Efficacy and Safety of Roflumilast in Korean Patients with COPD |
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| Authors: | Jae Seung Lee Yoon Ki Hong Tae Sun Park Sei Won Lee Yeon-Mok Oh Sang-Do Lee |
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| Affiliation: | 1Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.;2Department of Internal Medicine, Kangwon National University College of Medicine, Chuncheon, Korea. |
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| Abstract: | ![]()
PurposeRoflumilast is the only oral phosphodiesterase 4 inhibitor approved to treat chronic obstructive pulmonary disease (COPD) patients [post-bronchodilator forced expiratory volume in 1 second (FEV1) <50% predicted] with chronic bronchitis and a history of frequent exacerbations. This study evaluated the efficacy and safety of roflumilast in Korean patients with COPD and compared the efficacy based on the severity of airflow limitation.ResultsA total of 260 Korean COPD patients were recruited, of which 207 were randomized to roflumilast (n=102) or placebo (n=105) treatment. After 12 weeks, LSMean post-bronchodilator FEV1 increased by 43 mL for patients receiving roflumilast and decreased by 60 mL for those taking placebo. Adverse events were more common in the roflumilast group than in the placebo group; however, the types and frequency of AEs were comparable to those reported in previous studies.ConclusionRoflumilast significantly improved lung function with a tolerable safety profile in Korean COPD patients irrespective of the severity of airflow limitation. |
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| Keywords: | Chronic obstructive pulmonary disease Korea roflumilast treatment efficacy safety |
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