Incidence of Adverse Effects and Discontinuation Rate between Patients Receiving 250 Micrograms and 500 Micrograms of Roflumilast: A Comparative Study

BACKGROUND: Roflumilast is the only approved oral phosphodiesterase-4 inhibitor for the treatment of severe chronic obstructive pulmonary disease (COPD) in patients with chronic bronchitis and a history of frequent exacerbations. The purpose of this study was to examine the incidence of adverse effects associated with roflumilast treatment in a real-world setting. Further, we compared the incidence of adverse effects and the discontinuation rate among patients receiving different doses. METHODS: We identified all outpatients diagnosed with COPD at Seoul St. Mary's Hospital between May 2011 and September 2016 and retrospectively reviewed their medical records. Roflumilast was prescribed to patients in doses of 500 µg and 250 µg. RESULTS: A total of 269 COPD patients were prescribed roflumilast in our hospital during the study period. Among them, 178 patients were treated with 500 µg and 91 patients were treated with 250 µg. The incidence of adverse effects was 38.2% in the 500 µg group and 25.3% in the 250 µg group (p=0.034). The discontinuation rate of roflumilast was 41.6% (n=74) in the 500 µg group and 23.1% (n=21) in the 250 µg group (p=0.003). When adjusted by age, sex, smoking status, and lung function, 500 µg dose was significantly associated with the discontinuation of roflumilast (odds ratio, 2.87; p<0.001). CONCLUSION: There was a lower incidence of adverse effects and discontinuation among patients treated with 250 µg compared with 500 µg dose. Further studies regarding the optimal dose of roflumilast are required.