AT CHEST 2016
LOS ANGELES – Indacaterol/glycopyrronium was superior to salmeterol/fluticasone at reducing the risk and rate of moderate to severe exacerbations in chronic obstructive pulmonary disease (COPD) patients with more than one or zero to one exacerbations in the previous year, results from an indirect comparison showed.
“Acute exacerbations of COPD are associated with accelerated decline in lung function and increased mortality,” Kenneth R. Chapman, MD, said at the annual meeting of the American College of Chest Physicians. “Current GOLD [Global Initiative for Chronic Obstructive Lung Disease] strategy recommends LABA/ICS [long-acting beta-agonist/inhaled corticosteroid] combination, and/or LAMA [long-acting muscarinic antagonist] as the first-line treatment, and LABA/LAMA as an alternative treatment for COPD patients at a high risk of exacerbations.”
In an effort to examine the reduction in moderate or severe exacerbations in COPD patients taking indacaterol/glycopyrronium (a combination of a LABA bronchodilator and a LAMA bronchodilator) or salmeterol/fluticasone (a LABA and inhaled glucocorticoid combination), researchers compared results from the FLAME and LANTERN trials. The FLAME study evaluated the rate and risk of exacerbations with indacaterol/glycopyrronium versus salmeterol/fluticasone in 3,362 moderate to very severe COPD patients with at least one exacerbation in the previous year (N Engl J Med. 2016;374[23]:2222-34).The LANTERN study compared the efficacy and safety of indacaterol/glycopyrronium versus salmeterol/fluticasone in 744 moderate to very severe COPD patients with 0-1 exacerbation in the previous year (Int J Chron Obstruct Pulmon Dis. 2015;10:1015-26).
Dr. Chapman, professor of medicine at the University of Toronto, reported that in the FLAME study, which was 52 weeks long, indacaterol/glycopyrronium significantly reduced the annualized rate of moderate or severe COPD exacerbations in patients who had one or more exacerbation in the previous year (a rate ratio of 0.83; P less than 0.001), which translated in to a clinically meaningful 17% reduction, compared with their counterparts taking salmeterol/fluticasone. In the LANTERN study, which was 26 weeks long, indacaterol/glycopyrronium also significantly reduced the annualized rate of patients who had 0-1 exacerbation in the previous year, compared with those taking salmeterol/fluticasone (RR, 0.69; P = .048).
In FLAME, indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 22% risk reduction, compared with salmeterol/fluticasone (hazard ratio, 0.78; P less than .001). Similar findings were observed in LANTERN; indacaterol/glycopyrronium significantly delayed the time to first moderate or severe exacerbation, with a clinically meaningful 35% risk reduction, compared with salmeterol/fluticasone (HR, 0.65; P less than .028).
“These results suggest that LABA/LAMA combinations such as indacaterol/glycopyrronium can be considered as a preferred treatment option in the management of COPD patients, irrespective of exacerbation history,” Dr. Chapman said.He went on to note that in FLAME, the incidence of pneumonia was 3.2% in the indacaterol/glycopyrronium group, compared with 4.8% in the salmeterol/fluticasone group P = .02). In LANTERN, the incidence of pneumonia was 0.8% in the indacaterol/glycopyrronium group, compared with 2.7% in the salmeterol/fluticasone group. Finally, in FLAME, the incidence of oral candidiasis was 1.2% in the indacaterol/glycopyrronium group, compared with 4.2% in the salmeterol/fluticasone group (P less than .001). In LANTERN, the respective values were 0% and 0.3%.
Dr. Chapman reported having numerous financial disclosures, including receiving consulting fees and research grants from Novartis.