Roflumilast is an oral phosphodiesterase-4 inhibitor indicated to reduce risk of chronic obstructive pulmonary disease (COPD) exacerbations in severe COPD patients with chronic bronchitis and a history of exacerbations. While use of an inhaled corticosteroid + long-acting beta2-agonist (LABA) is recommended for long-term maintenance treatment of airflow obstruction in COPD, the efficacy of roflumilast as an add-on treatment to these medications as maintenance therapy is unknown.

A one-year, double-blind, placebo-controlled, parallel-group, multicenter study enrolled 2,708 patients ≥40 years with a smoking history of at least 20 pack-years, a confirmed diagnosis of COPD with severe airflow limitation, symptoms of chronic bronchitis, and a history of at least two exacerbations in the previous year. All patients were required to be taking a constant dose of an inhaled corticosteroid + LABA for at least three months prior to enrollment in the study. A single-blind, four week run-in period in which all patients received a placebo tablet in addition to their inhaled corticosteroid + LABA (and if relevant, tiotropium) was conducted. This was followed by 52-week treatment period of patients receiving either one 500mcg tablet/day of roflumilast or placebo. The primary endpoint was rate of moderate-to-severe COPD exacerbations per patient per year.

The patients taking roflumilast had a 13.2% lower rate of moderate-to-severe COPD exacerbations vs. the placebo group using a Poisson regression analysis and a 14.2% lower rate using a negative binomial regression. Compared with placebo, use of roflumilast led to a 24.3% reduction in severeevents and a reduction of 23.9% in exacerbations requiring hospitalization, regardless of use of long-acting muscarinic antagonists.

The results of this study could help clinicians in developing treatment plans for patients with COPD, particularly those at risk for exacerbations despite recommended inhaled therapy.

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