Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2016 Jul;57(4):928-35.
doi: 10.3349/ymj.2016.57.4.928.

Efficacy and Safety of Roflumilast in Korean Patients with COPD

Jae Seung Lee  1 , Yoon Ki Hong  2 , Tae Sun Park  1 , Sei Won Lee  1 , Yeon Mok Oh  1 , Sang Do Lee  3
Affiliations
Clinical Trial

Efficacy and Safety of Roflumilast in Korean Patients with COPD

Jae Seung Lee et al. Yonsei Med J. 2016 Jul.

Abstract

Purpose: Roflumilast 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.

Materials and methods: A post-hoc subgroup analysis was performed in Korean COPD patients participating in JADE, a 12-week, double-blinded, placebo-controlled, parallel-group, phase III trial in Asia. The primary efficacy endpoint was the mean [least-squares mean adjusted for covariates (LSMean)] change in post-bronchodilator FEV₁ from baseline to each post-randomization visit. Safety endpoints included adverse events (AEs) and changes in laboratory values, vital signs, and electrocardiograms.

Results: A 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.

Conclusion: Roflumilast significantly improved lung function with a tolerable safety profile in Korean COPD patients irrespective of the severity of airflow limitation.

Keywords: Chronic obstructive pulmonary disease; Korea; roflumilast; safety; treatment efficacy.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest statement: The authors have no financial conflicts of interest.

YM Oh received payment for lecturing from MSD Korea, AstraZeneca Korea, Boehringer Ingelheim Korea, Novartis, DongWha, Takeda, and GSK Korea. SD Lee received support from Takeda Pharmaceuticals International GmbH for travel to an investigator meeting. He received payment from Takeda Pharmaceuticals International GmbH for attendance at an advisory board. He also received honoraria from GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim.

Figures

Fig. 1
Fig. 1. Disposition of Korean COPD patients in the JADE study. *Some patients had more than one reason reported for discontinuing treatment. Discontinuation reasons are given as specified at the termination of the study. COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; ITT, intention-to-treat; PP, per protocol.
Fig. 2
Fig. 2. Pre- and post-bronchodilator mean (SE) FEV1 values from baseline to last visit (last observation carried forward) with roflumilast and placebo for (A) all Korean COPD patients, (B) Korean COPD patients with FEV1 ≤60% predicted, and (C) Korean COPD patients with FEV1 60–80% predicted. SE, standard error; FEV1, forced expiratory volume in 1 second; COPD, chronic obstructive pulmonary disease.
See this image and copyright information in PMC

References

    1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3:e442. - PMC - PubMed
    1. Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006;27:397–412. - PubMed
    1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. [updated 2014]. [accessed on 2015 May]. Available at: http://www.goldcopd.org/uploads/users/les/GOLD_Report2014_Feb07.pdf. - PubMed
    1. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775–789. - PubMed
    1. Drummond MB, Dasenbrook EC, Pitz MW, Murphy DJ, Fan E. Inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA. 2008;300:2407–2416. - PMC - PubMed

Publication types