17 Feb Effects of Riociguat in Treatment-Naïve vs Pretreated Patients With Pulmonary Arterial Hypertension

MedicalResearch.com Interview with:

Prof. Ghofrani

Prof. Hossein-Ardeschir Ghofrani
University of Giessen and Marburg Lung Center
Giessen, Germany, and
Member of the German Center of Lung Research
and Department of Medicine
Imperial College London
London, UK

MedicalResearch.com: What is the background for this study?

Response: Pulmonary arterial hypertension (PAH) is characterised by increased pulmonary vascular resistance (increased resistance to blood flow in the pulmonary circulation), which can lead to right heart failure and death. Riociguat is the first of a new class of drugs – the soluble guanylate cyclase stimulators. It has been approved for the treatment of PAH based on the impressive efficacy and safety results from two pivotal Phase III studies: PATENT-1 and its long-term extension phase, PATENT-2. PATENT-1 was a 12-week, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of riociguat in patients with PAH. Patients who completed PATENT-1 without ongoing riociguat-related serious adverse events (AEs) could enter PATENT-2, in which they received open-label riociguat. PATENT-1 admitted patients whether they were treatment-naïve or already receiving targeted PAH therapies, such as endothelin receptor antagonists (ERAs) and prostanoids. This current analysis compared the safety and efficacy of riociguat between treatment-naïve and pretreated patients in the PATENT-2 long-term extension study.

MedicalResearch.com: What are the main findings?

Response: At the time of this analysis, most patients had received at least 2 years of riociguat treatment. Of the 396 patients in PATENT-2, 197 (50%) were treatment-naïve and 199 (50%) were pretreated. Baseline characteristics were generally similar between the two subgroups. The data showed a similar safety profile for both groups with slightly higher event rates in pre-treated compared to treatment-naïve patients looking at drug-related AEs (64% versus 53%), serious AEs (68% versus 52%) and discontinuation due to an AE (16% versus 7%) (the median treatment duration was 139 weeks). However these differences for most AEs were modest and no new safety signals were identified. The most frequent AEs across both subgroups were nasopharyngitis, dizziness, and peripheral edema.

In terms of efficacy, significant improvements in exercise capacity (assessed as 6-minute walking distance) and WHO functional class were seen for both treatment-naïve and pretreated patients, although they were slightly greater in the treatment-naïve group. The frequency of clinical worsening events was similar in the two subgroups

MedicalResearch.com: What should readers take away from your report?

Response: In the PATENT-2 long-term extension study, riociguat continued to be well tolerated in both treatment-naïve and pretreated patients with PAH, achieving sustained improvement or stabilization in exercise capacity and WHO functional class in both subgroups over the 2 years of the study. These data support the use of long-term riociguat as monotherapy or in combination with ERAs or prostanoids in patients with PAH.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: The PATENT-1/2 study program has provided significant additional scientific evidence on sequential combination therapy, which has been considered in the recent ESC/ERS guidelines. However important questions on the optimal regimen for combination treatment of PAH remain to be answered: these include the impact of early/initial use of combination therapy versus sequential use, and selection of the optimal combination partner.

MedicalResearch.com: Is there anything else you would like to add?

Response: Riociguat is also approved for the treatment of inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension.
This study was supported by Bayer AG.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

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

Presented at the Pulmonary Vascular Research Institute Annual World Congress, Miami, Florida, USA, January 26 th−29th 2017

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Last Updated on February 17, 2017 by Marie Benz MD FAAD