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DOI: 10.1055/s-0041-1723286
COPD exacerbation benefits relative to pneumonia risk with budesonide/glycopyrronium/formoterol metered dose inhaler: analyses from ETHOS
Background: In the Phase III, 52-week ETHOS study (NCT02465567), budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) fixed-dose combination significantly reduced exacerbations vs. dual therapies. However, use of inhaled corticosteroids (ICS) may also increase pneumonia risk.
Objective: To quantify exacerbation benefits relative to pneumonia risk (expressed as numbers needed to treat [NNT] and numbers needed to harm [NNH], respectively) in ETHOS.
Methods: Patients with moderate-to-very severe COPD and ≥ 1 moderate/severe exacerbation in the prior year received BGF MDI 320/14.4/10 µg or 160/14.4/10 µg, glycopyrronium/formoterol (GFF) MDI 14.4/10 µg or budesonide/formoterol (BFF) MDI 320/10 µg twice-daily via a single Aerosphere inhaler. Exacerbation and pneumonia rates were used to calculate NNT and NNH.
Results: BGF MDI 320 µg reduced exacerbation rates vs. GFF MDI (NNT = 3 [95% CI 3, 5]) and vs. BFF MDI (NNT = 7 [95% CI 4, 18]), (mITT, n = 8509). Pneumonia rates across treatments were 0.02 – 0.05 per patient year, and were lower for BGF MDI than BFF MDI; for BGF MDI 320 µg vs. GFF MDI, NNH = 58 (95% CI 29, 152) ([Table 1]).
Conclusions: In patients with moderate/very severe COPD, BGF MDI 320 µg reduced exacerbation risk vs. both dual therapies. For the ICS component, the NNH (BGF MDI 320 µg vs. GFF MDI) suggests a low pneumonia risk for BGF MDI relative to its benefits on exacerbations.
BGF MDI |
BGF MDI |
GFF MDI |
BFF MDI |
|
---|---|---|---|---|
Model-adjusted rates of moderate/severe exacerbations per year |
1.08 |
1.07 |
1.42 |
1.24 |
Model-adjusted rates of confirmed pneumonia per year |
0.04 |
0.03 |
0.02 |
0.05 |
NNT moderate/severe exacerbations (95% CI) |
||||
BGF 320/14.4/10 µg vs. comparator |
– |
– |
3 (3, 5) |
7 (4, 18) |
NHH confirmed pneumonia (95% CI) |
||||
BGF MDI 320/14.4/10 µg vs. comparator |
– |
– |
58 (29, 152) |
N/Aa |
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Publikationsverlauf
Artikel online veröffentlicht:
30. April 2021
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