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Prostanoids
Clinical trials of prostacyclin analogues

Randomized controlled clinical trials of prostacyclin analogues

Trial	Olschewski et  al. 2002	Simonneau  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 / III / 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	-	-
Sideeffects (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

References

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