Why the study?
It was unknown whether the comparative efficacy of FF/UMEC/VI triple therapy versus FF/VI or UMEC/VI dual therapy varies according to prior exacerbation history and blood eosinophil counts.
Does fluticasone furoate/umeclidinium/vilanterol triple therapy reduce moderate/severe exacerbation rates compared to dual therapies in patients with symptomatic COPD and a history of exacerbations?
Does fluticasone furoate/umeclidinium/vilanterol triple therapy reduce moderate/severe exacerbation rates compared to dual therapies in patients with symptomatic COPD and a history of exacerbations?
Triple therapy with FF/UMEC/VI is more effective than dual therapies in reducing exacerbations and improving lung function in symptomatic COPD patients, regardless of prior exacerbation history.
Supports triple therapy over duals for exacerbation reduction in symptomatic COPD; extends RCT evidence consistently across all exacerbation histories.
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.
No takes yet. Share an insight, caveat, or question.
Halpin et al. (2020) studied this question.
Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context: