Journal Article

Haemodynamic effects of riociguat in inoperable/recurrent chronic thromboembolic pulmonary hypertension

Kim, Nick H, Grünig, Ekkehard, Mayer, Eckhard, Davie, Neil, Jansa, Pavel, Torbicki, Adam, Fritsch, Arno, Ghofrani, Hossein-Ardeschir, D'Armini, Andrea M, Neurohr, Claus, Wang, Chen, Hoeper, Marius M, Simonneau, Gérald, Grimminger, Friedrich

2017

Overview

ObjectiveWe compared the haemodynamic effects of riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent/recurrent CTEPH after pulmonary endarterectomy in the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial 1 study.MethodsPatients with inoperable or persistent/recurrent CTEPH (n=261; mean± SD age 59±14 years; 66% women) were randomised to riociguat (up to 2.5 mg three times daily) or placebo. Haemodynamic parameters were assessed at baseline and week 16.ResultsRiociguat decreased pulmonary vascular resistance (PVR) in inoperable (n=189; least-squares mean difference: −285 dyn s/cm5 (95% CI −357 to −213); p<0.0001) and persistent/recurrent (n=72; −131 dyn s/cm5 (95% CI −214 to −48); p=0.0025) patients. Cardiac index improved in inoperable patients by a least-squares mean difference of +0.6 L/min/m2 (95% CI 0.4 to 0.7; p<0.0001), while in persistent/recurrent patients the change was +0.2 L/min/m2 (95% CI −0.1 to 0.5; p=0.17). Mean pulmonary artery pressure decreased in inoperable and persistent/recurrent patients(−4.7 mm Hg (95% CI −6.9 to −2.6; p<0.0001 and −4.8 mm Hg (–8.2 to −1.5; p=0.0055), respectively). For all patients, changes in 6 min walk distance correlated with changes in PVR (r=−0.29 (95% CI −0.41 to −0.17); p<0.0001) and cardiac index (r=0.23 (95% CI 0.10 to 0.35); p=0.0004).ConclusionsRiociguat improved haemodynamics in patients with inoperable CTEPH or persistent/recurrent CTEPH.Trial registration numberNCT00855465.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Aged / Analysis of covariance / Antihypertensive Agents - adverse effects / Antihypertensive Agents - therapeutic use / Arterial Pressure - drug effects / Chronic Disease / Double-Blind Method / Drug therapy / Endarterectomy / Exercise Tolerance - drug effects / Female / Hemodynamics / Humans / Hypertension, Pulmonary - diagnosis / Hypertension, Pulmonary - drug therapy / Hypertension, Pulmonary - etiology / Hypertension, Pulmonary - physiopathology / Hypotension / Least-Squares Analysis / Male / Middle Aged / Patients / Prospective Studies / Pulmonary arteries / Pulmonary Artery - drug effects / Pulmonary Artery - physiopathology / Pulmonary Embolism - complications / Pulmonary Embolism - diagnosis / Pulmonary hypertension / Pulmonary Vascular Disease / Pyrazoles - adverse effects / Pyrazoles - therapeutic use / Pyrimidines - adverse effects / Pyrimidines - therapeutic use / Recovery of Function / Recurrence / Statistical analysis / Thromboembolism / Time Factors / Treatment Outcome / Vascular Resistance - drug effects / Walk Test