Table 4.
Author/study | Year | Treatment | Design | Endpoint | Effect | No. FC II | Treat | FC II analysis |
---|---|---|---|---|---|---|---|---|
Galiè SUPER-142 | 2005 | sildenafil | DB R P | 6MWD | +42 m p < 0.001 | 108 of 278 | 75* | +40 m |
Galiè43 | 2005 | ambrisentan | DB R P | 6MWD | +36 m p < 0.0001 | 23 of 64 | 17 | +58 m |
Galie EARLY36 | 2008 | bosentan | DB R P | PVR | −197 p < 0.0001 | 185 of 185 | 93 | n/a |
6MWD | +19 m ns | n/a | ||||||
Galiè ARIES44 | 2008 | ambrisentan | DB R P | 6MWD | +43 m | 165 of 383 | 113* | 36–55 m |
Simonneau UT1545 | 2002 | trepostinil | DB R P | 6MWD | +10 m | 53 of 470 | 25 | No |
Galiè ALPHABET46 | 2002 | beraprost | DB R P | 6MWD | +15 m | 64 of 130 | 31 | No |
Barst47 | 2003 | beraprost | DB R P | VO2 max | p < 0.002 | 61 of 116 | 33 | No |
Barst STRIDE-148 | 2003 | sitaxentan | DB R P | VO2 max | +1.1 | 59 of 178 | 37 | No |
Sastry49 | 2004 | sildenafil | DB X P | Treadmill test | +211s p < 0.0001 | 18 of 22 | 18 | No |
Barst STRIDE-232 | 2006 | sitaxentan | DB R P | 6MWD | +28 m p < 0.05 | 92 of 185 | 47 | No |
bosentan | 6MWD | +29 m p < 0.05 | 22 | No | ||||
Simonneau PACES50 | 2008 | sildenafil | DB R P | 6MWD | +29 m | 71 of 267 | 35* | No |
Notes: Treat column refers to the number of patients enrolled in each trial in FC I or II and assigned to treatment arm.
includes FC I patients.
Abbreviations: DB, double blind; R, randomized; P, placebo-controlled; X, crossover; 6MWD, six-minute walk distance; PVR, pulmonary vascular resistance; FC, functional class.