Evidence map›Paper›PMID 31354255›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2019

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

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02018432 (Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.2field-weighted citation impact, top 44% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02018432 phase4unknown statusnot on this map

Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast

TypeinterventionalSponsorAsan Medical CenterRan2013 to 2015Enrolled80ConditionsChronic Obstructive Pulmonary DiseaseArmsRoflumilast escalation dosage, Roflumilast conventional dosage
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Tai Sun ParkDepartment of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.
Jieun KangDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.
Jae Seung LeeDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.
Yeon-Mok OhDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.
Sang-Do LeeDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.
Sei Won LeeDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, iseiwon@gmail.com.
Ulsan College · KRHanyang University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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, 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.

Indexed as

Medication AdherenceAgedAge FactorsAminopyridinesBenzamidesCyclopropanesFemaleHumansMalePhosphodiesterase 4 InhibitorsProspective StudiesPulmonary Disease, Chronic ObstructiveRisk FactorsSeoulSingle-Blind MethodTime FactorsAminopyridinesBenzamidesCyclopropanesPhosphodiesterase 4 InhibitorsRoflumilastadherenceCOPDroflumilast

Identifiers

PMID31354255
PMCPMC6580853
OpenAlexW2939720090

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.