The use of roflumilast in COPD: a primary care perspective

Abstract Therapeutic interventions in chronic obstructive pulmonary disease (COPD) shown to reduce exacerbations include smoking cessation,vaccination and appropriate pharmacological therapy. Long-acting bronchodilators are the cornerstone of COPD pharmacotherapy,whereas inhaled corticosteroids and mucolytics have shown benefit in subgroups of patients. Despite management with existingtherapies, clinical trials confirm the persistent nature of exacerbations throughout the course of the disease. Roflumilast – aphosphodiesterase-4 (PDE4) inhibitor – received European Marketing Approval in 2010 and represents a new class of drug in themanagement of COPD. Through selective inhibition of the PDE4 enzyme, roflumilast prevents the breakdown of cyclic AMP, which playsan important role in regulating inflammatory cell activity. Early trials in patients with a forced expiratory volume in one second (FEV1) lessthan 50% predicted suggest that roflumilast offers sustained and significant improvement in lung function and a reduction inexacerbations compared with placebo, irrespective of concomitant bronchodilator therapy. Common adverse events include headache,diarrhoea and weight loss, with the majority occurring at the beginning of treatment, being transient and not leading to sequelae. Seriousadverse events tended to be low across all studies. Roflumilast is currently licensed in Europe, and is indicated as maintenance treatmentin severe COPD (i.e. in patients with post-bronchodilator FEV1 <50% predicted) associated with chronic bronchitis in adult patients witha history of frequent exacerbations as an add-on to bronchodilator treatment. Clear identification of patients eligible for roflumilast willrequire improved characterisation and phenotyping of patients in primary care, including lung function measurement, accurate healthstatus classification, and recording of chronic cough and regular sputum production.© 2010 Primary Care Respiratory Society UK. All rights reserved.D Price