TREATMENT OF LOWER-LIMB ISCHEMIA DUE TO ATHEROSCLEROSIS IN DIABETIC AND NONDIABETIC PATIENTS WITH ILOPROST, A STABLE ANALOG OF PROSTACYCLIN - RESULTS OF A FRENCH MULTICENTER TRIAL

A double-blind placebo controlled study was conducted in patients with advanced peripheral arterial occlusive disease (PAOD) to determine the efficacy and tolerability of iloprost, a stable analogue of prostacyclin (PGI2). 85 men and 43 women (74 of whom were diabetic) with resting pain and/or ischaemic lesions of the lower limbs were enrolled in the study. Iloprost was given daily over 6 hours for 21 days by continuous intravenous infusion. Treatment efficacy was assessed on days 21, 28, 60 and 120. Resting pain was improved with treatment: disappearance of pain at day 28 occurred in 50% of patients in the iloprost group and in 19% in the placebo group (p < 0.05). Analgesic consumption was significantly lower in the iloprost group at day 60. No difference was noted for trophic lesions, mean systolic ankle pressure and transcutaneous oxygen pressure (TCpO2). Clinical tolerability was significantly better in the placebo group. Side effects (headache, flushing, nausea and vomiting) were more frequent in the iloprost group, but the risk: benefit ratio was better with iloprost than with placebo. These results suggest that iloprost may be an alternative to amputation in patients with critical ischaemia who are unsuitable for reconstructive surgery.