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

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...

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Veröffentlicht in:Drug safety 2021-04, Vol.44 (4), p.467-478
Hauptverfasser: FitzGerald, J. Mark, O’Byrne, Paul M., Bateman, Eric D., Barnes, Peter J., Zheng, Jinping, Ivanov, Stefan, Lamarca, Rosa, Larsdotter, Ulrika, Emerath, Ulrika, Jansen, Gerreke, Puu, Margareta, Alagappan, Vijay K. T., Surmont, Filip, Reddel, Helen K.
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container_end_page 478
container_issue 4
container_start_page 467
container_title Drug safety
container_volume 44
creator FitzGerald, J. Mark
O’Byrne, Paul M.
Bateman, Eric D.
Barnes, Peter J.
Zheng, Jinping
Ivanov, Stefan
Lamarca, Rosa
Larsdotter, Ulrika
Emerath, Ulrika
Jansen, Gerreke
Puu, Margareta
Alagappan, Vijay K. T.
Surmont, Filip
Reddel, Helen K.
description 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).
doi_str_mv 10.1007/s40264-020-01041-z
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Mark ; O’Byrne, Paul M. ; Bateman, Eric D. ; Barnes, Peter J. ; Zheng, Jinping ; Ivanov, Stefan ; Lamarca, Rosa ; Larsdotter, Ulrika ; Emerath, Ulrika ; Jansen, Gerreke ; Puu, Margareta ; Alagappan, Vijay K. T. ; Surmont, Filip ; Reddel, Helen K.</creator><creatorcontrib>FitzGerald, J. Mark ; O’Byrne, Paul M. ; Bateman, Eric D. ; Barnes, Peter J. ; Zheng, Jinping ; Ivanov, Stefan ; Lamarca, Rosa ; Larsdotter, Ulrika ; Emerath, Ulrika ; Jansen, Gerreke ; Puu, Margareta ; Alagappan, Vijay K. T. ; Surmont, Filip ; Reddel, Helen K.</creatorcontrib><description>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).</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-020-01041-z</identifier><identifier>PMID: 33548020</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Administration, Inhalation ; Adverse events ; Asthma ; Asthma - drug therapy ; Bronchodilator Agents ; Budesonide ; Budesonide - adverse effects ; Corticosteroids ; Drug Combinations ; Drug dosages ; Drug Safety and Pharmacovigilance ; Ethanolamines - therapeutic use ; Formoterol ; Formoterol Fumarate - adverse effects ; Humans ; Inflammation ; Inhalers ; Maintenance ; Medicine ; Medicine &amp; Public Health ; NCT ; NCT02149199 ; NCT02224157 ; Original ; Original Research Article ; Patients ; Pharmacology/Toxicology ; Respiratory tract ; Respiratory tract diseases ; Safety ; Statistical analysis ; Teenagers ; Terbutaline ; Terbutaline - adverse effects</subject><ispartof>Drug safety, 2021-04, Vol.44 (4), p.467-478</ispartof><rights>The Author(s) 2021</rights><rights>Copyright Springer Nature B.V. 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Mark</creatorcontrib><creatorcontrib>O’Byrne, Paul M.</creatorcontrib><creatorcontrib>Bateman, Eric D.</creatorcontrib><creatorcontrib>Barnes, Peter J.</creatorcontrib><creatorcontrib>Zheng, Jinping</creatorcontrib><creatorcontrib>Ivanov, Stefan</creatorcontrib><creatorcontrib>Lamarca, Rosa</creatorcontrib><creatorcontrib>Larsdotter, Ulrika</creatorcontrib><creatorcontrib>Emerath, Ulrika</creatorcontrib><creatorcontrib>Jansen, Gerreke</creatorcontrib><creatorcontrib>Puu, Margareta</creatorcontrib><creatorcontrib>Alagappan, Vijay K. T.</creatorcontrib><creatorcontrib>Surmont, Filip</creatorcontrib><creatorcontrib>Reddel, Helen K.</creatorcontrib><title>Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>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. 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Mark ; O’Byrne, Paul M. ; Bateman, Eric D. ; Barnes, Peter J. ; Zheng, Jinping ; Ivanov, Stefan ; Lamarca, Rosa ; Larsdotter, Ulrika ; Emerath, Ulrika ; Jansen, Gerreke ; Puu, Margareta ; Alagappan, Vijay K. 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Mark</au><au>O’Byrne, Paul M.</au><au>Bateman, Eric D.</au><au>Barnes, Peter J.</au><au>Zheng, Jinping</au><au>Ivanov, Stefan</au><au>Lamarca, Rosa</au><au>Larsdotter, Ulrika</au><au>Emerath, Ulrika</au><au>Jansen, Gerreke</au><au>Puu, Margareta</au><au>Alagappan, Vijay K. T.</au><au>Surmont, Filip</au><au>Reddel, Helen K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2021-04-01</date><risdate>2021</risdate><volume>44</volume><issue>4</issue><spage>467</spage><epage>478</epage><pages>467-478</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><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).</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>33548020</pmid><doi>10.1007/s40264-020-01041-z</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects Administration, Inhalation
Adverse events
Asthma
Asthma - drug therapy
Bronchodilator Agents
Budesonide
Budesonide - adverse effects
Corticosteroids
Drug Combinations
Drug dosages
Drug Safety and Pharmacovigilance
Ethanolamines - therapeutic use
Formoterol
Formoterol Fumarate - adverse effects
Humans
Inflammation
Inhalers
Maintenance
Medicine
Medicine & Public Health
NCT
NCT02149199
NCT02224157
Original
Original Research Article
Patients
Pharmacology/Toxicology
Respiratory tract
Respiratory tract diseases
Safety
Statistical analysis
Teenagers
Terbutaline
Terbutaline - adverse effects
title Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies
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