Indacaterol/glycopyrronium versus tiotropium or glycopyrronium in long-acting bronchodilator-naïve COPD patients: A pooled analysis

Respirology. 2020 Apr;25(4):393-400. doi: 10.1111/resp.13651. Epub 2019 Jul 24.

Abstract

Background and objective: Indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily (q.d.) has demonstrated greater improvements in lung function, patient-reported outcomes and lower exacerbation rates versus mono long-acting muscarinic antagonists (LAMA) in chronic obstructive pulmonary disease (COPD) patients. However, data are limited on initial treatment with IND/GLY 110/50 μg q.d. versus mono LAMA in COPD patients, not previously on maintenance treatment with long-acting bronchodilators (LABD).

Methods: A pooled analysis of ARISE, SHINE and SPARK trials was conducted to evaluate the efficacy of IND/GLY 110/50 μg q.d. versus open-label (OL) tiotropium (TIO) 18 μg q.d. and GLY 50 μg q.d. in COPD patients, not on maintenance treatment with LABD at study entry (LABD-naïve). Efficacy was assessed after 24/26 weeks of treatment.

Results: In total, 998 LABD-naïve patients were included (IND/GLY: 353; OL TIO: 328; GLY: 317). Patients treated with IND/GLY 110/50 μg q.d. experienced greater improvements in trough forced expiratory volume in 1 s (FEV1 ) versus OL TIO 18 μg q.d. (least squares mean treatment difference (Δ): 0.086 L) and GLY 50 μg q.d. (Δ: 0.080 L) after 24/26 weeks. Improvements in electronic diary (eDiary) symptom scores, transition dyspnoea index (TDI) focal score, St George's Respiratory Questionnaire (SGRQ) total score and rescue medication use were also greater with IND/GLY versus OL TIO and GLY. Greater proportion of patients achieved minimal clinically important difference in trough FEV1 , TDI and SGRQ with IND/GLY versus OL TIO and GLY.

Conclusion: LABD-naïve patients treated with IND/GLY 110/50 μg q.d. achieved improvements in lung function, daily symptoms, dyspnoea, health-related quality of life and rescue medication use versus those who received single LAMA.

Keywords: bronchodilator-naïve; chronic obstructive pulmonary disease; glycopyrronium; indacaterol-glycopyrronium combination; tiotropium.

Publication types

  • Comparative Study

MeSH terms

  • Adrenergic beta-2 Receptor Agonists / therapeutic use
  • Aged
  • Bronchodilator Agents / therapeutic use
  • Drug Combinations
  • Dyspnea / etiology
  • Dyspnea / physiopathology
  • Female
  • Forced Expiratory Volume
  • Glycopyrrolate / therapeutic use*
  • Humans
  • Indans / therapeutic use*
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Muscarinic Antagonists / therapeutic use
  • Pulmonary Disease, Chronic Obstructive / complications
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Quality of Life
  • Quinolones / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Tiotropium Bromide / therapeutic use*

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Bronchodilator Agents
  • Drug Combinations
  • Indans
  • Muscarinic Antagonists
  • Quinolones
  • indacaterol
  • Glycopyrrolate
  • Tiotropium Bromide