Five-year treatment of chronic venous insufficiency with O-(β-hydroxyethyl)-rutosides: Safety aspects

Abstract

Chronic venous insufficiency (CVI), and related signs and symptoms of venous and diabetic microangiopathy, can be effectively treated with O-(β-hydroxyethyl)-rutosides (HR). The aim of the present independent registry study was to evaluate HR in a long-term (five-year) period of administration that examined the tolerability and safety of HR. Patients with severe CVI and venous microangiopathy were included in the registry. Subjects who completed five years of treatment were considered in the analysis. Blood parameters, liver and renal function tests, microalbuminuria (in diabetic patients) and cholesterol levels were evaluated to assess the effects of HR treatment. Four groups were studied - group A (98 patients) received oral HR (1500 mg per day), group B (87 diabetic patients with CVI) was treated with 2 g of HR per day, group C (90 controls, including 42 diabetic patients) had no pharmacological treatment and group D (113 patients, including 48 diabetic patients) used elastic stockings. No significant negative changes in blood parameters were recorded at two and five years. Decreases in microalbuminuria and total cholesterol, and an increase in high-density lipoprotein cholesterol were observed in HR-treated patients, particularly in diabetic patients. Minimal (nonsignificant) variations were observed in the groups that did not use HR. In conclusion, HR treatment is safe, and some positive effects from HR on cholesterol levels and microalbuminuria (in diabetic patients) that were previously observed may suggest potential new clinical applications.

Rutin as a Potent Antioxidant: Implications for Neurodegenerative Disorders

“…The benchmark for authenticating rutin's neuroprotective properties is clinical trials in humans. A few clinical trials have been conducted to examine the effect of a compound from the rutin family, O-( β -hydroxyethyl)-rutosides (HRs) in venous disease patients with diabetes treated for a prolonged period of time [ 211 ]. HRs is obtained by substituting rutin hydroxyl groups with O- β -hydroxyethyl groups.…”

“…HRs is obtained by substituting rutin hydroxyl groups with O- β -hydroxyethyl groups. Human clinical trials with rutin (in the form of HRs) have shown that it is safe and well tolerated [ 211 ]. The lack of clinical trials exploring the efficacy of rutin in NDs is of concern.…”

Choosing conservative therapy in acute hemorrhoids

“…Согласно национальным и международным клиническим руководствам, применение комбинированных флеботонических препаратов позволяет повысить эффективность терапии и снизить риски рецидива заболевания [17][18][19][20][21][22]. Значимость флеботропных препаратов в лечении хронической венозной недостаточности достаточно изучена, что позволяет их широко использовать в симптоматической терапии, в то время как эффективность флеботонических препаратов в лечение геморроя до сих пор обсуждается, несмотря на имеющиеся результаты проведенных исследований [23][24][25][26][27][28][29]. Флеботропные препараты повышают тонус венозной стенки, благоприятно влияют на микроциркуляцию, улучшают венозный кровоток и лимфатический дренаж за счет увеличения частоты и амплитуды перистальтики лимфатических сосудов, купируют воспалительные реакции за счет подавления адгезии лейкоцитов к эндотелию, препятствуя их миграции в перивазальное пространство и блокируя выброс цитокинов и протеолитических энзимов [20,30,31].…”

Scientific Opinion on the substantiation of a health claim related to a combination of diosmin, troxerutin and hesperidin and maintenance of normal venous‐capillary permeability pursuant to Article 13(5) of Regulation (EC) No 1924/2006

“…In seven human studies submitted, the effect of different flavonoids (diosmin and beta-hydroxyethylrutosides, beta-hydroxyethyl-rutosides, diosmin and hesperidin, and micronised purified flavanoid fraction (MPFF) consisting of diosmin and hesperidin), on symptoms of chronic venous disease was evaluated (Jantet, 2000;Belcaro et al, 2002;Danielsson et al, 2002;Jantet et al, 2002;Cesarone et al, 2006;Belcaro et al, 2008;Stuard et al, 2008). Other studies were related to pharmacokinetic EFSA Journal 2014;12(1):3511 aspects (Kienzler et al, 2002;Kanaze et al, 2007) and the methods of detection of flavonoids in the human body (Spanakis et al, 2008) and did not address the effects of the food which is the subject of the claim.…”