01 March 2017 by Namita Sood

Effects of riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) versus persistent/recurrent pulmonary hypertension (PH) after pulmonary endarterectomy (PEA): 2-year efficacy results from the CHEST-2 study

Introduction

CHEST-2 showed riociguat to be the first therapy to have sustained clinical effect in patients with CTEPH. We compared inoperable CTEPH and persistent/recurrent PH subgroup data from the final CHEST-2 datacut.

Methods

Patients with inoperable CTEPH or persistent/recurrent PH after PEA who completed the 16-week CHEST-1 study without ongoing riociguat-related SAEs were eligible to enter CHEST-2. All patients received riociguat up to 2.5 mg tid. Primary endpoints were safety and tolerability; secondary endpoints included 6MWD and WHO FC.

Results

In total, 237 patients entered CHEST-2; 172 (73%) had inoperable CTEPH and 65 (27%) had persistent/recurrent PH. At the data cutoff (March 2014), 172 patients (73%) were ongoing. Median treatment duration was 116 weeks and 90% of patients remained on riociguat monotherapy. Improvements in 6MWD in the inoperable subgroup were more pronounced than in the persistent/recurrent subgroup, while improvements in WHO FC were similar (Table 1). Improvements in NT-proBNP, EQ-5D, and Borg dyspnea scores were also observed in both subgroups (Table 1). There were similar rates of AEs (99% vs 97%), and clinical worsening (22% vs 23%) in the inoperable vs persistent/recurrent PH subgroups, respectively. There were fewer SAEs in the inoperable vs persistent/recurrent PH subgroup (52% vs 62%), and higher survival (94% vs 89%).

Conclusions

Riociguat provided long-term clinical benefit in both inoperable CTEPH and persistent/recurrent PH after PEA, with good tolerability at 2 years. The improvements in 6MWD and WHO FC observed with riociguat treatment in CHEST-1 were sustained at 2 years in CHEST-2 in both subgroups.

Key Contributors

Kim Kerr, 1 Marius M Hoeper, 2 Namita Sood, 3 Adam Torbicki, 4 Arno Fritsch, 5 Janethe de Oliveira Pena, 6 Hossein-Ardeschir Ghofrani7, 8 1Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, USA; 2Clinic for Respiratory Medicine, Hannover Medical School, Hannover, Germany, member of the German Center of Lung Research (DZL); 3Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio, USA; 4Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center of Postgraduate Education, ECZ-Otwock, Otwock, Poland; 5Global Clinical Development, Bayer Pharma AG, Wuppertal, Germany; 6Global Development, Bayer HealthCare Pharmaceuticals Inc., Whippany, New Jersey, USA; 7University of Giessen and Marburg Lung Center, Giessen, Germany, member of the German Center for Lung Research (DZL); 8Department of Medicine, Imperial College London, London, UK.


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