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Introduction Several dual bronchodilator fixed-dose inhaler medications were recently approved for the treatment of chronic obstructive pulmonary disease (COPD). These products combine a long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA). In clinical trials, the separate mechanisms of the bronchodilators resulted in improved lung function. COPD treatment guidelines currently recommend combination LABA/LAMA as alternative therapy to combination LABA/inhaled corticosteroid (ICS). Evidence is limited on the comparative effectiveness of LABA/LAMA and LABA/ICS in COPD. The objective of this study was to compare real-world COPD exacerbation rates among patients treated with LABA/LAMA with those treated with LABA/ICS. Methods This was a retrospective observational study of COPD patients in the United States treated with LABA/LAMA or LABA/ICS combination. Insurance claims from January 1, 2004, through December 31, 2014, were used as the data source. Patients were required to have greater than one prescription filled for the combination medications, and they were followed from 30 days after drug initiation. Individuals were censored if they discontinued a study medication, initiated medication from the opposite cohort (LAMA or ICS), lost enrollment eligibility, or at the study period end. Exacerbation rates were compared using Poisson regression. Results There were 5384 patients in the LABA/LAMA cohort and 473,388 patients in the LABA/ICS cohort. The LABA/LAMA cohort was older, had more comorbidities, and more severe COPD. Unadjusted annual exacerbation rates were 2.87 events per person-year (standard deviation [SD] 5.14) in the LABA/LAMA cohort and 1.68 (SD 9.82) in the LABA/ICS cohort. The adjusted incidence rate ratio was 0.98 (95% confidence interval 0.95-1.01) for LABA/LAMA compared with LABA/ICS. Conclusions The LABA/LAMA combination had similar effectiveness to LABA/ICS as measured by exacerbation rates in COPD patients. As a result, characteristics other than effectiveness, such as symptom control, cost, patient preferences, and adverse events, may be important in selecting between the two regimens. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The Global Initiative for Chronic Obstructive Lung Disease ( GOLD) guidelines are well-known international clinical practice guidelines for chronic obstructive pulmonary disease ( COPD). The objective of this study was to examine how treatment recommendations and the quality of supporting evidence for pharmacologic management of stable COPD have evolved since the initial guidance issued in 2001. Methods Recommendations in the 2001 and 2011 GOLD guidelines, along with the evidence grades (i.e. A, B, C, D), were identified and abstracted. We determined the distribution and evolution of recommendations across levels of evidence and treatment categories over time. Results There were 35 and 54 recommendations identified in the 2001 and 2011 guidelines, respectively. Twenty-six recommendations were common to the 2001 and 2011 guidelines, with eight having the same evidence grade in both versions and three having a grade change (one upgraded and two downgraded). Twenty-eight new recommendations were added in 2011. Bronchodilators, glucocorticosteroids, and phosphodiesterase-4 inhibitors are the classes of pharmacologic treatment with the most prominent changes regarding emerging evidence and the number of recommendations. Approximately 45% of the graded recommendations were supported by well-designed randomized controlled trials, i.e. grade A. Conclusions The GOLD guideline recommendations have changed considerably over the past 11 years, which reflects a dynamic evidence base and perhaps a change in the way guideline developers view the evidence to inform recommendations. Given the large number of recommendations with lower grade levels, there continues to be substantial opportunity to inform gaps in the evidence base with high-quality studies. [ABSTRACT FROM AUTHOR]