[The effect of sulodexide on the quality of life of patients with intermittent claudication: results of a multicenter observational study of ANDANTE].

Abstract

Relevance: Arterial disease of the lower extremities is a common form of atherosclerosis associated with an increased risk of cardiovascular disease and mortality. Arterial disease of the lower extremities tends to progress from asymptomatic forms to intermittent claudication and critical ischemia. Sulodexide therapy in patients with PH allows for increased pain-free walking distance. At the same time, the scientific literature has not fully documented how long-term sulodexide therapy affects the quality of life of patients with arterial disease of the lower extremities. The aim of the study was to evaluate the effect of sulodexide on the quality of life of patients with arterial disease of the lower extremities.

Material and methods: The multicenter prospective observational study of ANDANTE included patients with PH stage IIa-IIb according to the classification of A.V. Pokrovsky receiving sulodexide therapy. During the 6-month follow-up, 4 visits were conducted, during which the quality of life was analyzed based on a subjective assessment of physical and mental health using the SF-36 questionnaire. Pain-free walking distance, ankle-shoulder index, self-assessment of erection retention, WELCH walking ability scale scores, and Hasegawa dementia scale scores were also evaluated for men. In this article, we have considered only the dynamics of patients' quality of life in terms of physical and mental health on the SF-36 scale as the primary endpoint of the study. In the future, data on other criteria for the treatment of patients will be presented.

Results: The study included 229 patients aged 37 to 90 years (on average, 65.0±9.9 years). Men prevailed among the patients - 159 (69.4%) patients. There were 118 (51.5%) smokers and 111 (48.5%) non-smokers. The average duration of the disease from the moment of diagnosis of arterial disease of the lower extremities to inclusion in the study was 6.0±6.3 years. In addition to OCD, 72.5% of patients were diagnosed with hypertension, 28.4% with cerebrovascular disease, 26.6% with coronary heart disease, 25.3% with diabetes mellitus, and 19.7% with erectile dysfunction. At the time of inclusion in the study, 61.6% of patients were taking antiplatelet agents, 10.9% were taking direct oral anticoagulants, and 46.3% of patients were taking lipid-lowering therapy. At the time of inclusion in the study, 147 (64.2%) patients followed the recommendations on physical activity. Revascularization before inclusion in the study was performed in 19.2%, and 80.8% were treated conservatively. The study did not record any adverse events during sulodexide therapy. Compliance with therapy was high and averaged 4.6 points on a 5-point scale. The indicators of the physical aspect of the quality of life on the SF-36 scale significantly increased (p<0.01) after 6 months of treatment with sulodexide from 35.7±8.3 points on the first visit, to 44.6±7.2 points on the fourth. At the same time, the indicator increased by 8.9 (24.9%) points. The mental aspect of the quality of life during treatment also significantly improved from 45.4±9.9 to 51.6±6.7 points, an increase of 6.2 (13.6%) points.

Conclusion: ANDANTE's study showed an improvement in subjective physical by 24.9% and mental by 13.6% aspects of quality of life on the background of sulodexide therapy in patients with ZANK.