Sulodexide for treating venous leg ulcers

Wu, Bin; Lu, Jing; Yang, Ming; Xu, Ting

doi:10.1002/14651858.cd010694.pub2

Cited by 35 publications

(32 citation statements)

References 40 publications

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“…We included all comparative and non-comparative trials assessing the efficacy of sulodexide in patients with CVD at any disease stage. We excluded studies that did not meet the above criteria as well as studies that exclusively monitored the size and/or frequency of venous ulcer healing, already examined in other meta-analyses [46,47]. We imposed no limitation on language, journal, diagnostic criterion or CEAP class (for the studies carried out after the relevant consensus) or use of compression measures.…”

Section: Criteria For Considering Studies For This Reviewmentioning

confidence: 99%

“…We excluded 41 studies that were originally considered as potentially eligible. The reasons for exclusion were: no clinical data reported (n = 13) [12,13,29,[39][40][41][73][74][75][76][77][78][79], indication other than CVD with data on CVD symptoms not available/not extractable (n = 13) [80][81][82][83][84][85][86][87][88][89][90][91][92], no extractable data on symptoms (n = 9) [36,[93][94][95][96][97][98][99][100][101], preliminary partial publication (n = 3) [102][103][104], data reported but not stratified by treatment (n = 1) [105], review (n = 1) [47] or duplicate (n = 1) [98].…”

Section: Excluded Studiesmentioning

confidence: 99%

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Sulodexide for the Symptoms and Signs of Chronic Venous Disease: A Systematic Review and Meta-analysis

Bignamini

Matuška²

2020

Adv Ther

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Introduction: Chronic venous disease (CVD) is a common condition associated with valvular dysfunction, venous hypertension and endothelial inflammation. Sulodexide facilitates the healing of venous ulcers and is frequently used in patients with CVD without ulcer. This review assessed the efficacy and safety of sulodexide for treatment of signs and symptoms of lower extremity CVD. Methods: We searched MEDLINE, EMBASE, CINAHL and AMED as well as the Cochrane Central Register of Controlled Trials and the World Health Organisation (WHO) International Clinical Trials Registry Platform Search Portal. We also manually searched potentially relevant journals, conference proceedings and journal supplements. Any study monitoring any effect of sulodexide in patients with CVD at any stage of the disease, classified or non-classified, was considered. Treatment effects were estimated using standardised mean differences (SMDs), mean differences (MDs) and risk ratios (RRs), as appropriate. We calculated 95% confidence intervals (CIs) and heterogeneity (Q, tau and I 2 ). Results: The search found 64 studies, but only 23 provided data on 7153 participants (mean age 55 years; 68% female). The 13 studies providing extractable quantitative information included 1901 participants (mean age 55.2 years; 65% female). Sulodexide decreased the intensity of pain, cramps, heaviness, oedema and total symptom score and reduced inflammatory mediators in patients with CVD. The risk of adverse events (AEs) was not different between sulodexide and placebo or heparan sulphate (RR 1.31, 95% CI 0.74-2.32; I 2 = 0%; 270 participants). The overall risk of AEs with sulodexide was low: 3% (95% CI 1-4%) estimated from 3656 participants. Conclusion: Sulodexide was found to have a beneficial venoactive effect on the major signs and symptoms of CVD such as pain, cramps, heaviness and oedema without increasing the risk of AEs. It is also likely to exert a systemic effect on the course of CVD by interfering with inflammatory chemokines. Key Summary PointsThe majority of validated approaches for the management of chronic venous disease (CVD) are relatively invasive and may be limited by patient acceptance; compression is instead usually associated with poor compliance.This systematic review assessed the efficacy and safety of sulodexide for treatment of signs and symptoms of lower extremity CVD by reviewing the literature and conducting a meta-analysis.Sulodexide had a beneficial venoactive effect on the major signs and symptoms of CVD, such as pain, cramps, heaviness and oedema, without increasing the risk of adverse events. It is also likely to exert a systemic effect on the course of CVD by interfering with inflammatory chemokines.

