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
IPAH / CTD / CHD
CTEPH / HIV / PPHTN

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