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Effects of roflumilast on arterial stiffness in COPD ( ELASTIC ): A randomized trial
Author(s) -
Urban Matthias H.,
Kreibich Nicole,
Gleiss Andreas,
Funk GeorgChristian,
Hartl Sylvia,
Burghuber Otto C.
Publication year - 2021
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/resp.13914
Subject(s) - roflumilast , medicine , copd , pulse wave velocity , arterial stiffness , placebo , systemic inflammation , cardiology , randomized controlled trial , gastroenterology , inflammation , blood pressure , pathology , alternative medicine
Background and objective Cardiovascular risk is substantially increased in patients with COPD and can be quantified via arterial stiffness. The PDE‐IV inhibitor roflumilast revealed a potential reduction of COPD‐related cardiovascular risk. We aimed to investigate the effects of roflumilast on arterial stiffness by quantification of pulse wave velocity (PWV) in stable COPD. Methods In this randomized placebo‐controlled trial, 80 COPD patients received roflumilast or placebo for 24 weeks. The primary outcome was the change in cf‐PWV. Secondary outcomes comprised markers of vascular function (e.g. Aix and RHI), systemic inflammation (e.g. IL‐6 and TNF‐α) and clinical characteristics of COPD (e.g. CAT and 6MWT). Results A total of 33 and 34 patients completed the roflumilast and placebo arm, respectively (age, median (IQR): 64.5 (61–69.5) vs 64.5 (56–72) years; FEV 1 , median (IQR): 34.5 (25.5–48.6) vs 35.3 (27–46.8) % predicted; 6MWT, median (IQR): 428 (340–558) vs 456 (364–570) m). Change from baseline PWV did not show a significant difference between roflumilast and placebo (+5.0 (95% CI: −2.0 to +13.0) vs 0.0 (95% CI: −7.0 to +7.0)%, P = 0.268). Roflumilast did not improve markers of vascular function or systemic inflammation. We observed a significant improvement in change from baseline 6MWT with roflumilast versus placebo (+53.0 (95% CI: +19.1 to +86.9) vs −0.92 (95% CI: −35.1 to +33.3) m, P = 0.026). Conclusion Our study revealed no beneficial effects of roflumilast on arterial stiffness. Further studies are needed to test a potential improvement of exercise capacity with roflumilast in COPD.