PT  - JOURNAL ARTICLE
AU  - Fitzgerald, Mark
AU  - O’Byrne, Paul M.
AU  - Bateman, Eric D.
AU  - Barnes, Peter J.
AU  - Zhong, Nanshan
AU  - Alagappan, Vijay
AU  - Whelan, Glenn
AU  - Lamarca, Rosa
AU  - Puu, Margareta
AU  - Reddel, Helen K.
TI  - Number needed to treat (NNT) to have an additional patient free from a severe or moderate/severe exacerbation: post-hoc analysis of SYGMA 1 in mild asthma
AID  - 10.1183/13993003.congress-2019.PA3716
DP  - 2019 Sep 28
TA  - European Respiratory Journal
PG  - PA3716
VI  - 54
IP  - suppl 63
4099  - http://erj.ersjournals.com/content/54/suppl_63/PA3716.short
4100  - http://erj.ersjournals.com/content/54/suppl_63/PA3716.full
SO  - Eur Respir J2019 Sep 28; 54
AB  - Introduction: Exacerbations can occur even in mild asthma. The risk of exacerbations can be reduced with as-needed budesonide/formoterol (BUD/FORM) or BUD maintenance+as-needed terbutaline vs as-needed terbutaline alone (SYGMA 1; NCT02149199).Aims and Objectives: This post-hoc analysis of SYGMA 1 examined the NNT with as-needed BUD/FORM or BUD maintenance to have an additional patient (pt) free from a severe or moderate/severe exacerbation over 1 year.Methods: SYGMA 1 was a 52-week, double-blind trial of pts with mild asthma randomised to placebo bid+terbutaline 0.5mg as needed (n=1277), placebo bid+as-needed BUD/FORM 200/6µg (n=1277) or BUD 200µg bid+as-needed terbutaline (n=1282). The NNT for as-needed BUD/FORM and BUD maintenance vs as-needed terbutaline after 1 year of treatment were compared.Results: When compared with as-needed terbutaline, treating 16 pts with as-needed BUD/FORM, or 17 pts with maintenance BUD, for 1 year, prevented 1 additional pt having a severe exacerbation, reducing to 9 and 10 pts, respectively, for moderate/severe exacerbations (Table).Conclusions: The numbers needed to treat for a year with as-needed BUD/FORM to prevent one pt having a severe or moderate/severe exacerbation vs as-needed terbutaline were comparable to BUD maintenance, regardless of pre-study treatment, supporting a role for these therapies in mild asthma.FootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA3716.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).