EFFICACY, TOLERABILITY, AND DOSE-EFFECT RELATIONSHIP OF ORAL SULODEXIDE IN OBSTRUCTIVE PERIPHERAL ARTERIAL DISORDERS

Four groups of 62 patients each with obstructive peripheral arterial d isorders were assigned to receive placebo, 25-mg sulodexide capsules t wice a day, 50-mg enteric-coated tablets twice a day, or 1 00-mg enter ic-coated tablets once a day for 90 days in a double-blind, double-dum my, randomized investigation. Doppler analysis, Winsor Index, treadmil l test, peripheral hemodynamics, and hematologic and hematochemical an alyses were performed monthly. The Winsor Index significantly improved in all treated groups vs placebo, with faster and greater improvement in the 50-mg twice-daily and 1 00-mg once-daily groups than in the 25 -mg twice-daily group. Treadmill test results also improved significan tly in sulodexide patients, probably because of improved local perfusi on, again to a greater extent in the same dosage groups. No appreciabl e differences were observed between 50-mg twice-daily and 100-mg once- daily groups. Twenty-six patients, evenly divided among groups, compla ined of mild or moderate adverse reactions, all but two gastrointestin al, that disappeared within 72 hours (in two patients after treatment withdrawal). Clinically relevant laboratory changes, including coagula tion values, were not observed. Enteric-coated sulodexide tablets, 50 mg twice a day or 100 mg once a day, appear to have greater efficacy t han and similar tolerability to the 25-mg capsules given twice daily. The latter regimen has more efficacy than, and similar tolerability to , placebo.