The results of a network meta-analysis (Nma) that compared the triple and the double therapy at Gsk with other therapeutic options show that the combination of fluticasone furoate, umeclidinium and vilanterol (Ics + Laba + Lama) and that of umeclidinium and vilanterol (Laba + Lama) are distinguished by efficacy, in terms of improvement of lung function and reduction of exacerbationscompared to the other treatments available for i patients with obstructive corneal pulmonary disease (BPCO). This was announced by the GSK company in a note.
This statistical analysis of aggregated data produced by several comparative studies, used to compare, in the absence of direct studies, the efficacy and safety of three or more treatments intended for the same clinical indication, allowing to define a ranking of efficacy and safety, it was presented a few weeks ago at the congress of the European Society of Pulmonology in Barcelona and, earlier in May, at the American thoracic society in San Francisco. Results of this type had already been seen from the direct comparison of the dual therapy (umeclidinium and vilanterol) both towards tiotropium and olodaterol and glycopyrronium and formoterol and the triple (fluticasone furoate, umeclidinium and vilanterol) compared to the other triple therapies Ics / Lama + Laba and to the dual Ics / Laba and Laba / Lama therapies, which represent the gold standard, i.e. the reference therapy, of scientific evidence.
In particular – reads the note – the meta-analysis shows that the triple association of Gsk shows favorable clinical outcomes in terms of improvement of lung function and reduction of exacerbations. Regarding umeclidinium and vilanterol, the results reinforce the evidence of long-term efficacy, with a significant improvement in trough FEV1, a key parameter for assessing lung function through spirometry, compared to both monotherapy bronchodilators and dual combinations. Lama / Laba.
To reach the conclusions of the NMA, about 10 thousand studies were analyzed over the course of 3 and a half years (from 17 March 2017 to 16 October 2020) and 23 were identified that met the inclusion criteria: 15 studies that reported the data trough FEV1 at 12 weeks, 5 studies at 24 weeks and 17 studies reporting data on the rate of exacerbations. The improvement in lung function at 12 and 24 weeks was significantly greater for triple (fluticasone furoate, umeclidinium and vilanterol) compared to both dual and triple single-dispenser comparator therapies (specifically, both budenoside, glycopyrronium, and formoterol) ).
On the exacerbation front, 17 studies were included in the meta analysis. The combination fluticasone furoate, umeclidinium and vilanterol was found to be significantly more effective in reducing the annual rate of exacerbations than dual therapies and both dosages of budenoside, glycopyrronium and formoterol and is numerically superior to beclomethasone dipropionate, formoterol and glycopyrronium with a difference of 27%. The systemic literature review for dual therapy examined 8,171 studies, selecting 49 based on the required inclusion criteria. At the moment, data relating to trough FEV1 are available. The combination of umeclidinium and vilanterol in this case demonstrated a decisive improvement in respiratory function compared to the other therapies examined (single bronchodilators or dual combinations, both at 12 and 24 weeks). In particular, an important advantage was observed on glycopyrronium / formoterol of 87 mL and 42-55 mL compared to both tiotropium / olodaterol dosages.
Certainly head-to-head trials represent the gold standard of evidence in clinical research, however some comparisons may require a very large sample size or a long duration of treatments, factors that increase the complexity and costs of the study. Therefore, in the absence of direct comparisons, the possibility of an indirect comparison offered by a network meta-analysis can provide an answer to clinical questions.