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, p = 0.001), cardiovascular mortality (OR 0.44, 95% CI 0.22-0.89, p = 0.02), and MI (OR 0.70, 95% CI 0.51-0.96, p = 0.03), and nonsignificantly reduced odds of
stroke (OR 0.78, 95% CI 0.45-1.35, p = 0.38).
Sulodexide was associated with significantly reduced odds of VTE (OR 0.44, 95% CI 0.24-0.81, p = 0.008), including DVT (OR 0.41, 95% CI 0.26-0.65, p < 0.001), but not
pulmonary embolism (OR 0.92, 95% CI 0.40-2.15, p = 0.86).
Bleeding events were not significantly different in the two groups (OR 1.14, 95% CI 0.47-2.74, p = 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.