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

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.

Authors+Show Affiliations

Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31354255

Citation

Park, Tai Sun, et al. "Adherence to Roflumilast Under Dose-escalation Strategy in Korean Patients With COPD." International Journal of Chronic Obstructive Pulmonary Disease, vol. 14, 2019, pp. 871-879.
Park TS, Kang J, Lee JS, et al. Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019;14:871-879.
Park, T. S., Kang, J., Lee, J. S., Oh, Y. M., Lee, S. D., & Lee, S. W. (2019). Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease, 14, pp. 871-879. doi:10.2147/COPD.S191033.
Park TS, et al. Adherence to Roflumilast Under Dose-escalation Strategy in Korean Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019;14:871-879. PubMed PMID: 31354255.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2019/04/16/ PY - 2019/7/30/entrez PY - 2019/7/30/pubmed PY - 2019/7/30/medline KW - COPD KW - adherence KW - roflumilast SP - 871 EP - 879 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 14 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. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/31354255/Adherence_to_roflumilast_under_dose-escalation_strategy_in_Korean_patients_with_COPD L2 - https://dx.doi.org/10.2147/COPD.S191033 DB - PRIME DP - Unbound Medicine ER -