alexa Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD.
Pulmonology

Pulmonology

Journal of Pulmonary & Respiratory Medicine

Author(s): Rennard SI, Calverley PM, Goehring UM, Bredenbrker D, Martinez FJ

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Abstract BACKGROUND: 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 μg 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.
This article was published in Respir Res and referenced in Journal of Pulmonary & Respiratory Medicine

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