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.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
Brock FE, Abri O, Baitsch G, Bechara G, Beck K, et al. Iloprost in der Behandlung ischämischer Gewebsläsionen bei Diabetikern. Schweizerische Medizinische Wochenschrift 120: 1477–1482, 1990
Cronenwett JL. The use of prostaglandins PGE1 and PGI2 in peripheral arterial ischaemia. Journal of Vascular Surgery 2: 370–374, 1986
Darius H, Hossemann V, Schrör K. Antiplatelet effects of intravenous iloprost in patients with peripheral arterial obliterative disease. Klinische Wochenschrift 64: 545–551, 1986
Diehm C, Abri O, Baitsch G, Bechara G, Beck K, et al. Iloprost, a stable prostacyclin derivative, in the treatment of stage IV arterial disease: a placebo controlled multicentre trial. Deutsche Medizinische Wochenschrift 114: 783–788, 1989
Fiessinger JN, Schäfer M. Trial of iloprost for critical limb ischaemia of thromboangiitis obliterans. Lancet 1: 555–557, 1990
Fonseca V, Dandona P. Treatment of ischaemic ulceration or rest pain with intravenous iloprost: a double-blind placebo controlled study. British Diabetic Association, Glasgow: 22–24 Mar 1990
Kaukinen S, Pessi T, Ylitalo P, Krais T, Vapaatalo H, et al. Clinical study on ZK 36374: a new stable prostacyclin analog for treatment of peripheral vascular disease, pp. 23–30, Raven Press, New York, 1985
Moncada S, Higgs EA, Vane JR. Human arterial and venous tissues generate prostacyclin (prostaglandin X), a potent inhibitor of platelet aggregation. Lancet 1: 18–21, 1977
Norgren L, Alwmark A, Angqvist KA, Hedberg B, Bergqvist D, et al. A stable prostacyclin analogue (Iloprost) in the treatment of ischaemic ulcers of the lower limb. A Scandinavian-Polish placebo controlled, randomised multicenter study. European Journal of Vascular Surgery 4: 463–467, 1990
Oberender H, Krais TH, Schäfer M, Belcher G. Clinical benefits of iloprost, a stable prostacyclin (PGI2) analog in severe peripheral arterial disease (PAD). Advances in Prostaglandins, Thromboxane and Leukotriene Research 19: 311–316, 1989
Schillinger E, Krais TH, Lehmann M, Stock G. Iloprost. In Scriabine (Ed.) New cardiovascular drugs, pp. 209–231, Raven Press, New York, 1986
French Iloprost Study Group
A list of participants and their centres is given at the end of the article.
About this article
Cite this article
Guilmot, J., Diot, E. Treatment of Lower Limb Ischaemia Due to Atherosclerosis in Diabetic and Nondiabetic Patients with Iloprost, a Stable Analogue of Prostacyclin. Drug Invest. 3, 351–359 (1991). https://doi.org/10.1007/BF03259752
- Drug Invest
- Peripheral Arterial Occlusive Disease
- Analgesic Consumption