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Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD Rennard SI; Calverley PM; Goehring UM; Bredenbroker D; Martinez FJRespir Res 2011[Jan]; 12 (1): 18BACKGROUND: As chronic obstructive pulmonary disease (COPD) is a heterogeneous disease it is unlikely that all patients will benefit equally from a given therapy. Roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor, has been shown to improve lung function in moderate and severe COPD but its effect on exacerbations in unselected populations was inconclusive. This led to the question of whether a responsive subset existed that could be investigated further. METHODS: The datasets of two previous replicate, randomized, double-blind, placebo-controlled, parallel-group studies (oral roflumilast 500 mug or placebo once daily for 52 weeks) that were inconclusive regarding exacerbations were combined in a post-hoc, pooled analysis to determine whether roflumilast reduced exacerbations in a more precisely defined patient subset. RESULTS: The pooled analysis included 2686 randomized patients. Roflumilast significantly decreased exacerbations by 14.3% compared with placebo (p = 0.026). Features associated with this reduction were: presence of chronic bronchitis with or without emphysema (26.2% decrease, p = 0.001), presence of cough (20.9% decrease, p = 0.006), presence of sputum (17.8% decrease, p = 0.03), and concurrent use of inhaled corticosteroids (ICS; 18.8% decrease, p = 0.014). The incidence of adverse events was similar with roflumilast and placebo (81.5% vs 80.1%), but more patients in the roflumilast group had events assessed as likely or definitely related to the study drug (21.5% vs 8.3%). CONCLUSIONS: This post-hoc, pooled analysis showed that roflumilast reduced exacerbation frequency in a subset of COPD patients whose characteristics included chronic bronchitis with/without concurrent ICS. These observations aided the design of subsequent phase 3 studies that prospectively confirmed the reduction in exacerbations with roflumilast treatment. TRIALS REGISTRATION: ClinicalTrials.gov identifiers: NCT00076089 and NCT00430729.|*Patient Selection[MESH]|Administration, Oral[MESH]|Aged[MESH]|Aminopyridines/administration & dosage/adverse effects/*therapeutic use[MESH]|Anti-Inflammatory Agents/administration & dosage/adverse effects/*therapeutic use[MESH]|Benzamides/administration & dosage/adverse effects/*therapeutic use[MESH]|Clinical Trials, Phase III as Topic[MESH]|Cyclopropanes/administration & dosage/adverse effects/therapeutic use[MESH]|Double-Blind Method[MESH]|Drug Administration Schedule[MESH]|Female[MESH]|Forced Expiratory Volume[MESH]|Humans[MESH]|Lung/*drug effects/enzymology/physiopathology[MESH]|Male[MESH]|Middle Aged[MESH]|Multicenter Studies as Topic[MESH]|Phosphodiesterase 4 Inhibitors/administration & dosage/adverse effects/*therapeutic use[MESH]|Proportional Hazards Models[MESH]|Pulmonary Disease, Chronic Obstructive/*drug therapy/enzymology/physiopathology[MESH]|Randomized Controlled Trials as Topic[MESH]|Research Design[MESH]|Risk Assessment[MESH]|Risk Factors[MESH]|Treatment Outcome[MESH] |
