Yonsei Med J.  2016 Jul;57(4):928-935. 10.3349/ymj.2016.57.4.928.

Efficacy and Safety of Roflumilast in Korean Patients with COPD

• Lee JS
• Hong YK
• Park TS
• Lee SW
• Oh YM
• Lee SD

• KMID: 2374125
• DOI: http://doi.org/10.3349/ymj.2016.57.4.928

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.

Keyword

Chronic obstructive pulmonary disease; Korea; roflumilast; treatment efficacy; safety

MeSH Terms

Aged
Aminopyridines/*therapeutic use
*Asian Continental Ancestry Group
Benzamides/*therapeutic use
Cyclopropanes/therapeutic use
Double-Blind Method
Female
Humans
Male
Middle Aged
Phosphodiesterase 4 Inhibitors/*therapeutic use
Pulmonary Disease, Chronic Obstructive/*drug therapy/*ethnology/physiopathology
Republic of Korea
Respiratory Function Tests
Treatment Outcome
Aminopyridines
Benzamides
Cyclopropanes
Phosphodiesterase 4 Inhibitors

Figure

• 

  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 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.

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