Prescribing pathways to triple therapy in patients with chronic obstructive pulmonary disease in the United States – ScienceOpen
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      Prescribing pathways to triple therapy in patients with chronic obstructive pulmonary disease in the United States

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          Abstract

          Background:

          Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend triple therapy (TT) for chronic obstructive pulmonary disease (COPD) patients based on severity. TT utilization by severity is infrequently studied in real-world settings and may deviate significantly from current clinical recommendations. This study describes prescribing pathways to TT among patients with COPD in the United States.

          Methods:

          This study analyzed Geisinger Health System electronic medical records from 1 January 2004 to 30 November 2016. Two retrospective cohorts of COPD patients were included: (1) incident COPD, and (2) incident TT users. COPD treatment patterns, including time to TT, were summarized. Time to TT was estimated using Kaplan–Meier methods. Predictors of the relative hazard for TT among incident COPD patients were estimated using Cox proportional hazards regressions.

          Results:

          Incident COPD and TT cohorts included 57,141 and 8173 patients, respectively. TT was used by 9.6% of incident COPD patients. In the year before TT, 34.3% of incident TT patients received treatment combinations recommended before TT according to GOLD recommendations, which mainly included: long-acting muscarinic antagonists (LAMAs), long-acting beta agonists (LABAs) + LAMAs, and inhaled corticosteroids  + LABAs. Among incident TT patients, median time from COPD diagnosis to TT exceeded 2 years. The hazard for TT over time was associated with lower forced expiratory volume in 1 s values, more frequent exacerbations, current/previous smoking, and comorbid lung conditions such as pulmonary vascular disease, acute respiratory failure, and lung cancer. About 15–20% of the incident TT patients stepped down to a one- or two-drug regimen. Median time to TT discontinuation or step-down were 2 and 9 months, respectively.

          Conclusion:

          The study has revealed discrepancies in the treatment of COPD patients between GOLD guidelines and actual clinical practices in the United States. Pathways to TT differed from recommended therapy regimes. Further studies are needed to understand barriers to the use of guideline-recommended TTs by healthcare providers.

          The reviews of this paper are available via the supplemental material section.

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          Most cited references12

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          Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries.

          With advances in the effectiveness of treatment and disease management, the contribution of chronic comorbid diseases (comorbidities) found within the Charlson comorbidity index to mortality is likely to have changed since development of the index in 1984. The authors reevaluated the Charlson index and reassigned weights to each condition by identifying and following patients to observe mortality within 1 year after hospital discharge. They applied the updated index and weights to hospital discharge data from 6 countries and tested for their ability to predict in-hospital mortality. Compared with the original Charlson weights, weights generated from the Calgary, Alberta, Canada, data (2004) were 0 for 5 comorbidities, decreased for 3 comorbidities, increased for 4 comorbidities, and did not change for 5 comorbidities. The C statistics for discriminating in-hospital mortality between the new score generated from the 12 comorbidities and the Charlson score were 0.825 (new) and 0.808 (old), respectively, in Australian data (2008), 0.828 and 0.825 in Canadian data (2008), 0.878 and 0.882 in French data (2004), 0.727 and 0.723 in Japanese data (2008), 0.831 and 0.836 in New Zealand data (2008), and 0.869 and 0.876 in Swiss data (2008). The updated index of 12 comorbidities showed good-to-excellent discrimination in predicting in-hospital mortality in data from 6 countries and may be more appropriate for use with more recent administrative data. © The Author 2011. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved.
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            The clinical and economic burden of chronic obstructive pulmonary disease in the USA

            Chronic obstructive pulmonary disease (COPD) is the third most common cause of death in the USA. In 2010, the cost of COPD in the USA was projected to be approximately US$50 billion, which includes $20 billion in indirect costs and $30 billion in direct health care expenditures. These costs can be expected to continue to rise with this progressive disease. Costs increase with increasing severity of disease, and hospital stays account for the majority of these costs. Patients are diagnosed with COPD following a multifactorial assessment that includes spirometry, clinical presentation, symptomatology, and risk factors. Smoking cessation interventions are the most influential factor in COPD management. The primary goal of chronic COPD management is stabilization of chronic disease and prevention of acute exacerbations. Bronchodilators are the mainstay of COPD therapy. Patients with few symptoms and low exacerbation risk should be treated with a short-acting bronchodilator as needed for breathlessness. Progression of symptoms, as well as possible decline in forced expiratory volume in the first second of expiration (FEV1), warrant the use of long-acting bronchodilators. For patients with frequent exacerbations with or without consistent symptoms, inhaled corticosteroids should be considered in addition to a long-acting beta2-agonist (LABA) or long-acting muscarinic antagonist (LAMA) and may even consist of “triple therapy” with all three agents with more severe disease. Phosphodiesterase-4 inhibitors may be an option in patients with frequent exacerbations and symptoms of chronic bronchitis. In addition to a variety of novel ultra-LABAs, LAMAs and combination bronchodilator and inhaled corticosteroid (ICS) therapies, other bronchodilators with a variety of mechanisms are also being considered, to expand therapeutic options for the treatment of COPD. With more than 50 new medications in the pipeline for the treatment of COPD, optimal management will continue to evolve and grow more complex as benefits of therapy are balanced with the limitations and needs of each patient.
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              Under- and over-diagnosis of COPD: a global perspective

