Brigham and Women's Hospital, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts.
Semin Thromb Hemost. 2020 Nov;46(8):908-918. doi: 10.1055/s-0040-1716874. Epub 2020 Oct 21.
Thrombotic cardiovascular disease (myocardial infarction [MI], stroke, and venous thromboembolism [VTE]) remains a major cause of death and disability. Sulodexide is an oral glycosaminoglycan containing heparan sulfate and dermatan sulfate. We conducted a systematic review and meta-analysis to determine the cardiovascular efficacy, and safety of sulodexide versus control in randomized controlled trials (RCTs). We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs reporting cardiovascular outcomes in patients receiving sulodexide versus control (placebo or no treatment). Outcomes included all-cause mortality, cardiovascular mortality, MI, stroke, deep vein thrombosis (DVT), pulmonary embolism, and bleeding. We used inverse variance random-effects models with odds ratio (OR) as the effect measure. After screening 360 records, 6 RCTs including 7,596 patients (median follow-up duration: 11.6 months) were included. Patients were enrolled for history of MI, VTE, peripheral arterial disease, or cardiovascular risk factors plus nephropathy. Use of sulodexide compared with control was associated with reduced odds of all-cause mortality (OR 0.67, 95% confidence interval [CI] 0.52-0.85, = 0.001), cardiovascular mortality (OR 0.44, 95% CI 0.22-0.89, = 0.02), and MI (OR 0.70, 95% CI 0.51-0.96, = 0.03), and nonsignificantly reduced odds of stroke (OR 0.78, 95% CI 0.45-1.35, = 0.38). Sulodexide was associated with significantly reduced odds of VTE (OR 0.44, 95% CI 0.24-0.81, = 0.008), including DVT (OR 0.41, 95% CI 0.26-0.65, < 0.001), but not pulmonary embolism (OR 0.92, 95% CI 0.40-2.15, = 0.86). Bleeding events were not significantly different in the two groups (OR 1.14, 95% CI 0.47-2.74, = 0.48). In six RCTs across a variety of clinical indications, use of sulodexide compared with placebo or no treatment was associated with reduced odds of all-cause mortality, cardiovascular mortality, MI, and DVT, without a significant increase in bleeding. Additional studies with this agent are warranted.
血栓性心血管疾病（心肌梗死[MI]、中风和静脉血栓栓塞[VTE]）仍然是死亡和残疾的主要原因。舒洛地特是一种口服糖胺聚糖，含有肝素硫酸盐和硫酸皮肤素。我们进行了系统评价和荟萃分析，以确定舒洛地特与对照（安慰剂或无治疗）在随机对照试验（RCT）中的心血管疗效和安全性。我们检索了 MEDLINE、Embase 和 Cochrane 对照试验中心注册库，以查找报告接受舒洛地特与对照（安慰剂或无治疗）治疗的患者心血管结局的 RCT。结局包括全因死亡率、心血管死亡率、MI、中风、深静脉血栓形成（DVT）、肺栓塞和出血。我们使用了具有比值比（OR）作为效应量的逆方差随机效应模型。在筛选了 360 条记录后，纳入了 6 项 RCT，共 7596 名患者（中位随访时间：11.6 个月）。患者因 MI、VTE、外周动脉疾病或心血管危险因素加肾病而被纳入。与对照组相比，使用舒洛地特与全因死亡率降低相关（OR 0.67，95%置信区间[CI]0.52-0.85， = 0.001）、心血管死亡率（OR 0.44，95% CI 0.22-0.89， = 0.02）和 MI（OR 0.70，95% CI 0.51-0.96， = 0.03），且中风的几率降低无统计学意义（OR 0.78，95% CI 0.45-1.35， = 0.38）。舒洛地特与 VTE（OR 0.44，95% CI 0.24-0.81， = 0.008）的几率降低显著相关，包括 DVT（OR 0.41，95% CI 0.26-0.65， < 0.001），但不包括肺栓塞（OR 0.92，95% CI 0.40-2.15， = 0.86）。两组的出血事件无显著差异（OR 1.14，95% CI 0.47-2.74， = 0.48）。在 6 项涉及各种临床适应证的 RCT 中，与安慰剂或无治疗相比，使用舒洛地特与全因死亡率、心血管死亡率、MI 和 DVT 几率降低相关，且出血增加无统计学意义。需要进一步研究这种药物。
