RESPITE: Switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors

Marius M. Hoeper, Gérald Simonneau, Paul A. Corris, Hossein Ardeschir Ghofrani, James R. Klinger, David Langleben, Robert Naeije, Pavel Jansa, Stephan Rosenkranz, Laura Scelsi, Ekkehard Grünig, Carmine Dario Vizza, Mikyung Chang, Pablo Colorado, Christian Meier, Dennis Busse, Raymond L. Benza

Research output: Contribution to journalArticle

Abstract

A proportion of pulmonary arterial hypertension (PAH) patients do not reach treatment goals with phosphodiesterase-5 inhibitors (PDE5i). RESPITE investigated the safety, feasibility and benefit of switching from PDE5i to riociguat in these patients. RESPITE was a 24-week, open-label, multicentre, uncontrolled study. Patients in World Health Organization (WHO) functional class (FC) III, with 6-min walking distance (6MWD) 165-440 m, cardiac index <3.0 L min-1 m-2 and pulmonary vascular resistance >400 dyn s cm-5 underwent a 1-3 day PDE5i treatmentfree period before receiving riociguat adjusted up to 2.5 mg maximum t.i.d. Exploratory end-points included change in 6MWD, WHO FC, N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and safety. Of 61 patients enrolled, 51 (84%) completed RESPITE. 50 (82%) were receiving concomitant endothelin receptor antagonists. At week 24, mean±SD 6MWD had increased by 31±63 m, NT-proBNP decreased by 347±1235 pg mL-1 and WHO FC improved in 28 patients (54%). 32 patients (52%) experienced study drug-related adverse events and 10 (16%) experienced serious adverse events (2 (3%) study drug-related, none during the PDE5i treatment-free period). Six patients (10%) experienced clinical worsening, including death in two (not study drug-related). In conclusion, selected patients with PAH may benefit from switching from PDE5i to riociguat, but this strategy needs to be further studied.

Original languageEnglish
Article number02425
JournalEuropean Respiratory Journal
Volume50
Issue number3
DOIs
Publication statusPublished - Sep 1 2017

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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    Hoeper, M. M., Simonneau, G., Corris, P. A., Ghofrani, H. A., Klinger, J. R., Langleben, D., Naeije, R., Jansa, P., Rosenkranz, S., Scelsi, L., Grünig, E., Vizza, C. D., Chang, M., Colorado, P., Meier, C., Busse, D., & Benza, R. L. (2017). RESPITE: Switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors. European Respiratory Journal, 50(3), [02425]. https://doi.org/10.1183/13993003.02425-2016