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Observational Study
. 2016 Dec 22:12:73-83.
doi: 10.2147/COPD.S122013. eCollection 2017.

Initiation of triple therapy maintenance treatment among patients with COPD in the US

Jason C Simeone  1 , Rakesh Luthra  2 , Shuchita Kaila  2 , Xiaoyun Pan  1 , Tarun D Bhagnani  1 , Jieruo Liu  1 , Teresa K Wilcox  1
Affiliations
Observational Study

Initiation of triple therapy maintenance treatment among patients with COPD in the US

Jason C Simeone et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Background: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends triple therapy (long-acting muscarinic receptor antagonists, long-acting beta-2 agonists, and inhaled corticosteroids) for patients with only the most severe COPD. Data on the proportion of COPD patients on triple therapy and their characteristics are sparse and dated. Objective 1 of this study was to estimate the proportion of all, and all treated, COPD patients receiving triple therapy. Objective 2 was to characterize those on triple therapy and assess the concordance of triple therapy use with GOLD guidelines.

Patients and methods: This retrospective study used claims from the IMS PharMetrics Plus database from 2009 to 2013. Cohort 1 was selected to assess Objective 1 only; descriptive analyses were conducted in Cohort 2 to answer Objective 2. A validated claims-based algorithm and severity and frequency of exacerbations were used as proxies for COPD severity.

Results: Of all 199,678 patients with COPD in Cohort 1, 7.5% received triple therapy after diagnosis, and 25.5% of all treated patients received triple therapy. In Cohort 2, 30,493 COPD patients (mean age =64.7 years) who initiated triple therapy were identified. Using the claims-based algorithm, 34.5% of Cohort 2 patients were classified as having mild disease (GOLD 1), 40.8% moderate (GOLD 2), 22.5% severe (GOLD 3), and 2.3% very severe (GOLD 4). Using exacerbation severity and frequency, 60.6% of patients were classified as GOLD 1/2 and 39.4% as GOLD 3/4.

Conclusion: In this large US claims database study, one-quarter of all treated COPD patients received triple therapy. Although triple therapy is recommended for the most severe COPD patients, spirometry is infrequently assessed, and a majority of the patients who receive triple therapy may have only mild/moderate disease. Any potential overprescribing of triple therapy may lead to unnecessary costs to the patient and health care system.

Keywords: COPD; epidemiology; retrospective study; severity; triple therapy.

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Conflict of interest statement

Boehringer Ingelheim, Inc. provided the funding for this study. RL and SK are salaried employees of Boehringer Ingelheim. JCS, TDB, JL, and TKW are currently employees of Evidera, which provides consulting and other research services to pharmaceutical, device, and other organizations. In their salaried positions, they work with a variety of companies and organizations and are precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received funding from Boehringer Ingelheim for work on the project and the manuscript. XP was an employee of Evidera during the conduct of this study and the writing of this manuscript; she is currently employed by Sunovion Pharmaceuticals, Marlborough, MA. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Sample selection for Objective 1 (to estimate the proportion of patients with COPD who receive a triple therapy maintenance regimen [LAMA/LABA/ICS]). Notes: IMS PharMetrics Plus database from January 1, 2009 to December 31, 2013. *Defined as ICD-9-CM code for 491.xx (chronic bronchitis), 492.xx (emphysema), or 496.xx (COPD, unspecified) in primary or secondary position. Abbreviations: ICD-9-CM, International Classification of Diseases – Ninth Revision – Clinical Modification; ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic receptor antagonist.
Figure 2
Figure 2
Sample selection for Objective 2 (to describe the demographic and clinical characteristics, and health care resource use of patients with COPD prior to initiation of a triple therapy maintenance regimen [LAMA/LABA/ICS]). Notes: IMS PharMetrics Plus database from January 1, 2009 to December 31, 2013. *Defined as ICD-9-CM code for 491.xx (chronic bronchitis), 492.xx (emphysema), or 496.xx (COPD, unspecified) in primary or secondary position. Abbreviations: ICD-9-CM, International Classification of Diseases – Ninth Revision – Clinical Modification; ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic receptor antagonist.
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