Dataset Information

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 ?g once daily for 12 weeks or roflumilast 250 ?g once daily for 4 weeks, and then 500 ?g 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.

SUBMITTER: Park TS

PROVIDER: S-EPMC6580853 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Park Tai Sun TS Kang Jieun J Lee Jae Seung JS Oh Yeon-Mok YM Lee Sang-Do SD Lee Sei Won SW

International journal of chronic obstructive pulmonary disease 20190416

<h4>Background</h4>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.<h4>Methods</h4>This was a randomized, prospective, open-label, single-blind study to compare the adherence rate to roflumilast according to a dose-escalation or conventional do ...[more]

PMID: 31354255

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Project description:BackgroundRoflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein.MethodsIn this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures.ResultsAcross 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016.ConclusionThis study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment.

Dataset Information

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

Publications

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

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