Table 1 Baseline characteristics of PAH‐CTD subgroup study population.
| Characteristic | Treatment group | |||||
|---|---|---|---|---|---|---|
| STRIDE‐1 | Extension† | |||||
| Placebo (n = 9) | SITAX 100/300 mg pooled data (n = 33) | SITAX 100/300 mg pooled data (n = 41) | ||||
| Age (years), mean (SD) (range) | 43 (18) (18 to 69) | 51 (11) (26 to 70) | 50 (13) (18 to 70) | |||
| Gender | ||||||
| Female, n. (%) | 8 (89) | 31 (94) | 38 (93) | |||
| Race/ethnicity, n (%) | ||||||
| White | 4 (44) | 19 (58) | 23 (56) | |||
| Hispanic | 3 (33) | 4 (12) | 6 (15) | |||
| African | 0 | 6 (18) | 6 (15) | |||
| Asian | 1 (11) | 3 (9) | 4 (10) | |||
| Other | 1 (11) | 1 (3) | 2 (5) | |||
| Type of CTD,* n (%) with | ||||||
| Scleroderma | 2 (22) | 17 (51) | 19 (46) | |||
| SLE | 5 (56) | 11 (33) | 15 (37) | |||
| MCTD or overlap syndrome | 2 (22) | 5 (15) | 7 (17) | |||
| NYHA functional class, n (%) in | ||||||
| Class II | 3 (33) | 10 (30) | 12 (29) | |||
| Class III | 6 (67) | 23 (70) | 29 (71) | |||
| Prior or concomitant treatment, n (%) | ||||||
| Warfarin | 7 (78) | 23 (70) | 30 (71) | |||
| Diuretics | 4 (44) | 23 (70) | 27 (64) | |||
| Calcium channel blockers | 5 (56) | 25 (76) | 30 (71) | |||
| Digoxin | 2 (22) | 6 (18) | 8 (19) | |||
| Supplemental oxygen | 2 (22) | 7 (21) | 9 (21) | |||
| Exercise and haemodynamic parameters | ||||||
| 6MWD, m | 414 (59) | 340 (108) | 355 (105) | |||
| VO2max, % of predicted | 44 (15) | 43 (11) | 43 (11) | |||
| Mean pulmonary arterial pressure, mmHg | 44 (8) | 46 (11) | 46 (11) | |||
| Right atrial pressure, mmHg | 7 (6) | 8 (5) | 8.3 (4) | |||
| Cardiac index, l/min/m2 | 2.4 (0.8) | 2.6 (0.8) | 2.5 (0.8) | |||
| Pulmonary vascular resistance, dynes/sec/cm−5 | 722 (255) | 735 (365) | 773 (74) | |||
6MWD, 6‐minute walk distance; MCTD, connective tissue disease; NYHA, New York Heart Association; SLE, systemic lupus erythematosus; VO2max, peak oxygen consumption during cardiopulmonary exercise testing.
*By individual investigator judgment.
†All patients on active sitaxsentan treatment (100/300 mg).