Document Type
Article
Journal Title
International Journal of Chronic Obstructive Pulmonary Disease
Publication Date
2018
Volume
13
Abstract
BACKGROUND: The oral selective phosphodiesterase-4 inhibitor roflumilast (ROF) reduces exacerbations in patients with severe COPD. Adverse events (AEs) can cause early ROF discontinuation. Alternative dosing strategies may help patients continue their therapy.
METHODS: In this multicenter, double-blind trial, 1,321 patients with severe COPD were randomized 1:1:1 to 4 weeks' treatment with ROF 250 µg once daily (OD), 500 µg every other day (EOD), or 500 µg OD, each followed by ROF 500 µg OD for 8 weeks, plus standard therapy. The primary end point was the percentage of patients prematurely discontinuing study treatment.
RESULTS: Patients in the 250 µg OD/500 µg OD group had significantly fewer treatment discontinuations (odds ratio [OR] 0.66 [95% CI 0.47-0.93],
CONCLUSION: A dose of ROF 250 µg OD for 4 weeks before escalation to the approved maintenance dose of 500 µg OD resulted in reduced treatment discontinuation and improved tolerability.
MeSH Headings
Aged, Aminopyridines, Benzamides, Cyclopropanes, Disease Progression, Double-Blind Method, Drug Administration Schedule, Drug Dosage Calculations, Female, Humans, Logistic Models, Lung, Male, Middle Aged, Odds Ratio, Phosphodiesterase 4 Inhibitors, Pulmonary Disease, Chronic Obstructive, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome
DOI Link
ISSN
1178-2005
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Recommended Citation
Watz, Henrik; Bagul, Nitin; Rabe, Klaus F.; Rennard, Stephen I.; Alagappan, Vijay Kt; Román, Jonas; Facius, Axel; and Calverley, Peter Ma, "Use of a 4-Week Up-Titration Regimen of Roflumilast in Patients with Severe COPD" (2018). Journal Articles: Pulmonary & Critical Care Med. 44.
https://digitalcommons.unmc.edu/com_pulm_articles/44
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