This randomized, double-blind study investigated the effect of
ciprostene, a stable
epoprostenol (
prostacyclin) analog in patients with
peripheral vascular disease (PVD) characterized by ischemic
ulcers. A total of 211 patients (106
ciprostene, 105 placebo) received IV infusions of
ciprostene (120 ng/kg/min in 8-hour daily infusions for 7 days) or placebo. The two groups were comparable with regard to demographic data. Only 45% of the patients receiving
ciprostene and 55% of the placebo patients completed the trial. The groups were similar in frequency of
amputations,
vascular surgery, and development of new
ulcers. Among those who completed the trials an insignificantly higher percentage of patients receiving
ciprostene had all
ulcers heal completely. The reduction of
ulcer size by at least 50% was higher in the
ciprostene-treated group at month 4 (P = .005). Both
ciprostene and placebo reduced the severity of a patient's rest
pain. There was no difference in the ankle brachial index between the groups.
Ciprostene induced a higher incidence of
headache,
nausea, and
flushing during infusion when compared with the placebo group. The results confirmed inherent problems with studies in PVD, namely, scarcity of patients with ischemic
ulcers, inclusion of severely ill patients leading to a high dropout rate, and a high placebo effect. Good tolerance and safety of
ciprostene was documented in this patient population, and the therapeutic benefit was limited to partial reduction of
ulcer size. Selection of patients with less advanced disease and a longer infusion of
ciprostene may improve the clinical benefit of this agent.