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The objective of the present study was to investigate the effects of a purified micronized flavonoid fraction (Daflon 500 mg) on the increased capillary filtration of albumin (CFA) which is an early change in the microcirculation of patients with diabetes. A placebo controlled trial lasting 30 to 42 days including two equal groups of 20 patients, following a 15-day initial placebo run-in phase. The CFA test employed consisted of injecting albumin labelled with technetium (99mTc) intravenously, applying a venous tourniquet to one arm, and counting the radioactivity on the ipselateral forearm using an external gamma camera. The disappearance of radioactivity was analysed by means of two parameters after the tourniquet had been released, i.e. albumin retention (AR) and the LF/HF index which indicates lymphatic function in interstitial protein clearance. All patients included exhibited an increase in these two indices before the initial placebo run-in phase and at the end of the run-in period. At the end of the treatment phase, AR had significantly decreased in the group treated by the flavonoid fraction (FF) by comparison with the placebo group, and had normalized in 65% of patients in the FF group, compared with 25% of patients in the placebo group (p = 0.010). The LF/HF index normalized in 55% of cases in the FF group, compared with no patients on placebo (p = 0.00001). This study suggests that the flavonoid fraction tested here can improve and even normalize capillary filtration of albumin in diabetic patients.

Unlabelled: Drugs for long term administration have to prove their efficacy and safety. Previously published double blind controlled studies (from single dose to two months treatment) have already demonstrated the phlebotropic activity of Daflon 500 mg in chronic venous insufficiency (CVI). The aim of the study was to investigate the safety of this agent during one year of continuous administration. Two-hundred and fifteen out-patients suffering from CVI received Daflon 500 mg, 2 tablets per day. Therapeutic activity was evaluated every 2 months on: 1) venous symptoms (functional discomfort, cramps, evening oedema) assessed by a 0 to 4 scale; 2) supramalleolar and calf circumferences; 3) overall assessment of efficacy (excellent, useful, nil). Acceptability was assessed by recording the side effects and measuring laboratory parameters., Results: 170 patients completed the study. Functional symptoms were statistically significantly improved as shown by the following: functional discomfort: 0.55 +/- 0.06 vs 2.63 +/- 0.06, supra-malleolar circumference in cm: 22.5 +/- 0.2 vs 23.1 +/- 0.2, and calf circumference in cm: 34.7 +/- 0.3 vs 35.2 +/- 0.3. This improvement in the symptoms quickly appeared from the first control (M2) and reached about 50% of the total decrease. Overall assessment of efficacy was evaluated as follows: excellent = 58%, useful = 33%, nil = 9% of the cases. Laboratory parameters remained constant during the 12 months. Side effects were essentially gastralgia (n = 7). According to these results, it appears the efficacy and safety of Daflon 500 mg are corroborated even after a one year administration.

Microcirculatory disorders are often a complication of diabetes. They are associated with an increased capillary permeability which can be assessed by the Landis test using 99mTc-labelled albumin. Labelled albumin retention is measured by external detection (residual radioactivity after removal of venous tourniquet). The Fast Fourier Transform of the radioactivity disappearance graph reflects the lymphatic albumin resorption. Thirteen out-patients with diabetes from 1 to 19 years suffering from evident microcirculatory disorders were treated with a micronized flavonoid fraction: Daflon 500 mg (2 tablets per day) during a month. Antihypertensive and/or antidiabetic treatment were continued during the study if they were given before starting. A test was performed before, and at the end of the treatment. In 10 of the 13 patients, the test was carried out a third time 5.5 +/- 1.0 months later, after treatment withdrawal. Results were as follows: 1) labelled albumin retention was abnormal (greater than or equal to 8%) at the start and became normal in the patients and improved in 1 patient. After treatment withdrawal, the results of the third test were again abnormal, in the patients who had been normalized beforehand; 2) the initially abnormal lymphatic resorption became normal in six of the 13 patients at the end of the treatment and became abnormal again in all patients after treatment withdrawal. In a parallel group of 15 patients with abnormal test lymphatic fluctuations and not being treated with a vasculo-protector agent, the initially abnormal test remained abnormal 5 to 48 months later in all patients.(ABSTRACT TRUNCATED AT 250 WORDS)