A double blind placebo controlled trial of intravenous prostacyclin (PGI2) in 108 patients with ischaemic peripheral vascular disease.
108 patients with ischemic peripheral vascular disease were randomly allocated to receive infusion of either PGI2 (6 ng/kg/min over 8 hours daily for 5 consecutive days) or placebo in a double-blind manner. All patients had Stage II disease (Fontaine classification). One month after infusion the absolute and relative walking times were significantly (p less than 0.05) longer in the PGI2- than in the placebo-treated group. Patients were further classified as treatment responders or non-responders on the basis of increase of absolute and relative walking times. After one month 44% (24 out of 54) of the PGI2- and 15% (8 out of 54) of the placebo-treated patients were positive treatment-responders (p less than 0.01).
Virgolini
I
I
2nd Department of Internal Medicine, Policlinic, Vienna, Austria.
Fitscha
P
P
Linet
O I
OI
O'Grady
J
J
Sinzinger
H
H
D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D011464:Epoprostenol / Q000008:administration & dosage / Q000627:therapeutic use*; D005080:Exercise Test; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000503:physiopathology; D007511:Ischemia / Q000188:drug therapy* / Q000503:physiopathology; D010919:Placebos
D010919:Placebos; D011464:Epoprostenol