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5-Year Control and Treatment of Edema and Increased Capillary Filtration in Venous Hypertension and Diabetic Microangiopathy Using O-(β-Hydroxyethyl)-Rutosides: A Prospective Comparative Clinical Registry

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy, Cardres{at}abol.it

Maria Rosaria Cesarone, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Andrea Ledda, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Marisa Cacchio, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Irma Ruffini, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Andrea Ricci, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Edmondo Ippolito, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Andrea Di Renzo

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Mark Dugall

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Marcello Corsi, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Anna Rita Marino Santarelli, MD

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

Maria Giovanna Grossi

Department of Biomedical Sciences, Chieti-Pescara University, and the San Valentino Vascular Screening Project, Italy

This independent prospective controlled trial evaluates the efficacy of O-(β-hydroxyethyl)-rutosides (HR) during 5 years of administration against signs and symptoms and further degeneration of microcirculatory disturbances. The protective effect of HR in preventing end-point complications such as venous ulceration is evaluated. This study is based on evaluation of edema and the capillary filtration rate (CFR) in association with a clinical score scale. Patients having a severe degree of chronic venous insufficiency (CVI) and venous microangiopathy and completing at least 5 years of treatment are included. The following 4 groups are considered: group A (patients with CVI but without diabetes mellitus, receiving 1500 mg/d of HR), group B (patients with CVI and diabetes mellitus, receiving 2 g/d of HR), group C (control subjects receiving no pharmacologic or compression treatment), and group D (patients using elastic compression stockings only). All patients received the "best" available treatment. No adverse effects or intolerance is noted, with good compliance (>85%). In group A, there is a statistically significant decrease in the CFR during 5 years of follow-up. In group B, the decrease in the CFR is greater than that in group A. Reductions in edema, swelling, and the CFR during 5 years are notable, and values approach normal levels. During 5 years, HR is effective in treating venous edema and hypertension and in preventing deterioration of the distal venous system. The prevention of ulcerations with HR is another important observation. The effects of HR seem to be partially dose related, and tolerability and compliance are good.

Key Words: venous disease • varicose veins • ulcerations • HR • O-(β-hydroxyethyl)-rutosides • elastic compression • edema • veins • venous microangiopathy • diabeticnicroangiopathy

Angiology, Vol. 59, No. 1 suppl, 14S-20S (2008)
DOI: 10.1177/0003319707312683


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