Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD



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.

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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
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