Resumen: 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. Idioma: Inglés DOI: 10.1177/1753466620963021 Año: 2020 Publicado en: Therapeutic Advances in Respiratory Disease 14 (2020), [10 pp] ISSN: 1753-4658 Factor impacto JCR: 4.031 (2020) Categ. JCR: RESPIRATORY SYSTEM rank: 22 / 64 = 0.344 (2020) - Q2 - T2 Factor impacto SCIMAGO: 1.022 - Pulmonary and Respiratory Medicine (Q2) - Pharmacology (medical) (Q2)