Table 6.
Timepoint | Full analysis set | Switched patientsa | Treatment-naïve patients | |||
---|---|---|---|---|---|---|
n | Change from baseline (mean ± SD), m |
n | Change from baseline (mean ± SD), m |
n | Change from baseline (mean ± SD), m |
|
Dose-adjustment phase | ||||||
Week 2 | 75 | +20 ± 42 | 22 | +8 ± 48 | 53 | +25 ± 38 |
Week 4 | 77 | +34 ± 39 | 19 | +36 ± 31 | 58 | +34 ± 42 |
Week 6 | 72 | +41 ± 49 | 20 | +30 ± 39 | 52 | +45 ± 53 |
Week 8 | 93 | +30 ± 70 | 21 | +26 ± 47 | 72 | +31 ± 76 |
Maintenance phase | ||||||
Week 12 | 130 | +33 ± 42 | 32 | +28 ± 39 | 98 | +34 ± 43 |
Week 24 | 105 | +30 ± 63 | 20 | +32 ± 45 | 85 | +29 ± 67 |
Week 36 | 93 | +32 ± 59 | 24 | +37 ± 44 | 69 | +31 ± 64 |
Week 48 | 62 | +42 ± 60 | 13 | +36 ± 68 | 49 | +43 ± 59 |
6MWD 6-min walking distance, ERA endothelin receptor antagonist, PDE5 phosphodiesterase type 5, SD standard deviation
aPatients who previously received an ERA, prostacyclin, and/or PDE5 inhibitor, and who stopped this treatment before starting riociguat