You walk into your office to see, once again, Mr. Jones, at 64-year-old male who suffers from chronic obstructive pulmonary disorder (COPD). Mr. Jones is recovering from a recent visit to the ED due to his third COPD exacerbation event this year. He’s frustrated with his recurrent COPD exacerbations, and wants to know if his current treatment plan really is the best way to prevent them.
Treatment guidelines for prevention of COPD exacerbations recommend either inhaled corticosteroids (ICS) with long-acting β2-agonists (LABA) or an inhaled long-acting muscarinic antagonist (LAMA). However, the dual bronchodilator regimen of LABA/LAMA has yet to be tested in comparison to the ICS/LABA combination. To address the efficacy of this treatment plan, Wedzicha et al report the results of the FLAME trial in this week’s issue of NEJM. The authors enrolled over 3000 patients across 43 countries in this multicenter, randomized, double-blind, non-inferiority study. In terms of their primary endpoint, the LABA/LAMA regimen, indacaterol/glycopyrronium or IND/GLY, reached non-inferiority in comparison to the ICS/LABA regimen, salmaterol/fluticasone or SFC. In addition, IND/GLY showed superiority in reducing the annual rate of exacerbations in comparison to SFC, and prolonged time to first moderate or severe exacerbation. Although high blood eosinophil count had previously been suggested to be a biomarker that indicates better response to ICS/LABA treatment, blood eosinophilia, above or below 2%, did not impact the outcome of this trial. There was no detectable increase in adverse events with IND/GLY vs. SFC in fact there were fewer episodes of pneumonia, 3.2% in the IND/GLY group vs. 4.8% in the SFC group, P,0.02.
From these outcomes, the authors conclude that IND/GLY appears more effective at reducing exacerbations in comparison to SFC. In an accompanying editorial, however, James Donohue, MD, cautions against immediately switching your patients, like Mr. Jones, to this treatment regimen. He warns that more trials, especially those of longer duration and with patients with more severe co-morbidities are needed.
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Rachel is a fifth-year MD/PhD student at Harvard Medical School. She is originally from Okemos, MI, and graduated from Stanford University in 2011. For her PhD research, she is studying the regulation of cell growth in response to nutrients.