinney GL, et al. Marijuana use associations with pulmonary symptoms and function in tobacco smokers enrolled in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS). Chronic Obstr Pulm Dis. 2018; 5(1): 46-56. doi: http://dx.doi.org/10.15326/jcopdf.5.1.2017.0141
Keywords
emphysema, chronic obstructive pulmonary disease, Lung, smoking, marijuana, tobacco, epidemiology, pulmonary, cross-sectional, respiratory, forced expiratory volume, forced vital capacity, computed tomography scan
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Tyler Scholl, PharmD1 Tyree H. Kiser, PharmD1 Sheryl F. Vondracek, PharmD1
Author Affiliations
- University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora
Address correspondence to:
Sheryl F. Vondracek, PharmD
University of Colorado
Skaggs School of Pharmacy and Pharmaceutical Sciences
12850 E. Montview Blvd. C238
Aurora, CO 80045
Phone: (303) 724 2638
Email: sheryl.vondracek@ucdenver.edu
Abstract
Background: Chronic obstructive pulmonary disease (COPD) and pneumonia are leading causes of morbidity and mortality and are frequently comorbid. Studies of systemic corticosteroids in pneumonia have shown conflicting outcomes, whereas studies in acute exacerbations of COPD (AECOPD) have shown significant benefits. No studies have evaluated systemic corticosteroids in patients with both an AECOPD and pneumonia.
Purpose: To evaluate the use of systemic corticosteroids in patients with both an AECOPD and pneumonia.
Patients and Methods: Patients with a diagnosis of both COPD or obstructive chronic bronchitis with exacerbation and pneumonia admitted to the University of Colorado Hospital between July 1, 2012 and May 20, 2016 were retrospectively evaluated. Patients who received systemic corticosteroids were compared to those that did not. The primary outcome was length of hospital stay (LOHS). Secondary outcomes were in-hospital treatment failure, a composite of intensive care unit (ICU) admission, ventilation, and escalation of steroid therapy, 30-day AECOPD or pneumonia readmission, and 30-day mortality.
Results: A total of 138 patients were included-- 89 in the steroid group and 49 in the non-steroid group. No significant differences in baseline characteristic were noted. No difference was seen in mean LOHS (4.7±3.2 versus 4.2±2.1 days, p=0.27), in-hospital treatment failure (7% versus 4%, p=0.72), 30-day readmission or 30-day mortality between the steroid and non-steroid groups, respectively. There was a difference in mean LOHS for patients with severe pneumonia between the steroid and non-steroid groups (6.0±4.0 versus 4.3±1.8; p=0.03).
Conclusions: This study suggests that systemic corticosteroids may not provide a clinical benefit to patients with an AECOPD and pneumonia.
Citation
Citation: Scholl T, Kiser TH, Vondracek SF.Evaluation of systemic corticosteroids in patients with an acute exacerbation of COPD and a diagnosis of pneumonia. Chronic Obstr Pulm Dis. 2018; 5(1): 57-65. doi: http://dx.doi.org/10.15326/jcopdf.5.1.2017.0157
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