Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD.

Autor:	Muiser S; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands s.muiser@umcg.nl.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Imkamp K; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Seigers D; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Halbersma NJ; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Vonk JM; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Department of Epidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Luijk BHD; Department of Pulmonology, University Medical Centre Utrecht, Utrecht, The Netherlands., Braunstahl GJ; Department of Pulmonology, Franciscus Gasthuis, Rotterdam, The Netherlands., van den Berg JW; Department of Pulmonology, Isala Hospital, Zwolle, The Netherlands., Kroesen BJ; Laboratory of Medical Immunology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Kocks JWH; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; General Practitioners Research Institute, Groningen, The Netherlands.; Observational and Pragmatic Research Institute Pte Ltd, Singapore., Heijink IH; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Department of Pathology and Medical Biology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Reddel HK; Woolcock Institute of Medical Research, Glebe, New South Wales, Australia.; The University of Sydney, Sydney, New South Wales, Australia., Kerstjens HAM; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., van den Berge M; Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
Jazyk:	angličtina
Zdroj:	Thorax [Thorax] 2023 May; Vol. 78 (5), pp. 451-458. Date of Electronic Publication: 2023 Feb 01.
DOI:	10.1136/thorax-2022-219620
Abstrakt:	Background: Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Methods: Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. Results: In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). Conclusions: This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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