Effects of iloprost (a prostacyclin analogue) on the endothelial dysfunction and foot ulcers in diabetic patients with peripheral arterial disease

Abstract

Objectives: To asses the efficiency of iloprost (an analogue of prostacyclin) infusion on endothelial functions and amputation rate in diabetic foot ulcers with complicated macroangiopathy. Material and Methods: Sixty (36 men / 24 women) type 2 diabetic patients (61.8 ± 9.7 years, mean ±SD) with diabetic foot ulcer and peripheral arterial occlusive disease, stage III or more by Wagner classification, and 15 (9 male/ 6 female) healthy controls (60.7 ± 9.1 years, mean ±SD) were enrolled in the study. Thirty patients (group I) had iloprost infusion (0.5-2 ng/kg/min for 6 h) for 10 consecutive days. Endothelial functions were determined by brachial arterial flow mediated dilation (FMD) method at stage 0 (basal), 10th and 30th days. Group II patients (n=30) were treated in the same manner as group I except iloprost treatment constituting a patient control group. Results: Group I patients showed a significant improvement in the endothelial functions at 10th day, and 30th day (p=0.002) in respect to group II . There were no differences between group I and group II regarding the hospitalization period and amputation rates. Iloprost was well tolerated. Three patients had adverse reactions such as maculo-papular skin eruptions, itching, hypotension and dyspnea due to iloprost infusion; one completed the treatment and 2 had to discontinue the iloprost infusion. Conclusion: Ten-day iloprost infusion therapy to patients with diabetic foot ulcers seems to be efficient in the improvement of endothelial function, but, despite our positive clinical observation, this improvement does not affect the outcome of the amputation rates at 30 days follow up period.