Adherence to roflumilast under dose-escalation strategy in korean patients with COPD

Tai Sun Park, Jieun Kang, Jae Seung Lee, Yeon Mok Oh, Sang Do Lee, Sei Won Lee

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: Frequent development of adverse events and consequent low adherence are major barriers in the wide use of roflumilast. Asian patients may be more susceptible to adverse events due to low BMI. In this study, we aimed to determine if a dose-escalation strategy is useful to improve the drug adherence rate. Methods: This was a randomized, prospective, open-label, single-blind study to compare the adherence rate to roflumilast according to a dose-escalation or conventional dose strategy in patients with COPD in South Korea. Patients were randomized into two groups (1:1), either roflumilast 500 μg once daily for 12 weeks or roflumilast 250 μg once daily for 4 weeks, and then 500 μg for 12 weeks. The primary outcome was the percentage of patients prematurely discontinuing roflumilast due to adverse events. Results: A total of 55 patients were randomly assigned to either a conventional-dose group (n=28) or a dose-escalation group (n=27). Discontinuation rates of roflumilast due to adverse events were 46.4% for the conventional-dose group and 59.3% for the dose-escalation group. The median time to discontinuation was not different between groups (58 days for the conventional-dose group, 56 days for the dose-escalation group, p=0.629). In a multivariate analysis, older age was a significant risk factor for drug discontinuation. Conclusion: High discontinuation rates of roflumilast were observed in both groups regardless of the dose-escalation strategy. The frequent discontinuation suggests that the dose-escalation strategy may not be useful in Asian patients. Clinical trial: This study is registered at www.ClinicalTrials.gov with identifier number NCT02018432.

Original languageEnglish
Pages (from-to)871-879
Number of pages9
JournalInternational Journal of COPD
Volume14
DOIs
StatePublished - 2019 Jan 1

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Chronic Obstructive Pulmonary Disease
Single-Blind Method
Republic of Korea
Roflumilast
Pharmaceutical Preparations
Multivariate Analysis
Clinical Trials

Keywords

  • Adherence
  • COPD
  • Roflumilast

Cite this

Park, Tai Sun ; Kang, Jieun ; Lee, Jae Seung ; Oh, Yeon Mok ; Lee, Sang Do ; Lee, Sei Won. / Adherence to roflumilast under dose-escalation strategy in korean patients with COPD. In: International Journal of COPD. 2019 ; Vol. 14. pp. 871-879.
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abstract = "Background: Frequent development of adverse events and consequent low adherence are major barriers in the wide use of roflumilast. Asian patients may be more susceptible to adverse events due to low BMI. In this study, we aimed to determine if a dose-escalation strategy is useful to improve the drug adherence rate. Methods: This was a randomized, prospective, open-label, single-blind study to compare the adherence rate to roflumilast according to a dose-escalation or conventional dose strategy in patients with COPD in South Korea. Patients were randomized into two groups (1:1), either roflumilast 500 μg once daily for 12 weeks or roflumilast 250 μg once daily for 4 weeks, and then 500 μg for 12 weeks. The primary outcome was the percentage of patients prematurely discontinuing roflumilast due to adverse events. Results: A total of 55 patients were randomly assigned to either a conventional-dose group (n=28) or a dose-escalation group (n=27). Discontinuation rates of roflumilast due to adverse events were 46.4{\%} for the conventional-dose group and 59.3{\%} for the dose-escalation group. The median time to discontinuation was not different between groups (58 days for the conventional-dose group, 56 days for the dose-escalation group, p=0.629). In a multivariate analysis, older age was a significant risk factor for drug discontinuation. Conclusion: High discontinuation rates of roflumilast were observed in both groups regardless of the dose-escalation strategy. The frequent discontinuation suggests that the dose-escalation strategy may not be useful in Asian patients. Clinical trial: This study is registered at www.ClinicalTrials.gov with identifier number NCT02018432.",
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Adherence to roflumilast under dose-escalation strategy in korean patients with COPD. / Park, Tai Sun; Kang, Jieun; Lee, Jae Seung; Oh, Yeon Mok; Lee, Sang Do; Lee, Sei Won.

In: International Journal of COPD, Vol. 14, 01.01.2019, p. 871-879.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Adherence to roflumilast under dose-escalation strategy in korean patients with COPD

AU - Park, Tai Sun

AU - Kang, Jieun

AU - Lee, Jae Seung

AU - Oh, Yeon Mok

AU - Lee, Sang Do

AU - Lee, Sei Won

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Frequent development of adverse events and consequent low adherence are major barriers in the wide use of roflumilast. Asian patients may be more susceptible to adverse events due to low BMI. In this study, we aimed to determine if a dose-escalation strategy is useful to improve the drug adherence rate. Methods: This was a randomized, prospective, open-label, single-blind study to compare the adherence rate to roflumilast according to a dose-escalation or conventional dose strategy in patients with COPD in South Korea. Patients were randomized into two groups (1:1), either roflumilast 500 μg once daily for 12 weeks or roflumilast 250 μg once daily for 4 weeks, and then 500 μg for 12 weeks. The primary outcome was the percentage of patients prematurely discontinuing roflumilast due to adverse events. Results: A total of 55 patients were randomly assigned to either a conventional-dose group (n=28) or a dose-escalation group (n=27). Discontinuation rates of roflumilast due to adverse events were 46.4% for the conventional-dose group and 59.3% for the dose-escalation group. The median time to discontinuation was not different between groups (58 days for the conventional-dose group, 56 days for the dose-escalation group, p=0.629). In a multivariate analysis, older age was a significant risk factor for drug discontinuation. Conclusion: High discontinuation rates of roflumilast were observed in both groups regardless of the dose-escalation strategy. The frequent discontinuation suggests that the dose-escalation strategy may not be useful in Asian patients. Clinical trial: This study is registered at www.ClinicalTrials.gov with identifier number NCT02018432.

AB - Background: Frequent development of adverse events and consequent low adherence are major barriers in the wide use of roflumilast. Asian patients may be more susceptible to adverse events due to low BMI. In this study, we aimed to determine if a dose-escalation strategy is useful to improve the drug adherence rate. Methods: This was a randomized, prospective, open-label, single-blind study to compare the adherence rate to roflumilast according to a dose-escalation or conventional dose strategy in patients with COPD in South Korea. Patients were randomized into two groups (1:1), either roflumilast 500 μg once daily for 12 weeks or roflumilast 250 μg once daily for 4 weeks, and then 500 μg for 12 weeks. The primary outcome was the percentage of patients prematurely discontinuing roflumilast due to adverse events. Results: A total of 55 patients were randomly assigned to either a conventional-dose group (n=28) or a dose-escalation group (n=27). Discontinuation rates of roflumilast due to adverse events were 46.4% for the conventional-dose group and 59.3% for the dose-escalation group. The median time to discontinuation was not different between groups (58 days for the conventional-dose group, 56 days for the dose-escalation group, p=0.629). In a multivariate analysis, older age was a significant risk factor for drug discontinuation. Conclusion: High discontinuation rates of roflumilast were observed in both groups regardless of the dose-escalation strategy. The frequent discontinuation suggests that the dose-escalation strategy may not be useful in Asian patients. Clinical trial: This study is registered at www.ClinicalTrials.gov with identifier number NCT02018432.

KW - Adherence

KW - COPD

KW - Roflumilast

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U2 - 10.2147/COPD.S191033

DO - 10.2147/COPD.S191033

M3 - Article

VL - 14

SP - 871

EP - 879

JO - International Journal of COPD

JF - International Journal of COPD

SN - 1176-9106

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