[Clinical experience in patients with chronic peripheral obliterating arteriopathy: defibrotide versus definite...

In a controlled study of 100 patients, mean age 65 years old, suffering from chronic peripheral obliterative arterial disease, Leriche's stage II, were randomised in two groups treated respectively with defibrotide (400 mg bid) or heparan-sulfate (40 mg bid) by the oral route for a period of 6 months. At basal and after 30, 90 and 180 treatment days, patients were assessed for pain, paresthesias, rigidity and or tiredness in the leg, Winsor index (WI) relative and absolute walking distance (RWD, AWD), and time of recovery from pain. In order to evaluate microcirculation the following parameters were tested: resting flow (RF), standing flow (SF), veno-arteriolar reflex (VAR) and a capillaroscopy study was conducted. All patients showed an improvement in the clinical and instrumental parameters but more pronounced in the defibrotide group; the difference between the beginning and the end of the therapy was significantly better for defibrotide (p < 0.01). The tolerability observed was good, no side-effects were reported during the study.