Clinical evaluation of short-term defibrotide treatment of patients with atherosclerosis obliterans of the lower limbs.

Ten patients with atherosclerosis obliterans of the lower limbs (Fontaine stage IV) were studied under basal conditions during and after short-term administration of defibrotide (800 mg/day intravenously from day 1 to 10 and then 400 mg/day intramuscularly from day 11 to 30). The clinical effectiveness of defibrotide was evaluated not only clinically (subjective and objective symptomatology) but also by Doppler velocimetry (Windsor's Index (WI] and primary antiplasmin activity. Seven patients (70%) showed improvement in subjective and objective symptomatology. There were increases in WI at the end of intravenous treatment in 6 patients (60%). In the remaining 40%, WI did not change from basal values. All patients showed normalization of primary antiplasmin activity versus basal values (55.62%, 17.75 SD) at the end of both intravenous and intramuscular treatment (101.37%, 15.71 SD and 102.5%, 13.86 SD, respectively). Therefore, we think that defibrotide may be useful for therapy of atherosclerosis obliterans of the lower limbs.