Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for Chronic Obstructive Pulmonary Disorder (COPD)

Lauren Lipscomb, Mercer University College of Pharmacy

 

The National Institute for Health and Care Excellence (NICE) recommends that patients with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators, the following should be offered as maintenance therapy; if forced expiratory volume in one second (FEV1) ≥ 50% predicted: either long-acting beta-2 agonist (LABA) or long-acting muscarinic antagonist (LAMA); if FEV1 < 50% predicted: either LABA with an inhaled corticosteroid (ICS) in a combination inhaler, or a LAMA. [1]

 

The Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend a long-acting anticholinergic, or combination of a long acting beta-2 agonist plus and inhaled corticosteroid for patients classified as group C (patients with more than two exacerbations per year, a modified medical research council score (mMRC) <1, or a COPD assessment test score (CAT) <10) and group D (patients with more than two exacerbations per year, an mMRC >2, or a CAT >10 ). [2]

 

Title: Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD [3]
Design Randomized, double-blind, double-dummy, noninferiority trial; N= 3,362
Objective Show whether indacaterol–glycopyrronium would be noninferior to salmeterol–fluticasone in reducing the rate of COPD exacerbations
Study Groups Indacaterol–glycopyrronium (n= 1,680); salmeterol–fluticasone (n=1,682)
Methods Patients who had COPD with a history of at least one exacerbation during the previous year were randomly assigned to receive, by inhalation, either the LABA, indacaterol (110 μg) plus the LAMA, glycopyrronium (50 μg) once daily or the LABA, salmeterol (50 μg) plus the inhaled glucocorticoid, fluticasone (500 μg) twice daily.
Duration July 2013 to September 2015
Primary Outcome Measure Annual rate of all COPD exacerbations

 

Baseline Characteristics Characteristic Indacaterol–glycopyrronium (n= 1,680) Salmeterol–fluticasone (n=1,682)
Mean age; y 64.6 64.5
Male sex; n (%) 1,299 (77.3) 1,258 (74.8)
Duration of COPD; y 7.2 7.3
Use of inhaled corticosteroids at screening; n (%) 954 (56.8) 669 (39.8)
Results Outcome Indacaterol–glycopyrronium (n= 1,680) Salmeterol–fluticasone (n=1,682)
Rate of COPD exacerbations in one year 3.59 4.03
Adverse Events Common Adverse Events: worsening of COPD: indacaterol–glycopyrronium (77.4%), salmeterol–fluticasone (81.8%); nasopharyngitis: indacaterol–glycopyrronium (11.7%), salmeterol–fluticasone (11.6%); viral upper respiratory tract infection: indacaterol–glycopyrronium (7.9%), salmeterol–fluticasone (8.2%); bacterial upper respiratory tract infection: indacaterol–glycopyrronium (7.4%), salmeterol–fluticasone (10%)
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: Indacaterol–glycopyrronium (15.5%); salmeterol–fluticasone (17.9%)
Study Author Conclusions Indacaterol–glycopyrronium was more effective than salmeterol–fluticasone in preventing COPD exacerbations in patients with a history of exacerbation during the previous year.

 

This study found that combination therapy of a LABA plus a LAMA (indacaterol–glycopyrronium) was more effective than a LABA plus an inhaled corticosteroid (salmeterol–fluticasone) in preventing COPD exacerbations. One adverse effect that needs to be taken into consideration is the worsening of COPD despite the prevention of exacerbations in both drug groups. Current guidelines do not recommend using a combination LAMA/LABA for COPD exacerbations. However, if the same results are seen in future studies of this nature, addition of LAMA/LABA combination therapy needs to be considered as a possible prophylactic strategy for COPD exacerbations. This study used a per-protocol analysis of their study population, which gives a better representation of how the drugs performed against each other than if an intent-to-treat analysis had been used.

 

References

  1. The National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. https://www.nice.org.uk/guidance/cg101/resources/chronic-obstructive-pulmonary-disease-in-over-16s-diagnosis-and-management-35109323931589
  2. Vestbo J, Hurd SS, Agustí AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013;187(4):347-65.
  3. Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016;

 

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