DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, MULTICENTER CLINICAL-ASSESSMENT OF THE EFFICACY, TOLERABILITY AND DOSE-EFFECT RELATIONSHIP OF SULODEXIDE IN CHRONIC VENOUS INSUFFICIENCY

A multi-centre study was carried out in 476 patients with chronic veno us insufficiency to compare the efficacy, tolerability and dose-effect relationship of sulodexide given orally as either capsules or as a ne w, enteric-coated tablet formulation. Three comparable groups of patie nts each with chronic venous insufficiency of thrombotic or varicose a etiology received during 60 consecutive days either sulodexide 250 LRU (=25 mg) capsules twice daily, .50 mg sulodexide enteric-coated table ts twice daily or 100 mg sulodexide enteric-coated tablets once daily, according to a double-blind, double-dummy, rundomized design. Doppler and echoduplex examinations, supine and standing peripheral venous pr essure, specific symptoms and signs, peripheral haemodynamics and safe ty haematology and haematochemistry were monitored monthly. The result s showed that peripheral venous pressure improved to a clinically rele vant and statistically significant extent in all groups and symptoms a nd signs were rapidly and significantly relieved. These effects were d ose-related, as in both cases the recovery was faster and greater with the 100 mg per day dose however administered Both the thrombotic and varicose aetiologic sub-groups benefited from treatment to approximate ly the same extent. Mild to moderate gastro-intestinal adverse experie nces occurred in 48 patients evenly split between groups but spontaneo usly disappeared within 72 hours, none leading to treatment withdrawal . No clinically relevant modifications of peripheral haemodynamics or of safety haematology and haematochemistry was observed. The haemocoag ulation parameters failed to exhibit appreciable variations. While the known clinical usefulness of sulodexide 250 LRU (=25 mg) capsules twi ce daily was confirmed in this trial, the enteric-coated tablets, 50 m g twice daily or 100 mg once daily, were shown to have greater efficac y and similar tolerability to the standard formulation and dose.