A study on the safety, efficacy, and efficiency of sulodexide compared with acenocoumarol in secondary prophylaxis in patients with deep venous thrombosis.

This study was carried out to study the safety and efficacy of a fixed dosage of sulodexide compared to adjusted dosages (INR) of acenocoumarol as secondary prophylaxis in patients with deep vein thrombosis (DVT) in lower limbs. An economic evaluation based on the criteria of use in normal clinical practice was also performed. One hundred and fifty patients of both sexes were included, all over 18 years of age and diagnosed with proximal DVT of the lower limbs by color echo-Doppler, and with clinical evolution of less than 1 month. The patients were initially treated with low-molecular-weight heparin (LMWH) and urokinase in accordance with the established protocol. They were then randomized to continue treatment with acenocoumarol and INR adjustments every 30 days, or with sulodexide. Treatment was extended for 3 months with monthly follow-up visits and a final visit at 3 months posttreatment. No differences between the groups were detected concerning demographic or basal characteristics in clinical evolution or adverse reactions. In the group treated with sulodexide, no major/minor hemorrhagic complications were detected. On the other hand, in the acenocoumarol group, 1 major hemorrhage and 9 minor hemorrhages were produced (13.3%), reaching statistical difference in relation to the sulodexide group (p = 0.014; CI from 95% of 4.7% to 19.4%). Regarding the economic impact, treatment costs with sulodexide are much less than those with acenocoumarol, the data confirmed by the sensitivity analyses performed. The results prove the efficacy, safety, and efficiency of sulodexide as a secondary prophylaxis in thromboembolic disease, avoiding hemorrhagic risks and the monitoring of patients, and providing significant savings to the health system.

RCT Entities:   Population Interventions Outcomes