Secondary endpoints in patients with PAH-CTD in PATENT-1
| Overall PAH-CTD | PAH-SSc | PAH-other defined CTD | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Riociguat 2.5 mg maximum | Placebo | Riociguat 2.5 mg maximum | Placebo | Riociguat 2.5 mg maximum | Placebo | |||||||||||||||||||
| Parameter, mean±SD | n | Baseline | n | Change at week 12 | n | Baseline | n | Change at week 12 | n | Baseline | n | Change at week 12 | n | Baseline | n | Change at week 12 | n | Baseline | n | Change at week 12 | n | Baseline | n | Change at week 12 |
| PVR (dyn·s·cm−5) | 71 | 647±350 | 65 | −181±208 | 25 | 627±342 | 20 | −37±229 | 43 | 552±231 | 40 | −132±140 | 16 | 615±391 | 12 | −79.4±199 | 25 | 801±469 | 22 | −276±283 | 6 | 558±186 | 6 | 106±251 |
| Cardiac index (L/min/m2) | 71 | 2.6±0.6 | 65 | 0.5±0.5 | 25 | 2.9±0.7 | 20 | −0.2±0.6 | 43 | 2.6±0.5 | 40 | 0.5±0.5 | 16 | 2.7±0.7 | 12 | 0.1±0.5 | 25 | 2.5±0.8 | 22 | 0.6±0.6 | 6 | 3.4±0.6 | 6 | −0.8±0.4 |
| mPAP (mm Hg) | 71 | 40.3±10.2 | 64 | −1.7±7.1 | 25 | 45.0±16.0 | 19 | −4.6±10.9 | 43 | 37.4±9.2 | 40 | −0.8±7.4 | 16 | 43.1±18.1 | 11 | −5.3±11.5 | 25 | 44.1±10.2 | 21 | −3.2±7.0 | 6 | 45.3±12.7 | 6 | −0.9±10.9 |
| RAP (mm Hg) | 71 | 7.2±4.4 | 65 | 0.7±7.8 | 25 | 6.0±3.8 | 20 | 0.7±5.1 | 43 | 7.2±4.6 | 40 | 0.3±4.8 | 16 | 6.8±3.7 | 12 | −0.2±4.2 | 25 | 7.4±4.3 | 22 | 1.2±11.9 | 6 | 4.5±3.6 | 6 | 2.3±7.3 |
| PCWP (mm Hg) | 71 | 8.8±3.1 | 65 | 2.4±3.9 | 25 | 8.9±3.3 | 20 | −0.2±4.3 | 43 | 9.1±3.1 | 40 | 2.3±3.7 | 16 | 9.3±3.3 | 12 | −1.1±4.1 | 25 | 8.6±2.9 | 22 | 2.4±4.5 | 6 | 7.3±3.3 | 6 | 1.5±5.1 |
| NT-proBNP (pg/mL) | 66 | 1026±1943 | 66 | 274±2576 | 17 | 819±836 | 17 | 54±778 | 39 | 718±1148 | 39 | 98±509 | 11 | 5276±14 196 | 10 | 142±904 | 24 | 1639±2800 | 24 | 589±4262 | 5 | 750±605 | 5 | −99±727 |
| EQ-5D | 70 | 0.69±0.20 | 70 | −0.01±0.24 | 24 | 0.66±0.33 | 24 | −0.02±0.40 | 43 | 0.65±0.21 | 43 | 0.03±0.24 | 15 | 0.69±0.34 | 15 | −0.07±0.45 | 24 | 0.77±0.18 | 24 | −0.08±0.25 | 6 | 0.74±0.09 | 6 | −0.03±0.25 |
| LPH | 68 | 41.6±19.9 | 68 | −3.32±19.2 | 24 | 42.3±23.7 | 24 | 2.01±26.3 | 41 | 41.5±21.2 | 41 | −3.2±18.6 | 15 | 37.8±23.7 | 15 | 5.1±29.6 | 24 | 40.1±17.8 | 24 | −3.0±19.8 | 6 | 47.8±26.7 | 6 | −5.2±15.4 |
Missing values, where the patient withdrew or died, were imputed at week 12 for NT-proBNP, EQ-5D and LPH, according to the last observed value.
CTD, connective tissue disease; EQ-5D, EuroQol five dimensions questionnaire; LPH, living with pulmonary hypertension questionnaire; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; mPAP, mean pulmonary artery pressure; PAH, pulmonary arterial hypertension; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular resistance; RAP, right atrial pressure; SSc, systemic sclerosis.