Salmeterol/fluticasone combination instead of indacaterol or vice-versa?
- 1Respiratory Disease Unit, University of Modena and Reggio Emilia, Modena, Italy
- 2Hospital Clinic de Barcelona, CIBER en Enfermedades Respiratorias (CIBERES), Barcelona, Spain
- 3Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain
- Leonardo M. Fabbri, University of Modena and Reggio Emilia,Respiratory Disease Unit, Pozzo 71, Modena, Italy. Email: leonardo.fabbri{at}unimore.it
Abstract
Lung function and relevance on choice of indacaterol or salmeterol/fluticasone combination in moderate COPD patients http://ow.ly/HGOCV
To the Editor:
The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study, published in the December edition of the European Respiratory Journal, concluded that that “patients with moderate COPD and no exacerbations in the previous year can be switched from salmeterol/fluticasone (SFC) to indacaterol with no efficacy loss” [1]. We would like to respectfully challenge this conclusion (as suggested also by the acronym “INSTEAD”) since, in our opinion, the data presented do not support it. First, the study was designed and powered to address a short-term (12 weeks), physiological question (the primary outcome was non-inferiority of lung function changes (through forced expiratory volume in 1 s (FEV1)). This study design does not allow any inference about the relative clinical positioning of these two therapeutic alternatives at longer term (daily control or future risk, e.g. exacerbation, progression of disease, or mortality). Secondly, authors included in the study “patients receiving SFC 50/500 mg for ≥3 months, with no chronic obstructive pulmonary disease (COPD) exacerbations for >1 year before the study (patients for whom inhaled corticosteroid (ICS) is not recommended)”. In our opinion, their interpretation that ICS are not recommended in these patients is both arguable and relevant. Arguable, because authors cannot disregard the possibility that patients did not have exacerbations in the previous year precisely because they were treated with ICS. Relevant because if these patients did not really need ICS, then it should not surprise that ICS withdrawal was “non-inferior” to bronchodilator treatment. Finally, based on the INSTEAD results, the exact opposite conclusions might be reached. This is, given that: 1) treatment with indacaterol is not inferior to treatment with SFC in terms of lung function (primary outcome), and/or daily control (symptoms, quality of life); and, 2) there is no information on the long-term effects of indacaterol on the rate of exacerbations, whereas this is well established for the SFC combination in a properly designed and longer-term study [2–4], the latter might be favoured over indacaterol. It goes without saying that both conclusions (this one and that of the INSTEAD study) are speculative, and thus properly designed and powered studies are required before any evidence based recommendation on the use of ICS in COPD can be reliably made [5–7]. In any case, we congratulate the authors of the INSTEAD study for their interesting work that contribute to another piece of evidence on the debate of when to use ICS in COPD. However, we honestly believe that the clinical over-interpretation of their results may not be in the best interest of patients, since there is a group of patients with COPD who can clearly benefit from ICS in combination with long-acting bronchodilators, including those with repeated exacerbations (despite adequate bronchodilator treatment) and the asthma-COPD overlap syndrome [8].
Footnotes
Conflict of interest: Disclosures can be found alongside the online version of this article at erj.ersjournals.com
- Received December 10, 2014.
- Accepted December 11, 2014.
- Copyright ©ERS 2015