Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies

J. Mark FitzGerald (), Paul M. O’Byrne, Eric D. Bateman, Peter J. Barnes, Jinping Zheng, Stefan Ivanov, Rosa Lamarca, Ulrika Larsdotter, Ulrika Emerath, Gerreke Jansen, Margareta Puu, Vijay K. T. Alagappan, Filip Surmont and Helen K. Reddel
Additional contact information
J. Mark FitzGerald: University of British Columbia
Paul M. O’Byrne: McMaster University
Eric D. Bateman: University of Cape Town
Peter J. Barnes: Imperial College
Jinping Zheng: Guangzhou Medical University
Stefan Ivanov: AstraZeneca
Rosa Lamarca: AstraZeneca
Ulrika Larsdotter: AstraZeneca
Ulrika Emerath: AstraZeneca
Gerreke Jansen: AstraZeneca
Margareta Puu: AstraZeneca
Vijay K. T. Alagappan: AstraZeneca
Filip Surmont: AstraZeneca
Helen K. Reddel: University of Sydney

Drug Safety, 2021, vol. 44, issue 4, No 9, 467-478

Abstract: Abstract Introduction Budesonide-formoterol taken as needed is an emerging treatment for mild asthma. Objective We used data from the SYGMA studies to assess the safety of As-needed budesonide-formoterol compared with As-needed terbutaline and compared with maintenance budesonide. Methods SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12 years with physician-assessed mild asthma. Patients were randomized to As-needed budesonide-formoterol 200/6 μg, twice-daily budesonide 200 μg as maintenance plus As-needed terbutaline 0.5 mg, and As-needed terbutaline 0.5 mg (SYGMA 1 only). Adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs (DAEs), and study-defined asthma-related discontinuations from corresponding treatment groups in both studies were pooled. SYGMA 1 data were used for comparisons with As-needed terbutaline alone. Results The pooled analysis included 3366 patients in the As-needed budesonide-formoterol group and 3369 in the budesonide maintenance group, with AEs in 40.8% and 42.5% of patients, respectively. Common AEs included viral upper respiratory tract infection (viral URTI) and URTI. SAE, DAE, and asthma-related discontinuation rates were similar with As-needed budesonide-formoterol and maintenance budesonide. Potential local and systemic corticosteroid class effects were reported in ≤ 1% of patients for each budesonide-containing regimen. In SYGMA 1, AEs were more common in the As-needed terbutaline (n = 1277) than As-needed budesonide-formoterol (n = 1277) groups (42.7 vs. 38.0%), as were DAEs (2.9 vs. 0.8%) and asthma-related discontinuations (1.6 vs. 0.3%). Conclusions Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety profile similar to that of daily budesonide. No new safety signals were identified. ClinicalTrial.gov Identifiers NCT02149199 (SYGMA 1) and NCT02224157 (SYGMA 2).

Date: 2021
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DOI: 10.1007/s40264-020-01041-z

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