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

Tuberculosis and Respiratory Diseases

article

Hyonsoo Joo¹  Deokjae Han¹  Jae Ha Lee²  Chin Kook Rhee¹ 

[1] Division of Pulmonary, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea;Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine

关键词: Pulmonary Disease;    Chronic Obstructive;    Roflumilast;    Adverse Effects;    Safety;   

DOI  :  10.4046/trd.2018.0015

学科分类：医学（综合）

来源: The Korean Academy of Tuberculosis and Respiratory Diseases

【 摘 要 】

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.

【 授权许可】

CC BY-NC