PT  - JOURNAL ARTICLE
AU  - Jadwiga Wedzicha
AU  - Klaus Rabe
AU  - Peter Calverley
AU  - Fernando Martinez
AU  - Dirk Bredenbröker
AU  - Manja Brose
AU  - Udo-Michael Goehring
TI  - Efficacy of roflumilast in the frequent exacerbation COPD phenotype
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p3355
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p3355.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p3355.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Background: COPD exacerbations (EXs) are associated with increased morbidity, mortality and disease progression. The ECLIPSE study showed the best predictor of future EXs is a history of EXs, identifying a frequent exacerbator phenotype maintained over time. Roflumilast (ROF) reduces EX rate in frequent exacerbators, but its relative effect in this phenotype is not known.Methods: In a post-hoc pooled analysis of two 1-yr studies of ROF 500μg in pts with severe COPD, chronic bronchitis and a history of EXs, pts were classified as frequent (≥2 events) or infrequent (1 event) exacerbators based on moderate/severe EX history in the previous yr. EX frequency status was analysed in ROF- and placebo (PBO)-treated pts at baseline and at yr 1.Results: Among ROF-treated frequent exacerbators (n=413), 32.0% still had frequent EXs at yr 1 vs 40.8% of PBO-treated pts (n=417; RR=0.799, p=0.0148). Among infrequent exacerbators, 17.5% of ROF-treated pts (n=1124) had ≥2 EXs at yr 1 vs 22.9% of PBO-treated pts (n=1137; RR=0.768, p=0.0018). This reduction was similar when considering concomitant LABA, previous ICS treatment or severe EXs leading to hospitalisation/death. When analysed by COPD severity, 26.4% of ROF-treated frequent exacerbators with severe COPD (FEV1 30–50% predicted, n=246) still had frequent EXs at yr 1 vs 38.9% of PBO-treated pts (n=239; RR=0.683, p=0.0042); the percentage of frequent exacerbators was similar between treatments in pts with very severe COPD (FEV1 <30%).Conclusions: This analysis shows that ROF shifts pts from the frequent to the more stable infrequent exacerbator state. This effect was not seen in frequent exacerbators with very severe COPD, highlighting the need for early treatment initiation.