SESSION TYPE: COPD: Safety and Effectiveness of Newer Therapies
PRESENTED ON: Tuesday, October 23, 2012 at 02:45 PM - 04:15 PM
PURPOSE: To compare severe and moderate exacerbations over a one-year period of treatment with roflumilast vs. placebo in severe COPD patients and specific clinical subgroups from two multi-center trials.
METHODS: A post-hoc pooled analysis of two multi-center trials of roflumilast 500 mcg (M2-124 and M2-125) was performed. Occurrences of exacerbations, based on inpatient stays (defined as severe exacerbations) and systemic corticosteroid and/or antibiotic utilization (defined as moderate exacerbations), were identified for severe COPD patients and select subgroup populations with concomitant LABA, concomitant SAMA, ≥2 prior exacerbations, concomitant LABA and ≥2 prior exacerbations, and concomitant SAMA and ≥2 prior exacerbations. Group Sum Approach was used to calculate annualized estimates at a cohort level, and bootstrapping was performed to generate standard errors. Wilcoxon rank-sum tests were performed for significance testing.
RESULTS: Of an initial 4,515 screened trial participants, 1,406 roflumilast patients and 1,429 placebo patients met the study’s inclusion criteria. The overall median age was 64 years, and 77% of patients were male. Among severe COPD patients, the roflumilast treatment group had a significantly lower number of severe exacerbations per patient per year compared with the placebo group (0.17 vs. 0.21, p=0.0442). This pattern was repeated in two of the five subgroups: in patients with ≥2 prior exacerbations (0.25 vs. 0.36, p=0.0331) and in patients with concomitant LABA and ≥2 prior exacerbations (0.30 vs. 0.46, p=0.0395). The mean number of moderate exacerbations per patient per year was significantly lower in the roflumilast group compared with the placebo group in the overall severe COPD patient group (1.08 vs. 1.32, p<0.0001) and in patients with concomitant LABA (1.13 vs. 1.45, p=0.0005), concomitant SAMA (1.38 vs. 1.64, p=0.0169), ≥2 prior exacerbations (1.39 vs. 1.79, p=0.0028), and concomitant LABA and ≥2 prior exacerbations (1.34 vs. 1.79, p=0.0109).
CONCLUSIONS: Treatment with roflumilast reduced severe and moderate exacerbations in the overall severe COPD patient group and in specific clinical subgroups when compared with placebo.
CLINICAL IMPLICATIONS: Roflumilast offers targeted COPD treatment option.
DISCLOSURE: Jason Yeaw: Consultant fee, speaker bureau, advisory committee, etc.: Consultant
Cheryl Ferrufino: Consultant fee, speaker bureau, advisory committee, etc.: Consultant
Shawn Sun: Employee: Employee of Forest Research Institute
Michelle Mocarski: Employee: Employee of Forest Research Institute
Donald Yin: Employee: Employee of Forest Research Institute
Julie Munakata: Consultant fee, speaker bureau, advisory committee, etc.: Consultant
No Product/Research Disclosure InformationIMS Consulting Group, Alexandria, VA