Efficacy and Safety of a Fixed-Dose Combination of Indacaterol and Glycopyrronium for the Treatment of COPD: A Systematic Review

Abstract

<h3>BACKGROUND</h3> COPD guidelines recommend the combined use of inhaled, long-acting β₂-agonists and long-acting muscarinic antagonists if symptoms are not improved by a single agent. This systematic review assessed the efficacy and safety of the fixed-dose combination of the long-acting β₂-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium (QVA149) compared with its monocomponents (glycopyrronium and indacaterol) and tiotropium for the treatment of moderate to severe COPD. <h3>METHODS</h3> This was a systematic review of randomized, placebo-controlled or crossover trials (3-64 weeks). Primary outcomes were trough FEV₁, severe adverse events, and serious cardiovascular events. <h3>RESULTS</h3> Five trials (4,842 patients) were included. Compared with tiotropium, QVA149 showed a significant increase in trough FEV₁ (70 mL; <i>P</i> < .0001) and a decreased use of rescue medication (−0.63 puffs/d; <i>P</i> < .0001). Patients receiving QVA149 had a 19% greater likelihood of experiencing a minimal clinical important difference (MCID) in the number needed to treat for benefit (NNTB) (NNTB = 11) and a 16% greater likelihood of achieving an MCID in the St. George's Respiratory Questionnaire (SGRQ) (NNTB = 11). Similarly, QVA149 vs glycopyrronium showed a significant increase in trough FEV₁ (70 mL; <i>P</i> < .0001), a significant reduction in rescue medication use (−0.59; <i>P</i> < .0001), and a significant increase in the rate of patients achieving an MCID in the SGRQ (NNTB = 12). QVA149 showed similar levels of safety and tolerability to both comparators. It was not possible to perform a pooled analysis of data comparing QVA149 vs indacaterol. <h3>CONCLUSIONS</h3> Once-daily, inhaled QVA149 showed superior efficacy compared with glycopyrronium and the current standard of care, tiotropium, in patients with moderate to severe COPD.