TY - JOUR

T1 - Roflumilast: clinical benefit in patients suffering from COPD

AU - Ulrik, Charlotte Suppli

AU - Calverley, Peter Michael Anthony

N1 - © 2010 Blackwell Publishing Ltd.

PY - 2010

Y1 - 2010

N2 - BACKGROUND AND AIMS: Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality and is characterised by persistent airway inflammation, which leads to impaired airway function, quality of life and intermittent exacerbations. In spite of recent advances in the treatment of COPD, new treatment options for COPD are clearly necessary. The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast represents a new class of drugs that has shown efficacy and acceptable tolerability in preclinical and short-term clinical studies in patients with COPD. METHODS AND RESULTS: The available long-term clinical studies reviewed here suggest that the clinical efficacy of roflumilast is likely because of the suppression of airway inflammation and not through bronchodilation. Furthermore, the clinical studies have shown a modest improvement in airway function, including FEV(1) , and a reduction in frequency and severity of COPD exacerbations, as well as a positive effect on several patient-reported outcomes. The clinical benefit of roflumilast appears to be greatest in patients with more symptomatic and severe disease who experience exacerbations. The most common adverse effects are gastrointestinal events, primarily diarrhoea, nauseas and weight loss. CONCLUSION: Roflumilast is beneficial for maintenance treatment of patients with severe and symptomatic COPD and with a history of frequent acute exacerbations as an add-on to treatment with long-acting bronchodilators. It may have a role as an alternative to inhaled corticosteroids in more symptomatic COPD patients with frequent exacerbations, although direct comparisons are currently lacking.

AB - BACKGROUND AND AIMS: Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality and is characterised by persistent airway inflammation, which leads to impaired airway function, quality of life and intermittent exacerbations. In spite of recent advances in the treatment of COPD, new treatment options for COPD are clearly necessary. The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast represents a new class of drugs that has shown efficacy and acceptable tolerability in preclinical and short-term clinical studies in patients with COPD. METHODS AND RESULTS: The available long-term clinical studies reviewed here suggest that the clinical efficacy of roflumilast is likely because of the suppression of airway inflammation and not through bronchodilation. Furthermore, the clinical studies have shown a modest improvement in airway function, including FEV(1) , and a reduction in frequency and severity of COPD exacerbations, as well as a positive effect on several patient-reported outcomes. The clinical benefit of roflumilast appears to be greatest in patients with more symptomatic and severe disease who experience exacerbations. The most common adverse effects are gastrointestinal events, primarily diarrhoea, nauseas and weight loss. CONCLUSION: Roflumilast is beneficial for maintenance treatment of patients with severe and symptomatic COPD and with a history of frequent acute exacerbations as an add-on to treatment with long-acting bronchodilators. It may have a role as an alternative to inhaled corticosteroids in more symptomatic COPD patients with frequent exacerbations, although direct comparisons are currently lacking.

U2 - http://dx.doi.org/10.1111/j.1752-699X.2010.00224.x

DO - http://dx.doi.org/10.1111/j.1752-699X.2010.00224.x

M3 - Journal article

VL - 4

SP - 197

EP - 201

JO - Clinical Respiratory Journal

JF - Clinical Respiratory Journal

SN - 1752-6981

IS - 4

ER -