Watz, Henrik, Bagul, Nitin, Rabe, Klaus F, Rennard, Stephen, Alagappan, Vijay KT, Roman, Jonas, Facius, Axel and Calverley, Peter MA
(2018)
Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD.
INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, 13.
pp. 813-822.
Text
Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD.pdf - Published version Download (1MB) | Preview |
Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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], <i>p</i>=0.017) and lower rates of AEs of interest such as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain (OR 0.63 [95% CI 0.47-0.83], <i>p</i>=0.001) compared with those in the 500 µg OD group. Although rates of discontinuation and AEs of interest were numerically lower with ROF 500 µg EOD/500 µg OD, the difference was not significant (OR 0.76, <i>p</i>=0.114, and OR 0.78, <i>p</i>=0.091, respectively) compared with ROF 500 µg OD.<h4>Conclusion</h4>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.
Item Type: | Article |
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Uncontrolled Keywords: | roflumilast, COPD, discontinuation, adverse event |
Depositing User: | Symplectic Admin |
Date Deposited: | 13 Aug 2019 09:09 |
Last Modified: | 19 Jan 2023 00:31 |
DOI: | 10.2147/COPD.S154012 |
Related URLs: | |
URI: | https://livrepository.liverpool.ac.uk/id/eprint/3051535 |