SOURCE: Martinez FJ, et al. Lancet 2015;385:857-866
Acute exacerbations of COPD (AE-COPD) are potentially highly consequential: in-hospital mortality is approximately 10%, and up to 25% of patients admitted to the ICU die. Additionally, AE-COPD is associated with a decline in pulmonary function that is not regained once the exacerbation is resolved. Fortunately, several of the tools we use to treat COPD are associated with reduced frequency of exacerbations.
Roflumilast (ROF) is a PDE-4 inhibitor that has been shown to reduce AE-COPD and has FDA labeling for that indication. Martinez et al have published the results of their multicenter randomized, double-blind, placebo-controlled trial that sought to determine whether ROF reduces exacerbations compared to placebo in severe COPD patients who are already on background combination therapy of inhaled long-acting beta-agonist plus inhaled corticosteroid (n = 1945).
After one year of treatment, the rate of AE-COPD was statistically significantly lower in persons who were treated with ROF than placebo. The adverse events rates were similar in the ROF and placebo groups. Additionally, hospital admissions for AE-COPD were significantly reduced in the ROF group vs placebo. The addition of ROF to the regimen of patients with severe COPD already using combination therapy with beta-agonists and inhaled corticosteroids can reduce exacerbations and hospitalizations related to exacerbations.