Table 3 Details of included combination therapy RCTs*
Reference | Barst 2011 (PHIRST-1) | Simonneau 2008 (PACES) | McLaughlin 2006 (STEP) | Humbert 2004 (BREATHE-2) | ||||
|---|---|---|---|---|---|---|---|---|
Baseline therapy | ERA | Pr (iv epo) | ERA | None | ||||
Add-on therapy | PDE5i | Placebo | PDE5i | Placebo | Pr (inh ilp) | Placebo | ERA | ERA+ Pr (iv epo) |
Treatment dose | 40 mg tadalafil once daily | 3x20mg sildenafil daily, increased to 40 and 80 at 4 week intervals | 5 μg inhaled iloprost | 62.5 mg bosentan twice daily, increased to 125 mg twice daily after 4 weeks. Intravenous epoprostenol started at 2 ng/kg/min and increased up to 14 ± 2 ng/kg/min after 16 weeks. | ||||
Patients at end of trial | 42 | 45 | 133 | 123 | 34 | 33 | 19 | 10 |
Duration | 16 weeks | 16 weeks | 12 weeks | 16 weeks | ||||
Change 6MWD | 40.2 (8.5) | 18.8 (9.2) | 29.8 (5.3) | 1 (5.3) | 30 (10.3) | 4 (10.6) | 72 (11.47) | 46 (19.61) |
Baseline 6MWD | 360.9 (11.6) | 348.5 (12.7) | 348.9 (6.2) | 341 (6.7) | 331 (73) | 340 (64) | 323.04§ | 323.62§ |
Age | 50 | 51.7 | 47.8 | 47.5 | 49 | 51 | 45 | 47 |
Sex (% male) | 0.21 | 0.22 | 0.18 | 0.23 | 0.21 | 0.21 | 0.23 | 0.45 |
STATUS | 2.5 | 2.7 | 2.8 | 2.8 | 3.0 | 3.0 | 3.23 | 3.27 |
PVR | 863.3 | 863.3 | 856.8 | 754.9 | 815 | 783 | 1511 | 1426 |