The effect of exacerbation history on outcomes in the IMPACT trial
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The effect of exacerbation history on outcomes in the IMPACT trial. / Halpin, David M.G.; Dransfield, Mark T.; Han, Mei Lan K.; Elaine Jones, C.; Kilbride, Sally; Lange, Peter; Lipson, David A.; Lomas, David A.; Martinez, Fernando J.; Pascoe, Steve; Singh, Dave; Wise, Robert; Criner, Gerard J.
I: European Respiratory Journal, Bind 55, Nr. 5, 1901921, 2020.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - The effect of exacerbation history on outcomes in the IMPACT trial
AU - Halpin, David M.G.
AU - Dransfield, Mark T.
AU - Han, Mei Lan K.
AU - Elaine Jones, C.
AU - Kilbride, Sally
AU - Lange, Peter
AU - Lipson, David A.
AU - Lomas, David A.
AU - Martinez, Fernando J.
AU - Pascoe, Steve
AU - Singh, Dave
AU - Wise, Robert
AU - Criner, Gerard J.
N1 - Publisher Copyright: Copyright © ERS 2020.
PY - 2020
Y1 - 2020
N2 - IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations. Subgroup analyses assessed whether the efficacy of FF/UMEC/VI versus FF/VI or UMEC/VI and UMEC/VI versus FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≽2 moderate/no severe; n=4628 (45%)) and severe (≽1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/ severe exacerbation rate (pre-specified), lung function and health status (both post-hoc). Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group versus FF/VI (single moderate 20% (10–29), frequent moderate 11% (2–19), severe 17% (7–26)) and versus UMEC/VI (single moderate 18% (5–29), frequent moderate 29% (21–37), severe 26% (14–35)). Moderate/ severe exacerbation rates were reduced in the FF/VI group versus UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (−12–18), frequent moderate 21% (11–29), severe 11% (−3–22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status versus both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function versus FF/VI in all subgroups. Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.
AB - IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations. Subgroup analyses assessed whether the efficacy of FF/UMEC/VI versus FF/VI or UMEC/VI and UMEC/VI versus FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≽2 moderate/no severe; n=4628 (45%)) and severe (≽1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/ severe exacerbation rate (pre-specified), lung function and health status (both post-hoc). Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group versus FF/VI (single moderate 20% (10–29), frequent moderate 11% (2–19), severe 17% (7–26)) and versus UMEC/VI (single moderate 18% (5–29), frequent moderate 29% (21–37), severe 26% (14–35)). Moderate/ severe exacerbation rates were reduced in the FF/VI group versus UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (−12–18), frequent moderate 21% (11–29), severe 11% (−3–22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status versus both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function versus FF/VI in all subgroups. Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.
U2 - 10.1183/13993003.01921-2019
DO - 10.1183/13993003.01921-2019
M3 - Journal article
C2 - 32299860
AN - SCOPUS:85085265514
VL - 55
JO - The European respiratory journal
JF - The European respiratory journal
SN - 0903-1936
IS - 5
M1 - 1901921
ER -
ID: 286926910