HYDROXYETHYLRUTOSIDES IN ELDERLY PATIENTS WITH CHRONIC VENOUS INSUFFICIENCY - ITS EFFICACY AND TOLERABILITY

The efficacy and tolerability of O-(beta-hydroxyethyl)-rutosides (HR) in elderly patients (aged over 65 years) with chronic venous insuffici ency or varicose veins was studied in a multicentre, double-blind, ran domised, placebo-controlled trial. Of the 104 patients entered into th e trial, data from 102 were available for analysis of tolerability and from 86 for efficacy. Treatment was for 6 months, with monthly examin ations. Three different dosages were used due to slight differences in the registered dosage in various countries: (1) 250 mg 4 times daily( 1 g/day), UK, n = 19 patients; (2) 300 mg 3 times daily (900 mg/day), FRG and Belgium, n = 55, and (3) 300 mg 4 times daily (1,200 mg/day), The Netherlands, n = 30. Each centre had its own placebo control group . The HR-treated group (n = 41) showed a significantly greater reducti on in the total symptom score, 5.7 +/- 2.4 to 2.3 +/- 1.8, than in the placebo group, 4.4 +/- 3.0 to 3.0 +/- 2.4 (p < 0.01). Of the 5 studie d symptoms there was also a significant (p < 0.05) improvement in leg cramps, heavy legs and restless legs. No significant differences betwe en the two groups were seen for aching pains and paraesthesia. A small reduction was also seen in ankle and calf circumferences, which becam e significant at the end of the trial (p < 0.05). Pitting oedema of th e leg (p < 0.01) and eczema of the leg (p < 0.05) also improved signif icantly greater than in the control group. Tolerability, as reflected in adverse events and monitoring of a range of 31 laboratory tests, wa s comparable in the HR group to that of the placebo group. HR appears to be an effective and well-tolerated treatment for symptoms related t o chronic venous insufficiency or varicose veins in elderly patients.