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DOI: 10.1055/s-0035-1544632
The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study
Background: Although guidance recommends ICS for prevention of recurrent COPD exacerbations, there is still uncertainty about the benefits of ICS.
Objective: To evaluate the effects of stepwise withdrawal of ICS in patients (pts) with GOLD 3 – 4 COPD and a history of exacerbation who are treated with LAMA+LABA.
Methods: WISDOM (NCT00975195) was a 12-month, double-blind, parallel-group, active-controlled study in which all pts received triple therapy (tiotropium 18 µg QD, salmeterol 50 µg BID and fluticasone 500 µg BID) for a 6-week run-in period. Pts were randomised 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks (dose reduction every 6 weeks). Primary end point (time to first moderate or severe on-treatment exacerbation) is reported here.
Results: 2485 pts were treated (2049 male); mean age was 63.8 years and mean baseline FEV1 was 0.975 L (34.2% predicted).
Time to events (days) |
||||||||||
No. at risk |
||||||||||
ICS |
1243 |
1059 |
927 |
827 |
763 |
694 |
646 |
615 |
581 |
14 |
ICS withdrawal |
1242 |
1090 |
965 |
825 |
740 |
688 |
646 |
607 |
570 |
19 |
ICS withdrawal was non-inferior to continued ICS for time to first moderate or severe on-treatment COPD exacerbation (hazard ratio 1.058; upper limit of the 95% CI below the pre-specified non-inferiority margin of 1.2 [0.941, 1.189]). No significant safety signals were identified.
Conclusions: In pts with GOLD 3 – 4 COPD receiving dual bronchodilation, exacerbation risk is non-inferior with ICS withdrawal compared to ICS therapy.
Funding: Boehringer Ingelheim.
Presented at ERS congress 2014