Table 1.
Characteristic | Full analysis set (n = 300) |
Switched patients (n = 84)a |
Treatment-naïve patients (n = 216) |
---|---|---|---|
Sex, n (%) | |||
Female | 185 (62) | 55 (65) | 130 (60) |
Male | 115 (38) | 29 (35) | 86 (40) |
Age (mean ± SD), years | 63.9 ± 12.5 | 65.5 ± 11.6 | 63.3 ± 12.7 |
Type of CTEPH, n (%) | |||
Inoperable | 216 (72) | 64 (76) | 152 (70) |
Persistent/recurrent | 84 (28) | 20 (24) | 64 (30) |
WHO FC, n (%) | |||
I | 5 (2) | 0 | 5 (2) |
II | 112 (37) | 31 (37) | 81 (38) |
III | 175 (58) | 51 (61) | 124 (57) |
IV | 8 (3) | 2 (2) | 6 (3) |
6MWD (mean ± SD), m | 374 ± 117b | 389 ± 87c | 369 ± 125d |
6MWD 6-min walking distance, CTEPH chronic thromboembolic pulmonary hypertension, ERA endothelin receptor antagonist, PDE5 phosphodiesterase type 5, SD standard deviation, WHO FC World Health Organization functional class
aPatients who previously received an ERA, prostacyclin, and/or PDE5 inhibitor, and who stopped this treatment before starting riociguat
b n = 213; last observed value prior to start of study treatment
c n = 52
d n = 161