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Section: Criteria For Considering Studies For This Reviewmentioning

confidence: 99%

Section: Excluded Studiesmentioning

confidence: 99%

Sulodexide for the Symptoms and Signs of Chronic Venous Disease: A Systematic Review and Meta-analysis

Bignamini

Matuška²

2020

Adv Ther

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“…Given the evidence of high rates of false positives and negatives, diagnostic tests must be chosen carefully to minimise methodological error margins that currently exist. Targeting procoagulant factors may hold promise in the treatment of CVD and further studies should extend to previously trialled targeted therapies, including topical treatment with tissue plasminogen activator (Zeegelaar et al, 1997) and oral regimes of sulodexide, a purified glycosaminoglycan with fibrinolytic properties (Wu et al, 2016). Thrombophilia in CVD is not a new conceptthe earliest study included in this review was performed over 20 years agoand appears to be related to non-thrombotic CVD development.…”

Section: Discussionmentioning

confidence: 99%

Thrombophilia in non‐thrombotic chronic venous disease of the lower limb – a systematic review

et al. 2018

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Summary Chronic venous disease (CVD) represents a significant healthcare burden. Thrombophilia is proposed as a risk factor, particularly for post‐thrombotic CVD. A systematic review was performed to determine the relationship between thrombophilia and non‐thrombotic CVD. MEDLINE® and Embase® databases were searched from 1946 up to March 2018. Case‐control studies, cohort studies or randomised clinical trials reporting on thrombophilias in non‐thrombotic lower limb CVD in adult patients were included. Non‐English and post‐thrombotic syndrome studies were excluded. Study selection and data extraction were performed by two reviewers. Fifteen studies were included, reporting on 916 cases and 1261 controls. Studies largely focused on venous ulceration and investigated multiple haemostatic factors. An association between thrombophilia and non‐thrombotic CVD was identified, with greater prevalence and factor concentration alteration reported in patients compared to controls. Concomitant thrombophilia presence was associated with earlier CVD onset. Relationship strength varied, with commoner aetiologies showing clearer correlation than rarer ones. Thrombophilia is associated with non‐thrombotic CVD but the mechanism is unclear and causation cannot be determined. Future research should focus on prospective studies with larger populations and identify adjunct therapies targeting thrombophilia.

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“…Also, adding systemic granulocyte-colony stimulating factors, which help in the release and function improvement of neutrophil endothelial progenitor cells (usually lacking in diabetic patients), or hyperbaric oxygen, which improves the oxygen supply to wounds, showed a reduction in the need for more extended hospitalization stays and the need for amputations in people with chronic wounds [92,93]. Many other systemic drugs (e.g., aspirin, flavonoids, thromboxane alpha-2 agonists, sulodexide) improve the wound environment [94][95][96][97]. However, caution in the use of this latter treatment is needed to evaluate if the benefits overcome their associated risks: antimicrobial resistance, allergic reactions, drug toxicities (cardiac, hepatic, renal, and hematopoietic), and drug interactions [98].…”

Section: Non-phage-based Wound Treatmentsmentioning

confidence: 99%

Bacteriophages for Chronic Wound Treatment: From Traditional to Novel Delivery Systems

Pinto

Cerqueira

Bañobre-Lópes

et al. 2020

Viruses

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The treatment and management of chronic wounds presents a massive financial burden for global health care systems, with significant and disturbing consequences for the patients affected. These wounds remain challenging to treat, reduce the patients' life quality, and are responsible for a high percentage of limb amputations and many premature deaths. The presence of bacterial biofilms hampers chronic wound therapy due to the high tolerance of biofilm cells to many firstand second-line antibiotics. Due to the appearance of antibiotic-resistant and multidrug-resistant pathogens in these types of wounds, the research for alternative and complementary therapeutic approaches has increased. Bacteriophage (phage) therapy, discovered in the early 1900s, has been revived in the last few decades due to its antibacterial efficacy against antibiotic-resistant clinical isolates. Its use in the treatment of non-healing wounds has shown promising outcomes. In this review, we focus on the societal problems of chronic wounds, describe both the history and ongoing clinical trials of chronic wound-related treatments, and also outline experiments carried out for efficacy evaluation with different phage-host systems using in vitro, ex vivo, and in vivo animal models. We also describe the modern and most recent delivery systems developed for the incorporation of phages for species-targeted antibacterial control while protecting them upon exposure to harsh conditions, increasing the shelf life and facilitating storage of phage-based products. In this review, we also highlight the advances in phage therapy regulation.

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Sulodexide for treating venous leg ulcers

Cited by 35 publications

References 40 publications

Sulodexide for the Symptoms and Signs of Chronic Venous Disease: A Systematic Review and Meta-analysis

Sulodexide for the Symptoms and Signs of Chronic Venous Disease: A Systematic Review and Meta-analysis

Thrombophilia in non‐thrombotic chronic venous disease of the lower limb – a systematic review

Bacteriophages for Chronic Wound Treatment: From Traditional to Novel Delivery Systems

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