01 March 2017 by John McConnell

Effects of riociguat in treatment-naïve vs pretreated patients with pulmonary arterial hypertension (PAH): 2-year efficacy results from the PATENT-2 study

Introduction

Riociguat showed sustained efficacy in patients with PAH in the PATENT-2 study. We compared treatment-naïve and pretreated patients from the final datacut of PATENT-2.

Methods

Patients with PAH who were treatment-naïve or pretreated with ERAs or prostanoids entered PATENT-2 after completing PATENT-1 without ongoing riociguat-related SAEs. All patients received riociguat individually adjusted up to a maximum of 2.5 mg tid. Primary endpoints were safety and tolerability; secondary endpoints included 6MWD, WHO FC, survival, and clinical worsening-free survival.

Results

In total, 396 patients entered PATENT-2; 197 (50%) were treatment-naïve and 199 (50%) were pretreated. Median treatment duration was >2 years (139 weeks). Of the treatment-naïve patients who reached 2 years (n=141), 24 (17%) had initiated concomitant therapy with ERAs and/or prostanoids. Improvements in 6MWD, NT-proBNP, Borg dyspnea score, and EQ-5D were more pronounced in the treatment-naïve subgroup compared with the pretreated subgroup (Table 1). The most frequent AEs in the treatment-naïve and pretreated subgroups were nasopharyngitis (27% vs 33%), dizziness (25% vs 26%), and peripheral edema (21% vs 28%). Fewer patients in the treatment-naïve subgroup compared with the pretreated subgroup experienced SAEs (52% vs 68%), drug-related SAEs (7% vs 13%), clinical worsening (25% vs 29%), and death (11% vs 14%).

Conclusions

Riociguat provided long-term clinical benefit in treatment-naïve and pretreated patients with PAH. No new safety signals identified, but more SAEs were observed in the pretreated subgroup. The improvements in 6MWD and WHO FC observed with riociguat treatment in PATENT-1 were sustained at 2 years in PATENT-2 in both subgroups.

About the author


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John McConnell

Director, Pulmonary Hypertension, Center of Comprehensive Care

Kentuckiana Pulmonary Associates

United States

Key Contributors

John McConnell, 1 Peter Engel, 2 Franz Rischard, 3 Stephan Rosenkranz, 4 Carmine Dario Vizza, 5 Arno Fritsch, 6 Janethe de Oliveira Pena, 7 Hossein-Ardeschir Ghofrani8, 9 1Division of Pulmonary and Critical Care Medicine, University of Kentucky Medical Center, Kentucky, USA; 2Ohio Heart and Cardiovascular Center, The Christ Hospital, Cincinnati, Ohio, USA; 3Division of Pulmonary, Critical Care, Sleep and Allergy Medicine, Department of Medicine, the University of Arizona College of Medicine, Tucson, Arizona, USA; 4Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany; 5La Sapienza University of Rome, Rome, Italy; 6Bayer Pharma AG, Wuppertal, Germany; 7Bayer HealthCare Pharmaceuticals Inc., Whippany, New Jersey, USA; 8University of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany, and Member of the German Center of Lung Research (DZL); 9Department of Medicine, Imperial College London, London, UK


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