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

Autor: Susan Muiser, Kai Imkamp, Dianne Seigers, Nynke J Halbersma, Judith M Vonk, Bart H D Luijk, Gert-Jan Braunstahl, Jan-Willem van den Berg, Bart-Jan Kroesen, Janwillem W H Kocks, Irene H Heijink, Helen K Reddel, Huib A M Kerstjens, Maarten van den Berge
Přispěvatelé: Groningen Research Institute for Asthma and COPD (GRIAC), Translational Immunology Groningen (TRIGR)
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Thorax, 451-458. BMJ PUBLISHING GROUP
STARTPAGE=451;ENDPAGE=458;ISSN=0040-6376;TITLE=Thorax
ISSN: 1468-3296
0040-6376
DOI: 10.1136/thorax-2022-219620
Popis: BackgroundMaintenance 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).MethodsPatients 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.ResultsIn 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, pConclusionsThis 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.
Databáze: OpenAIRE