A long term treatment with a venotropic drug. Results on efficacy and safety of Daflon 500 mg in chronic venous insufficiency.

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.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.