Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT

José M Marín, Luis Mateos, Juan Roldán, José M Echave-Sustaeta, Sergi Pascual-Guardia, Maria V Pardo, Beatriz Velasco, C Elaine Jones, Sally Kilbride, David A Lipson, José M Marín, Luis Mateos, Juan Roldán, José M Echave-Sustaeta, Sergi Pascual-Guardia, Maria V Pardo, Beatriz Velasco, C Elaine Jones, Sally Kilbride, David A Lipson

Abstract

Objectives: The IMPACT trial has compared the benefit in the reduction of moderate/severe exacerbations of single inhaler triple therapy (SITT) with fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus dual therapy with FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA) in the treatment of patients with chronic obstructive disease (COPD). This study performs a subgroup analysis of the cohort from Spain in the IMPACT study.

Materials and methods: In IMPACT, a 52-week randomized, double-blind, parallel-group, multicenter study (N = 10,355), patients ⩾40 years of age with COPD and ⩾1 moderate/severe exacerbations in the previous year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg administered via the Ellipta inhaler. Here, we present a subgroup analysis of the 499 patients from Spain, included in the intent-to-treat (ITT) population in the study. Endpoint assessed included exposure-adjusted rate of moderate and severe exacerbations.

Results: In the Spain cohort, the exposure-adjusted rate of on-treatment moderate/severe COPD exacerbations per year for FF/UMEC/VI was 1.31 versus 1.43 and 1.57 for FF/VI and UMEC/VI, respectively. No new adverse events were identified. The results are consistent with those observed in the overall ITT study population.

Conclusion: In the Spain cohort of the IMPACT study, patients receiving triple therapy with FF/UMEC/VI had a lower exposure-adjusted rate of exacerbations compared with FF/VI and UMEC/VI, similar to the overall population.Study Title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary DiseaseURL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=CTT116855/ https://ichgcp.net/clinical-trials-registry/NCT02164513Registration number: GSK (CTT116855/NCT02164513).The reviews of this paper are available via the supplemental material section.

Keywords: Chronic obstructive pulmonary disease (COPD); LABA; LAMA; glucocorticoid; randomized clinical trial; triple therapy.

Conflict of interest statement

Declaration of Conflicting Interests: José M. Marín reports personal fees from GlaxoSmithKline (GSK), Chiesi and Astra-Zeneca, non-financial support from Menarini.

Luis Mateos reports personal fees from GSK, Novartis, Astra Zeneca, Boehringer-Ingelheim, Chiesi, Teva, Rovi and Ferrer.

Juan Roldán declared no conflicts of interest.

Sergio Pascual reports personal fees from GSK, Boehringer-Ingelheim and TEVA.

José M. Echave-Sustaeta received fees as a speaker and advisor for GSK and as a researcher in clinical studies sponsored by GSK, Novartis, Astra Zeneca, Boehringer Ingelheim, Sanofi and Bayer.

María V. Pardo, Beatriz Velasco, C. Elaine Jones, Sally Kilbride and David A. Lipson are GSK employees and hold stock/shares in GSK.

Figures

Figure 1.
Figure 1.
Comparison of the annual exposure-adjusted rate of moderate/severe exacerbations per patient at 52 weeks for each treatment arm for Spain cohort versus the global cohort included in the IMPACT study. FF, fluticasone furoate; ITT, intent-to-treat; UMEC, umeclidinium; VI, vilanterol.

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