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Treatment of Diabetic Microangiopathy and Edema with HR (Paroven, Venoruton; 0-(β-hydroxyethyl)-rutosides): A Prospective, Placebo-Controlled, Randomized Study

Journal of cardiovascular pharmacology and therapeutics, 2002, Vol.7 (1_suppl), p.S11-S15

ISSN: 1074-2484 ;EISSN: 1940-4034 ;DOI: 10.1177/107424840200700104 ;PMID: 12011967

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  • Title:
    Treatment of Diabetic Microangiopathy and Edema with HR (Paroven, Venoruton; 0-(β-hydroxyethyl)-rutosides): A Prospective, Placebo-Controlled, Randomized Study
  • Author: Incandela, L. ; Cesarone, M. R. ; DeSanctis, M. T. ; Belcaro, G. ; Dugall, M. ; Acerbi, G.
  • Subjects: Adult ; Diabetic Angiopathies - complications ; Diabetic Angiopathies - drug therapy ; Diabetic Neuropathies - complications ; Diabetic Neuropathies - drug therapy ; Edema - drug therapy ; Edema - etiology ; Female ; Humans ; Hydroxyethylrutoside - analogs & derivatives ; Hydroxyethylrutoside - pharmacology ; Hypertension - drug therapy ; Hypertension - etiology ; Laser-Doppler Flowmetry ; Male ; Microcirculation ; Middle Aged ; Placebos ; Skin Ulcer ; Treatment Outcome ; Vasoconstrictor Agents - pharmacology
  • Is Part Of: Journal of cardiovascular pharmacology and therapeutics, 2002, Vol.7 (1_suppl), p.S11-S15
  • Description: This study was planned to demonstrate in a prospective, placebo-controlled, randomized study, whether HR (Paroven, Venoruton; 0-(P-hydroxyethyl)-rutosides), is effective in improving the microcirculation in subjects with diabetic microangiopathy and neuropathy. Patients with severe diabetic microangiopathy, neuropathy and edema, patients with microangiopathy, without neuropathy, and 20 healthy subjects were included. Microangiopathy was defined by laser Doppler flowmetry and capillary filtration (rate of ankle swelling (RAS)). Inclusion criteria were: increase in resting flux (RF) and RAS, a decrease in venoarteriolar response (VAR), and alterations in flux increase with temperature. The 2 groups of patients and the control group were randomized in a treatment sub-group which received HR (1 g, twice daily for 6 months); those in the placebo group received similar treatment.Results: Groups were comparable; there were no drop-outs. There were no differences in the treatment and placebo groups at inclusion. Treatment was well tolerated; no adverse effects were reported. No variations were observed in healthy subjects at 6 months. In both groups of patients, significant decreases (P < 0.05) in RF and RAS were observed in the active treatment groups. The decrease in RAS was associated with a decrease in edema (P < 0.05) in both treatment groups. The decrease in RF and the increase in VAR were associated with a proportional decrease in RAS (P < 0.05). In patients without neuropathy, the variations in RF, VAR, and RAS were larger (P < 0.05) at 6 months. The variations in healthy subjects were limited and not significant.Conclusion: The decrease in capillary filtration and edema with HR is associated with symptomatic improvement. The action on edema is beneficial for the evolution of neuropathy. The effects of HR on flux, RAS, and edema are important in early stages of microangiopathy to avoid progression to clinical stages.
  • Publisher: Thousand Oaks, CA: SAGE Publications
  • Language: English
  • Identifier: ISSN: 1074-2484
    EISSN: 1940-4034
    DOI: 10.1177/107424840200700104
    PMID: 12011967
  • Source: Journals@Ovid Open Access Journal Collection Rolling
    MEDLINE
    Alma/SFX Local Collection
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