Efficacy and safety of indacaterol in patients with chronic obstructive pulmonary disease aged over 65 years: A pooled analysis

Respir Med. 2017 Jul:128:92-101. doi: 10.1016/j.rmed.2017.05.010. Epub 2017 May 24.

Abstract

Background: Although the prevalence of chronic obstructive pulmonary disease (COPD) increases with age, no specific therapeutic approaches are available till date for the elderly population.

Aim: To assess the efficacy and safety of once-daily indacaterol 150 and 300 μg in elderly patients with moderate to severe COPD.

Methods: Data were pooled from 11 randomized, double-blind, placebo- and active-controlled studies (8445 patients with COPD). The patient population was stratified into age groups: young (≥40-<65 years; 52.3%), elderly (≥65-<75 years; 36.4%), and very elderly (≥75 years; 11.4%). The efficacy outcomes included improvements in trough forced expiratory volume in 1 s (FEV1), transition dyspnea index (TDI), and health status (St. George's Respiratory Questionnaire [SGRQ]); safety was also assessed at 12 weeks.

Results: At Week 12, the mean improvement in FEV1 with indacaterol 150 μg versus placebo was comparable in the elderly (150 mL), very elderly (160 mL), and young (170 mL) groups (p < 0.001 for all comparisons). Similar improvement in FEV1 was observed with indacaterol 300 μg versus placebo in each group (p < 0.001). This improvement was also significantly higher with indacaterol than formoterol, salmeterol, and tiotropium in all groups (p < 0.01). Both TDI and SGRQ scores significantly improved with indacaterol versus placebo across age groups (p < 0.001) and were significantly higher than that for tiotropium (p < 0.001). Incidences of adverse events among indacaterol- or placebo-treated patients were similar, regardless of the age group.

Conclusions: This pooled analysis suggests that the efficacy and safety of indacaterol treatment is similar between elderly and younger patients with COPD.

Keywords: COPD; Elderly; Indacaterol.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Adrenergic beta-2 Receptor Agonists / pharmacology
  • Aged
  • Aged, 80 and over
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / pharmacology
  • Bronchodilator Agents / therapeutic use
  • Clinical Trials, Phase III as Topic
  • Double-Blind Method
  • Dyspnea / drug therapy
  • Female
  • Forced Expiratory Volume / drug effects
  • Formoterol Fumarate / administration & dosage
  • Formoterol Fumarate / pharmacology
  • Health Status
  • Humans
  • Indans / administration & dosage
  • Indans / adverse effects
  • Indans / pharmacology*
  • Male
  • Middle Aged
  • Netherlands / epidemiology
  • Prevalence
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / epidemiology
  • Pulmonary Disease, Chronic Obstructive / physiopathology*
  • Quinolones / administration & dosage
  • Quinolones / adverse effects
  • Quinolones / pharmacology*
  • Randomized Controlled Trials as Topic / methods
  • Salmeterol Xinafoate / administration & dosage
  • Severity of Illness Index
  • Smoking / adverse effects
  • Tiotropium Bromide / administration & dosage
  • Tiotropium Bromide / pharmacology
  • Treatment Outcome
  • Vital Capacity / drug effects

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Bronchodilator Agents
  • Indans
  • Quinolones
  • Salmeterol Xinafoate
  • indacaterol
  • Formoterol Fumarate
  • Tiotropium Bromide