Table 2.
Baseline characteristics in the controlled main studies (means ± standard deviations or frequencies, respectively, in the pooled IMP and comparator groups)
| Parameter | ULA | NES | LEV | TEZld | TEZhd | CIN | SER |
|---|---|---|---|---|---|---|---|
| n | 106a | 246 | 203 | 84b | 285c | 148d | 71e |
| Age (years) | 60 ± 12 | –f | 59 ± 11 | –f | 61 ± 13 | 62 ± 11 | 69 ± 12 |
| Male (%) | 76 | –f | 87 | –f | 79 | 85 | 75 |
| HR (/min) | 76 ± 12 | – | 82 ± 16 | –f | – | 80 ± 14 | 76 ± 17 |
| PAWP (mmHg) | 25 ± 6 | 28 ± 7 | 25 ± 8 | 26 ± 6 | 25 ± 7 | 25 ± 5 | 26 ± 6 |
| Cardiac index (L/min/m2) | 1.90 ± 0.35 | 2.18 ± 0.73 | 1.93 ± 0.40 | 2.08 ± 0.49 | 1.93 ± 0.36 | 2.16 ± 0.60 | 2.30 ± 0.65 |
| RAP (mmHg) | 10 ± 5 | −15 ± 7 | −10 ± 7 | 15 ± 7 | – | 12 ± 5 | 13 ± 6 |
| SBP (mmHg) | 126 ± 19 | 121 ± 22 | 114 ± 18 | –f | – | 123 ± 17 | 131 ± 16 |
| SVR (dyn·s/cm5) | 1863 ± 512 | 1443 ± 611 | 1959 ± 565 | 1778 ± 678 | – | 1605 ± 524 | 1623 ± 538 |
–, not shown; CIN, cinaciguat; HR, hazard ratio; IMP, investigational medical product; LEV, levosimendan; NES, nesiritide; PAWP, pulmonary arterial wedge pressure; RAP, right atrial pressure; SBP, systolic blood pressure; SER, serelaxin; SVR, systemic vascular resistance; TEZhd, tezosentan high dose; TEZld, tezosentan low dose; ULA, ularitide.
a
HR, PAWP, cardiac index, RAP, SBP (n = 104), and SVR (n = 100).
b
RAP (n = 83).
c
PAWP (n = 256).
d
PAWP, cardiac index, RAP, and SVR (n = 139).
e
HR, PAWP, cardiac index, RAP, and SVR (n = 63).
f
Values not available for the subgroup of catheterized patients.