Journal article

Publication year: 2015

Pages: 1303-1313

Journal: European Respiratory Journal

Volume number: 45

Issue number: 5

ISSN: 0903-1936

eISSN: 1399-3003

Open access status: Bronze

DOI Link: https://doi.org/10.1183/09031936.00090614

Publisher: European Respiratory Society

Abstract: 

Riociguat is a soluble, guanylate cyclase stimulator, approved for pulmonary arterial hypertension. In the 12-week PATENT-1 study, riociguat was well tolerated and improved several clinically relevant end-points in patients with pulmonary arterial hypertension who were treatment naive or had been pretreated with endothelin-receptor antagonists or prostanoids. The PATENT-2 open-label extension evaluated the long-term safety and efficacy of riociguat.

Eligible patients from the PATENT-1 study received riociguat individually adjusted up to a maximum dose of 2.5 mg three times daily. The primary objective was to assess the safety and tolerability of riociguat; exploratory efficacy assessments included 6-min walking distance and World Health Organization (WHO) functional class.

Overall, 396 patients entered the PATENT-2 study and 324 (82%) were ongoing at this interim analysis (March 2013). The safety profile of riociguat in PATENT-2 was similar to that observed in PATENT-1, with cases of haemoptysis and pulmonary haemorrhage also being observed in PATENT-2. Improvements in the patients', 6-min walking distance and WHO functional class observed in PATENT-1 persisted for up to 1 year in PATENT-2. In the observed population at the 1-year time point, mean +/- SD 6-min walking distance had changed by 51 +/- 74 m and WHO functional class had improved in 33%, stabilised in 61% and worsened in 6% of the patients versus the PATENT-1 baseline.

Long-term riociguat was well tolerated in patients with pulmonary arterial hypertension, and led to sustained improvements in exercise capacity and functional capacity for up to 1 year.

Harvard Citation style: Rubin, L., Galie, N., Grimminger, F., Gruenig, E., Humbert, M., Jing, Z., et al. (2015) Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2), European Respiratory Journal, 45(5), pp. 1303-1313. https://doi.org/10.1183/09031936.00090614

APA Citation style: Rubin, L., Galie, N., Grimminger, F., Gruenig, E., Humbert, M., Jing, Z., Keogh, A., Langleben, D., Fritsch, A., Menezes, F., Davie, N., & Ghofrani, H. (2015). Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2). European Respiratory Journal. 45(5), 1303-1313. https://doi.org/10.1183/09031936.00090614