Use of the prostacyclin analogue iloprost in the treatment of patients with critical limb ischaemia.

Five large, placebo-controlled, randomised prospective multicentre trials have been completed in several European countries, including a total of 728 patients with critical limb ischaemia (CLI). 593 had ulceration or gangrene and it is these which will be analysed in detail. Only patients with CLI who were unsuitable for further reopening procedures were entered and approximately a third of the patients had already had attempts at surgical revascularisation or interventional radiology. The maximum tolerated dose up to 2 ng/kg/min was determined during the first three days and then continued as a six-hourly intravenous infusion every day for two to four weeks, depending on the study. Pooled results showed a significant overall 21% increase in ulcer healing rate due to iloprost (p less than 0.001) compared with placebo. The improvement was greater in the three studies when treatment was continued for four weeks. The very hard end point of a major amputation or death during a 3 to 6 month follow up was available in three of the studies. Analysis of these together demonstrated a significantly lower incidence of major amputations after iloprost treatment (p less than 0.05). Thus the existing weight of evidence from a large number of patients suggests that a course of intravenous iloprost is useful in the management of patients with CLI and trophic skin changes, who are unsuitable for reconstructive surgery or catheter procedures.

RCT Entities:   Population Interventions Outcomes