TY - JOUR
T1 - RESPITE
T2 - Switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors
AU - Hoeper, Marius M.
AU - Simonneau, Gérald
AU - Corris, Paul A.
AU - Ghofrani, Hossein Ardeschir
AU - Klinger, James R.
AU - Langleben, David
AU - Naeije, Robert
AU - Jansa, Pavel
AU - Rosenkranz, Stephan
AU - Scelsi, Laura
AU - Grünig, Ekkehard
AU - Vizza, Carmine Dario
AU - Chang, Mikyung
AU - Colorado, Pablo
AU - Meier, Christian
AU - Busse, Dennis
AU - Benza, Raymond L.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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.
AB - 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.
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U2 - 10.1183/13993003.02425-2016
DO - 10.1183/13993003.02425-2016
M3 - Article
AN - SCOPUS:85030026397
VL - 50
JO - European Respiratory Journal
JF - European Respiratory Journal
SN - 0903-1936
IS - 3
M1 - 02425
ER -