Defibrotide and peripheral obliterative arterial disease: preliminary data.

In a pilot study, defibrotide was administered to 22 patients with arterial occlusive disease of the lower limbs (mean age 59 years; range 48-71 years), of whom 12 were Fontaine 2nd stage and 10 Fontaine 3rd stage. In the first group, treatment enabled significant improvement in the walking distance (580 +/- 95 vs 220 +/- 65 m; M +/- SD; p less than 0.001), even 15 days after discontinuation of therapy (445 +/- 110 m; p less than 0.05). In 3rd stage patients, treatment caused reasonable reduction of pain, with elimination of resting pain in 4 patients. Both groups underwent no modification of Doppler velocimetry and Winsor index, while photoplethysmography in 8 patients at 2nd- and in 3 patients at 3rd-stage showed improvement at the end of treatment. There were no modifications of hepatic, renal, hemopoietic and hemocoagulative functions. Beta-thromboglobulin showed a statistically significant reduction (62 +/- 10 vs 116 +/- 18 ng/ml; M +/- SEM; p less than 0.001), from 2 weeks after the first dose until 15 days after discontinuation of therapy. Defibrotide proved particularly efficacious in Fontaine 2nd-stage patients, showing its suitability for treating the stages of occlusive atherosclerotic disease at which collateral circulation can still be activated.