Reference | Badesch 2002 | Rubin 2002 (BREATHE-1) | Barst 2006 (STRIDE-2) | Barst 1996 | Galie 2005 (SUPER-1) | |||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline therapy | None | None | None | Conventional | None | |||||
Add-on therapy | ERA | Placebo | ERA | Placebo | ERA | Placebo | Pr (iv ep) | Conventional | PDE5i | Placebo |
Treatment dose | 62.5 mg bosentan twice daily, increased to 125 mg twice daily after 4 weeks. | 62.5 mg bosentan twice daily, increased to either 125 mg or 250 mg twice daily after 4 weeks. | 62.5 mg bosentan twice daily, increased to 125 mg twice daily after 4 weeks. | mean dose of intravenous epoprostenol 9.2 ng/kg/min | 80 mg sildenafil orally 3 times daily | |||||
Patients at end of trial | 21 | 11 | 144 | 69 | 60 | 62 | 41 | 40 | 71 | 70 |
Duration | 12 weeks | 16 weeks | 18 weeks | 12 weeks | 12 weeks | |||||
Change 6MWD | 70 (23.4) | −6 (50.5) | 36 (6.5) | −8 (9.5) | 23 (9.3) | −6.5 (9.2) | 32 (24.8) | −15 (33) | 50 (9) | 2 (7) |
Baseline 6MWD | 360 (18.8) | 355 (24.7) | 330 (6.2) | 344 (9.1) | 337 (10.1) | 321 (10.8) | 316 (18) | 272 (23.0) | 339 (9.4) | 344 (9.4) |
Age | 52.2 | 47.4 | 48.7 | 47.2 | 49 | 53 | 40 | 40 | 48 | 49 |
Sex (% male) | 0.19 | 0 | 0.21 | 0.22 | 0.22 | 0.24 | 0.24 | 0.3 | 0.21 | 0.19 |
STATUS | 3 | 3 | 3.097222 | 3.057971 | 2.65 | 2.693548 | 3.243902 | 3.275 | 2.619718 | 2.557143 |
PVR | 896 | 942 | 1014 | 880 | 880 | 880 | 1280 | 1280 | 918 | 1051 |