[Effect of sulodexide on the walking, erectile and cognitive functions based on the findings of the ANDANTE study].

Abstract

Background: Lower extremity artery disease, or peripheral artery disease (PAD), is a common form of atherosclerosis associated with an increased risk of cardiovascular diseases and mortality. Patients with PAD are found to have atherosclerotic lesions of not only lower limb arteries but also those of other basins, as well as microcirculation disorders. This can manifest as decreased functions of blood-supplied organs. Sulodexide is a balanced mixture of highly purified naturally occurring glycosaminoglycans (GAGs): a fast-moving fraction of heparin and dermatan sulfate, beneficially influencing the endothelium of the arterial, venous and microcirculatory bed. The ANDANTE study is devoted to investigating the effect of sulodexide on health-related quality of life of patients with PAD. Besides quality of life, of interest are ANDANTE-studied parameters associated with physical and cognitive functions.

Objective: To describe secondary endpoints in the ANDANTE study: pain-free walking distance, self-assessment of walking quality, the ankle-brachial index, as well as cognitive and erectile functions.

Patients and methods: The study included a total of 229 both-gender, 37-to-90-year-old patients presenting with stage IIa-IIb PAD and taking oral sulodexide at a daily dose of 500-1000 LSU. After the screening visit, the participants underwent 4 follow-up visits, assessing health-related quality of life according to the SF-36 questionnaire, pain-free walking distance, the ankle-brachial index, walking ability according to the WELCH questionnaire, self-assessment of maintaining an erection (for men), and cognitive function according to the Hasegawa's Dementia Scale. The participants were stratified depending on the number of the given packs of sulodexide (<6 packs or ≥6 packs, with 60 capsules per pack) and the duration of treatment (≤3 or >3 months of treatment). The daily dose of sulodexide amounted to either 500 LSU or 1000 LSU depending on the physician's recommendation.

Results: The pain-free walking distance increased during 6 months of treatment from 327.3±258.2 to 565.7±490.9 m (p<0.01), with the increment amounting to 237.1±434.6 m, or 72.4%. The ankle-brachial index increased from 0.70 to 0.77 by 10.0% (p=0.01). The average score of self-assessment of walking ability by the WELCH scale significantly increased in the overall population from 21.2 to 36.4 by 71.0% (p<0.01). The average score of self-assessment of erection maintaining on the 3-point scale increased from 2.7 to 3.2 by 14.8% (p<0.01). The participants also demonstrated improved cognitive function by the Hasegawa's Dementia Scale from 23.8 to 26.7 points by 12.2% (p<0.01). All alterations were similar in the subgroups with different duration of treatment and different course dose of sulodexide.

Conclusion: The ANDANTE study showed efficacy of sulodexide in patients with PAD. Taking sulodexide at a daily dose of 500-1000 LSU resulted in a statistically significant increase in the painless walking distance by 72.4%, improvement of self-reported walking ability by 71.0%, self-assessment of maintaining an erection by 14.8%, and cognitive function by 12.2%. These results were consistent irrespective of both whether the patients were given <6 or ≥6 packs of sulodexide and whether they took it for ≤3 or >3 months.