Improvement of walking distance by defibrotide in patients with intermittent claudication - Results of a randomized, placebo-controlled study (the DICLIS study)

Defibrotide is an antithrombotic drug which enhances prostacyclin productio n and activates fibrinolytic system. The aim of this study was to investiga te the improvement of walking distance in patients with intermittent claudi cation treated with defibrotide. DICLIS was a double blind, placebo-controlled study which included patients with walking distance autonomy at a standardized treadmill test less than or equal to 350 greater than or equal to 100 meters. A total of 310 patient s were randomly allocated to placebo (n = 101), defibrotide 800 mg/day (n = 104) or defibrotide 1200 mg/day (n = 105). During a one year follow-up, the Absolute Walking Distance (AWD) was measur ed six times (0, 30, 60, 90, 180, 360 days). Similar improvement in walking distance was found in the three groups until the 90th day; thereafter placebo group showed no further increase, while A WD continued to increase in the defibrotide groups. Between the 180th and 3 60th day visits, AWD was significantly higher (P <0.01) in patients given d efibrotide than in patients given placebo. No difference in efficacy was ob served between the two dosages of defibrotide. No differences in side effec ts were observed among the three groups. The results of the present trial suggest that long-term administration of d efibrotide improves walking distance in patients with intermittent claudica tion.