Placebo | Riociguat 2.5 mg-maximum group | ||||||
---|---|---|---|---|---|---|---|
No. of patients | Baseline | Change | No. of patients | Baseline | Change | LS mean difference (95% CI) | |
PATENT-1 | |||||||
Primary endpoint | |||||||
6MWD (m) | 24 | 387±50 | –16±73 | 43 | 382±51 | 31±83 | 46 (5 to 87) |
Secondary endpoints | |||||||
PVR (dynes/s/cm5) | 21 | 1154±511 | 83±480 | 41 | 1232±542 | –379±333 | –436 (–623 to –249) |
NT-proBNP (pg/mL) | 21 | 1328±1914 | 127±796 | 43 | 1152±1162 | –571±866 | –761 (–1085 to –436) |
WHO FC, n (%) | 24 | I: 2 (8%) II: 13 (54%) III: 9 (38%) IV: 0 | Improved: 6 (25%) Stabilised: 12 (50%) Worsened: 6 (25%) | 43 | I: 1 (2%) II: 29 (67%) III: 13 (30%) IV: 0 | Improved: 7 (16%) Stabilised: 35 (81%) Worsened: 1 (2%) | – |
Borg dyspnoea score* | 24 | 3.2±1.7 | 0.2±2.1 | 43 | 2.9±1.5 | –0.4±1.5 | – |
EQ-5D score | 23 | 0.7±0.1 | –0.06±0.3 | 43 | 0.7±0.3 | 0.06±0.2 | 0.1 (–0.01 to 0.2) |
LPH score | 24 | 50±24 | 1.5±16 | 43 | 48±25 | –9±18 | –11 (–19 to –3) |
CHEST-1 | |||||||
Primary endpoint | |||||||
6MWD (m) | 11 | 364±85 | –48±122 | 21 | 375±57 | 51±55 | 102 (39 to 165) |
Secondary endpoints | |||||||
PVR (dynes/s/cm5) | 10 | 1037±584 | 95±358 | 18 | 1075±354 | –249±262 | –338 (–577 to –99) |
NT-proBNP (pg/mL) | 11 | 2022±2492 | 510±839 | 21 | 1601±1151 | –538±1107 | –1042 (–1841 to –242) |
WHO FC, n (%) | 11 | I: 0 II: 6 (55%) III: 5 (45%) IV: 0 | Improved: 1 (9%) Stabilised: 9 (82%) Worsened: 1 (9%) | 21 | I: 2 (10%) II: 11 (52%) III: 8 (38%) IV: 0 | Improved: 8 (38%) Stabilised: 12 (57%) Worsened: 1 (5%) | – |
Borg dyspnoea score* | 11 | 4.5±2.5 | –0.5±3.6 | 21 | 3.5±2.0 | –1.2±2.3 | – |
EQ-5D score | 11 | 0.6±0.1 | –0.1±0.4 | 21 | 0.5±0.3 | 0.2±0.2 | 0.3 (0.1 to 0.5) |
LPH score | 11 | 72±17 | –5±21 | 21 | 59±22 | –19±21 | –21 (–35 to –6) |
Mean±SD values are presented unless otherwise stated.
*Borg dyspnoea scale ranges from 0 to 10, with 0 representing no dyspnoea and 10 representing maximal dyspnoea.
6MWD, 6 min walking distance; EQ-5D, EuroQol Group 5-Dimension Self-Report Questionnaire (scores range from –0.6 to 1.0, with higher scores indicating a better quality of life); LPH, Living with Pulmonary Hypertension questionnaire (an adaptation of the Minnesota Living with Heart Failure Questionnaire; scores range from 0 to 105, with higher scores indicating worse quality of life); LS, least-squares; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; PVR, pulmonary vascular resistance; WHO FC, WHO functional class (ranges from I to IV, with higher numbers indicating greater functional limitations).