Sulodexide for the Prevention of Recurrent Thromboembolism
What is the effect of sulodexide for preventing recurrent venous thromboembolism?
In this multicenter double-blind study, 615 patients with first-ever unprovoked venous thromboembolism who had completed 3-12 months of oral anticoagulant treatment were randomly assigned to sulodexide, 500 lipasemic units twice daily, or placebo for 2 years, in addition to elastic stockings. The primary efficacy outcome was recurrence of venous thromboembolism. Major or clinically relevant bleeding was the primary safety outcome.
Venous thromboembolism recurred in 15 of the 307 patients who received sulodexide and in 30 of the 308 patients who received placebo (hazard ratio, 0.49; 95% confidence interval [CI], 0.27-0.92; p = 0.025). The analysis assigning lost to follow-up to failure, yielded a risk ratio among treated versus controls of 0.54 (95% CI, 0.35-0.85; p = 0.009). No major bleeding episodes occurred; two patients in each treatment group had a clinically relevant bleeding episode. Adverse events were similar in the two groups.
The authors concluded that sulodexide given after discontinuation of anticoagulant treatment reduced the risk of recurrence in patients with unprovoked venous thromboembolism, with no apparent increase of bleeding risk.
This study reports that treatment with oral sulodexide for 2 years, along with compression therapy, decreased the incidence of recurrences of thromboembolic events without detectable risks. Additional prospective research is needed to validate these findings and determine whether a similar effect can be obtained after treatment of the index event with non–vitamin K antagonist oral anticoagulants. It remains to be determined whether prevention of recurrence could equally be performed with sulodexide, antiplatelets, or extended anticoagulation or whether specific subgroups are more or less likely to benefit from sulodexide or other anticoagulation treatments.
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