[A meta-analysis of efficacy and safety of sulodexide in the prevention and treatment of venous thromboembolism].

Abstract

Objective: To evaluate the efficacy and safety of sulodexide in preventing venous thromboembolism (VTE) in high-risk populations and reducing recurrence in established VTE patients. Methods: A literature search was conducted in databases including China National Knowledge Infrastructure, Wanfang Data, VIP Chinese Periodical Database, China Biology Medicine disc, PubMed, Embase, the Cochrane Library, and Web of Science to retrieve relevant literature on sulodexide in the treatment of VTE, with the retrieval time frame set from the establishment of the databases to April 2024. According to the inclusion and exclusion criteria, two researchers independently screened the literature and extracted the data. The Cochrane risk of bias tool or the Newcastle-Ottawa Scale was used to evaluate the quality of the included studies. Meta-analysis was performed using Revman5.4.1 software, with the RR value as the effect measure. The trial group comprised high-risk individuals or VTE patients treated with sulodexide, while the control group consisted of patients treated with other traditional anticoagulants or placebos. The outcome measures included the incidence and recurrence rate of VTE, the incidence of post-thrombotic syndrome (PTS), and the risk of bleeding, among others. Results: A total of 11 articles involving 11 studies and 3 364 patients were included according to the inclusion and exclusion criteria. For high-risk populations of VTE, prophylactic use of sulodexide was more effective than the control group in reducing the incidence of VTE in high-risk individuals [2.2% (3/138) vs 10.9% (15/138), RR=0.25, 95%CI: 0.09-0.72, P=0.010]. For VTE patients, sulodexide was more effective than control group in reducing the recurrence rate of VTE [5.6% (56/996) vs 9.7% (198/2 043), RR=0.59, 95%CI: 0.44-0.80, P<0.001]. There was no statistically significant difference in the incidence of PTS between patients treated with sulodexide and those treated with other traditional anticoagulants [14.0% (36/257) vs 16.6% (149/897), RR=0.86, 95%CI: 0.61-1.20, P=0.370]. Moreover, the incidence of bleeding events was lower in patients treated with sulodexide compared to those treated with other traditional anticoagulants [0.8% (2/251) vs 6.1% (40/656), RR=0.11, 95%CI: 0.03-0.37, P<0.001]. Conclusion: Sulodexide exhibits favorable efficacy and safety for VTE prevention in high-risk populations and recurrence reduction in VTE patients.