Other Prostanoids
Prostanoids: Clinical trials of prostacyclin analogues
Ranodmized controlled clinical trials of prostacyclin analogues
| Trial | Olschewski et al. 2002 | Simmoneau et al. 2002 | Galié et al. 2002 | Barst et al. 2003 | Lanleben et al. 2002 |
| Endothelin receptor antag. | Iloprost | Treprostinil | Beraprost | Beraprost | Trebogrel |
| Route | Inhaled | Subcutaneous | Oral | Oral | Oral |
| Patients (n) | 203 | 469 | 130 | 116 | Halted (71) |
|
Etiology of PH |
54 / 17 / 0 28 / 0 / 0 |
[58 / 7 / 21 0 / 0 / 0 |
48 / 7 / 21 0 / 7 / 16 |
74 / 10 / 16 0 / 0 / 0 |
|
| NYHA II / II / IV (%) | 0 / 59 / 41 | 11 / 82 / 7 | 49 / 51 / 0 | 53 / 47 / 0 | |
| Duration | 3 | 3 | 3 | 12 | |
| Primary endpoint |
6-MW +NYHA |
6-MW | 6-MW | ||
| Improvement in 6-MW (m) compared to controls | +36 | +16 | +25 | +23 (NS) | NS study stopped |
| Improvement in other enpoints |
NYHA, QOL Clinical Events | Hemodyn Clinical events, QOL |
|||
| Side effects (n) | Flush, jaw, pain | Infusion site pain (200) GI hemorrage (3) |
Headache(44) Diarrhea (17) Leg pain (14) |
Diarrhea Leg pain |
Leg pain in 48% of verum |
Modified according to Galié et al. 2004; GI = gastrointestinal; Hemodyn = hemodynamics; 6-MW = 6-minute walking distance; NS = not significant; QOL = Quality of life