Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2021, 165(2):157-161 | DOI: 10.5507/bp.2019.061

The impact of riociguat on clinical parameters and quality of life in patients with chronic thromboembolic pulmonary hypertension - results of a retrospective clinical registry

Pavel Jansa^a, David Ambroz^a, Jan Kuchar^b, Vladimir Dytrych^a, Jaroslav Lindner^c, Ales Linhart^a

^a 2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic

^b Department of Cardiology, Tabor Hospital, Inc., Czech Republic

^c 2nd Department of Surgery - Department of Cardiovascular Surgery, First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic

Aims: The primary objective of the registry was to assess the impact of riociguat on clinical parameters and quality of life in patients with chronic thromboembolic pulmonary hypertension (CTEPH) that was inoperable or persistent/recurrent after pulmonary endarterectomy (PEA). In contrast to randomized pivotal trials, this non-interventional registry evaluated the effectiveness and safety of riociguat in a real-world setting.

Methods: Retrospective data were collected from patients' charts as recorded in routine clinical practice from the initiation of riociguat therapy up to approximately 5 months and 1 year after this initiation.

Results: In total, 51 patients from a single site were enrolled. After 5 months (mean duration) of riociguat treatment, the following improvements from baseline were observed: change of distance in the 6-minute walking distance (6MWD) (P=0.066); change of score from the quality of life questionnaire (EQ5D-5L) (P=0.020), and overall self-assessment of health status (P=0.001). New York Heart Association (NYHA) class improved in 24.3% of patients. After 11.2 months (mean duration) of riociguat treatment, the following improvements from baseline were observed: change of distance in the 6MWD test (P=0.006), and overall self-assessment of health status (P=0.009). NYHA class improved in 46.4% of patients. Riociguat was well tolerated. In total, 4 patients reported side effects, with hospitalization required in one case and 2 patients who had to discontinue the treatment. Annual survival rate was 89.1%.

Conclusion: Riociguat improves functional NYHA class, distance in the 6MWD test and quality of life in a real-world patient population.

Keywords: riociguat, chronic thromboembolic pulmonary hypertension, clinical parameters, quality of life, real-world population

Received: November 18, 2019; Revised: December 13, 2019; Accepted: December 13, 2019; Prepublished online: January 20, 2020; Published: June 10, 2021  Show citation