Sulodexide in Patients with Chronic Venous Disease of the Lower Limbs: Clinical Efficacy and Impact on Quality of Life

Abstract

IntroductionChronic venous disease (CVD) of the lower limbs is a common problem. It is more prevalent in women than in men and has a significant impact on patients’ quality of life (QoL) and on the healthcare system. The aim of this study was to evaluate the efficacy of sulodexide in adult patients with CVD of the lower limbs and its effect on patients’ QoL.MethodsPatients with CVD were treated with sulodexide [250 LSU (lipasemic units) twice daily] for 3 months in a setting of real-life clinical practice. The endpoints of this observational non-comparative, open-label prospective study were the clinical efficacy of sulodexide (evaluated by scoring objective and subjective symptoms with a Likert-type scale) and the impact of sulodexide therapy on patients’ QoL [assessed using the chronic venous insufficiency quality of life questionnaire (CIVIQ)].ResultsThe study included 450 patients (mean age 46.9 ± 10.5 years, range 17–78 years). A greater percentage of patients were female (65.4%). Three months of treatment with sulodexide significantly improved all objective and subjective symptoms (p < 0.0001). Overall, patients reported a significant improvement in all QoL scores (p < 0.0001). Adverse events were spontaneously reported by two patients (one case of epigastric pain and one of gastric pain with vomiting).ConclusionOral sulodexide significantly improves both objective and subjective symptoms, as well as functional and psychological aspects of QoL in patients with CVD.FundingNo funding or sponsorship was received for this study. Sponsorship for article processing charges and open access fees was provided by Alfa Wassermann.

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

“…We identified 23 studies that could provide information on the effect of sulodexide in the management of CVD [42,44,45,48,[54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71][72], with exclusion of the studies exclusively reporting the course of venous ulcers. Whenever possible, data were retrieved from the original tables; where data were reported as graphs only, numeric data were reconstructed by analysing the graphs at high magnification with a high definition software and applying standard algorithms in R. Studies were published in English, Italian, Spanish, Polish, Russian and Chinese but no limitation was imposed on the language.…”

“…Symptoms of CVD for which at least two studies provided interpretable data were: total symptoms score [63,68], pain [56,59,61,64,65,67,68,70], cramps [45,56,59,63,64,67,70], paraesthesia [45,56,59,60,64,67] and heaviness [45,60,61,67,70]. All these variables were monitored by means of scales rating the intensity 0-3 except for one study where pain was measured with the VAS [68].…”

“…Pain was reported in 8 studies on a total of 927 patients [56,59,61,64,65,67,68,70] monitored for 2 (N = 46) [56,61], 3 (N = 866) [59,64,67,68,70] or 6 (N = 15) months [65]. Six studies used the conventional 0-3 scoring system [56,59,61,64,65,67], one used a 0-5 scale [70] and one used the visual analogue scale (VAS) [68]. We used the standardised mean difference to estimate the effect, with the random effects model (Fig.…”

“…Seven studies reported the intensity of cramps (frequently reported as ''nocturnal'' cramps) measured with the usual scale 0-3 [45,56,59,63,64,67], except one that used the 0-5 scale [70]. Overall, 1427 patients were monitored, of whom 480 were treated for 2 months [56,63] and the rest for 3 months.…”

Use of sulodexide for the treatment of disorders of peripheral microcirculation in patients with systemic sclerosis

“…In peritoneal dialysis patients, limitation of transperitoneal protein loss after chronic administration of sulodexide to the dialysis fluid was observed [15]. This medicine is used to treat vascular dementia, venous thrombosis, venous insufficiency and leg ulcers [16] as well as lowering blood pressure [17].…”