Eficacia y seguridad de terapia triple de furoato de fluticasona, vilanterol, umeclidinio (Trelegy ellipta®) frente a otras terapias en el tratamiento de la enfermedad obstructiva crónica: revisión sistemática y metanálisis

Abstract

Introduction: Trelegy ellipta® is a drug indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD). This medicine is composed of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) in a dose of 100 μg/62.5 μg/25 μg, respectively. The objective of this investigation was to demonstrate, by reviewing the scientific evidence, whether triple therapy is more effective and safer than different dual therapies in patients with COPD. Methodology: A systematic review was carried out following the PRISMA statement. The PubMed and Cochrane Library databases were consulted, considering all the articles available up to March 30, 2022 and taking into account the application of the inclusion and exclusion criteria. The variables chosen to measure the efficacy of the treatments were: the change in forced expiratory volume in the first second (FEV1) and values in the Saint George Respiratory Questionnaire (SGRQ). The safety of the treatments was evaluated by the number of adverse reactions grouped into cardiac disorders, infections, respiratory disorders, and nasopharyngitis. The retrieved papers were assessed for methodological quality and risk of bias in the studies. For the statistical analysis, the statistical package SIMFIT (v.7.2.7 University of Manchester) and the Review Manager (RevMan) systematic review program (v.5.4.1 Cochrane) were used. The heterogeneity of the studies to be compared was analyzed using the I2 and Q statistical tests. The fixed effects methodology was applied to the homogeneous studies and the random effects methodology to the heterogeneous studies. Results: Four studies were included in the analysis that found a significant improvement (p<0.05) in FEV1 (Forced expiratory volume in one second) in subjects treated with triple FF/UMEC/VI therapy compared to dual treatments. of Fluticasone Furoate/Vilanterol (FF/VI), Budesonide/Formoterol (BUD/FOR) and Budesonidad/Formoterol with Tiotropium (BUD/FOR + TIO). No difference was observed between triple therapy with a single inhaler and triple therapy with two inhalers. The changes in the value of the SGRQ showed a greater decrease in favor of the triple treatment compared to the other treatments. Regarding safety, triple treatment only presented significantly more adverse effects in cardiac disorders compared to treatment with FF/VI and in infections compared to treatment UMEC/VI. In the other cases, it was found that there are no significant differences in the triple treatment in terms of the aforementioned adverse reactions. Conclusion: The FF/UMEC/VI triple treatment presents greater efficacy and equal safety, with the exception of cardiac disorders and infections than the other dual treatments used in COPD. However, more clinical trials are required to assess the efficacy and safety of COPD treatment with triple therapy versus dual therapy