Abstract
Background/Rationale: Roflumilast (ROF), an oral, selective phosphodiesterase 4 inhibitor, reduces the rate of moderate and severe exacerbations. Oral steroids are frequently used to treat exacerbations, but whether ROF affects oral steroid exposure is not known. Using data pooled from two 1-year studies (NCT00297102 and NCT00297115), we investigated the effect of ROF on the need for oral steroids.
Methods: Patients with COPD and a history of exacerbations and chronic bronchitis were randomised to receive ROF 500μg once daily (n=1537) or placebo (PBO; n=1554) for 52 weeks. Rate of moderate or severe (leading to hospitalisation or death) exacerbations was a co-primary endpoint. Steroid use (dose/day and days of use) for the treatment of exacerbations was recorded.
Results: The mean rate of moderate or severe exacerbations in ROF- and PBO-treated patients (per patient/year) was 1.14 vs 1.37, respectively (reduction 16.9%, p=0.0003). The mean number of days on which patients had exacerbations was reduced with ROF vs PBO (moderate 23.7 vs 27.3; severe 21.5 vs 25.0). The mean duration (days) of exacerbations was also reduced with ROF vs PBO (moderate 13.4 vs 13.9; severe 17.4 vs 19.5). Patients receiving ROF had a lower mean daily steroid dose (3.9mg/day) than those receiving PBO (4.2mg/day).
Conclusions: In patients with COPD associated with chronic bronchitis, ROF significantly reduced the rate of moderate or severe exacerbations. ROF treatment also reduced the duration of exacerbations, particularly for severe exacerbations requiring hospitalisation. The overall steroid load and duration of steroid treatment needed to manage exacerbations was lower with ROF.
- © 2011 ERS