Roflumilast Shows Some Benefit as an Add-On Therapy for COPD Patients with Frequent Exacerbations

Roflumilast (Daliresp), a selective phosphodiesterase-4 inhibitor, reduces the frequency of exacerbations in patients who have chronic obstructive pulmonary disease (COPD) with severe airflow limitation (forced expiratory volume in 1 second [FEV₁] ≤50% predicted). Whether it offers additional benefit in patients who are receiving optimal doses of long-acting β-agonists (LABAs), inhaled corticosteroids (ICSs), and long-acting muscarinic antagonists (LAMAs) is uncertain.

In an industry-funded study, 1945 patients with COPD and severe airflow obstruction were randomized to daily roflumilast (500 μg orally) or placebo and followed for 1 year. All patients had experienced >2 exacerbations during the previous year and continued their fixed dose LA…