              Globally, chronic obstructive pulmonary disease (COPD) is the fourth major cause of mortality and morbidity and projected to rise to third within a decade as our efforts to prevent, identify, diagnose and treat patients at a global population level have been insufficient. The European Respiratory Society and American Thoracic Society, along with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document, have highlighted key pathological risk factors and suggested clinical treatment strategies in order to reduce the mortality and morbidity associated with COPD. This review focuses solely on issues related to the under- and over-diagnosis of COPD across the main geographical regions of the world and highlights some of the associated risk factors. Prevalence of COPD obtained mainly from epidemiological studies varies greatly depending on the clinical and spirometric criteria used to diagnose COPD, i.e. forced expiratory volume in 1 s to forced vital capacity ratio <0.7 or 5% below the lower limit of normal, and this subsequently affects the rates of under- and over-diagnosis. Although under-utilisation of spirometry is the major reason, additional factors such as exposure to airborne pollutants, educational level, age of patients and language barriers have been widely identified as other potential risk factors. Co-existent diseases, such as asthma, bronchiectasis, heart failure and previously treated tuberculosis, are reported to be the other determinants of under- and over-diagnosis of COPD. Key points Globally, there is large variation in the prevalence of COPD, with 10–95% under-diagnosis and 5–60% over-diagnosis (table 1) due to differences in the definition of diagnosis used, and the unavailability of spirometry in rural areas of low- and middle-income countries where the prevalence of COPD is likely to be high. In order to be diagnosed with COPD, patients must have a combination of symptoms with irreversible airflow obstruction defined by a post-bronchodilator FEV1/FVC ratio of <0.7 or below the fifth centile of the lower limit of normal (LLN), and with a history of significant exposure to a risk factor. Repeat spirometry is recommended if the ratio is between 0.6 and 0.8. Not performing spirometry is the strongest predictor for an incorrect diagnosis of COPD; however, additional factors, such as age, gender, ethnicity, self-perception of symptoms, co-existent asthma, and educational awareness of risk factor by patients and their physician, are also important. COPD can be associated with inhalation of noxious particles other than smoking tobacco. Educational aims To summarise the global prevalence of over- and under-diagnosis of COPD. To highlight the risk factors associated with the under- and over-diagnosis of COPD. To update readers on the key changes in the recent progress made regarding the correct diagnosis of COPD.
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                Author and article information

                Contributors
                Journal
                Ther Adv Respir Dis
                Ther Adv Respir Dis
                TAR
                sptar
                Therapeutic Advances in Respiratory Disease
                SAGE Publications (Sage UK: London, England )
                1753-4658
                1753-4666
                18 April 2021
                Jan-Dec 2021
                : 15
                : 17534666211001018
                Affiliations
                [1-17534666211001018]Independent, Sarajevo, Bosnia and Herzegovina
                [2-17534666211001018]Evidera Inc, Waltham, MD, USA
                [3-17534666211001018]AstraZeneca plc, Gothenburg, Sweden
                [4-17534666211001018]BioPharmaceuticals Medical, AstraZeneca, KC6 SE-431 83 Mölndal, Gothenburg, Sweden
                Author notes
                Author information
                https://orcid.org/0000-0001-8351-0265
                Article
                10.1177_17534666211001018
                10.1177/17534666211001018
                8058794
                33866875
                29bebe35-d89c-42c4-8900-6b108689cec0
                © The Author(s), 2021

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 22 January 2021
                : 8 February 2021
                Funding
                Funded by: AstraZeneca, FundRef https://doi.org/10.13039/100004325;
                Categories
                Original Research
                Custom metadata
                January-December 2021
                ts1

                chronic obstructive pulmonary disease,gold guidelines,prescribing pathways,retrospective cohort study,triple therapy

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