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Symposium - UIP 2005

The Relief Study

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Product Description Indication DAFLON 500 mg is an oral phlebotropic drug indicated in the treatment of venous disease, ie, chronic venous disease and hemorrhoidal disease (HD). Origin and composition of DAFLON 500 mg DAFLON 500 mg is a unique micronized purified flavonoid fraction (MPFF) containi ng 90% diosmin and 10% flavonoids expressed as Hesperidin. Hesperidin is extract ed from a species of Rutaceae aurantieae of the citrus genus, a type of immature small orange harvested and dried in Spain, North Africa, and China. Diosmin, a member of the flavonoid family, is synthesized starting from this raw material.1 ,2 Why is the micronized form of DAFLON 500 mg important? Micronization means that the active ingredient of DAFLON 500 mg undergoes a high

-tech grinding process with a jet of air at supersonic velocities, reducing the size of standard particles from 37 m to less than 2 m. Than s to its micronized fo rm, DAFLON 500 mg has better and faster absorption, and thus an increased bioava ilability, which leads to faster and superior clinical efficacy in chronic venou s disease management.3-7 How does DAFLON 500 mg act? DAFLON 500 mg has a unique and rigorously demonstrated mode of action, which ena bles it to fight simultaneously all the pathophysiological aspects of venous dis ease, affecting the veins, lymphatics, and microcirculation. 1. Veins DAFLON 500 mg prolongs the vasoconstrictor effect of noradrenaline on the vein w all, even under warm and acidotic conditions, increasing venous tone, and theref ore reducing venous capacitance, distensibility, and stasis. This increases the venous return and reduces venous hyperpressure present in patients suffering fro m chronic venous disease. At the macrocirculatory level, DAFLON 500 mg has been recently proven to protect the venous valves from leu ocyte-induced destruction, preventing the appearance of reflux, and therefore protecting against the progr ession of chronic venous disease toward complications. 8 2. Lymphatics DAFLON 500 mg improves lymphatic drainage by increasing the frequency and intens ity of lymphatic contractions, and by increasing the total number of functional lymphatic capillaries. Furthermore, DAFLON 500 mg decreases the diameter of lymp hatic capillaries and the intralymphatic pressure.9,10 3. Microcirculation At the microcirculation level, DAFLON 500 mg reduces capillary hyperpermeability and increases capillary resistance by protecting the microcirculation from dama ging processes. DAFLON 500 mg reduces the expression of adhesion molecules on en dothelial cells (ICAM1, VCAM1)11 and on leu ocytes (L-selectin, VLA-4, CD 11b),8 and inhibits the adhesion, migration, and activation of leu ocytes at the capil lary level. This leads to a reduction in the release of inflammatory mediators, principally oxygen free radicals and prostaglandins (PGE2, PGF2a).12-18 This protective and reinforcing action on the venous and lymphatic system, assoc iated with the vasculoprotective effect on the macro- and the microcirculation, explains the restorative and protective efficacy of DAFLON 500 mg in chronic ven ous disease and hemorrhoidal disease, both of which are associated with perivasc ular inflammation and edema. Has DAFLON 500 mg demonstrated its clinical efficacy in chronic venous disease? In patients suffering of chronic venous disease, DAFLON 500 mg provides signific ant relief from disabling symptoms,18-20 such as pain, heavy legs, cramps, and s ensation of swelling. Moreover, DAFLON 500 mg also significantly improves clinic al signs, such as leg edema,20,21 s in disorders,22 and venous leg ulcer.23,24

This improvement of signs and symptoms contributes to a significant increase in patients' quality of life, as assessed with a validated international scale spec ific to chronic venous disease: the CIVIQ questionnaire.19 Can DAFLON 500 mg be useful in treating complications of chronic venous chronic venous disease? 1. Venous leg ulcer

In venous ulcer, DAFLON 500 mg, 2 tablets daily is an effective adjunct to conve ntional therapy (compression and local care) that increases the chance of healin g leg ulcer by at least 32% at 6 months, and shortens ulcer healing time by 5 we e s. Large and long-standing ulcers (>5 cm and >6 months) are found to benefit mo st from adjunctive therapy with DAFLON 500 mg, these ulcers being slow and more difficult to heal.23-25 2. Postsurgical and postradiotherapy lymphedema Administration of DAFLON 500 mg, 2 tablets daily, for 6 months in patients who h ad lymphedema after breast cancer surgery leads to a 1.5% to 13.4% decrease in c ircumference of the affected arm, an improvement in tissue elasticity, and an im provement in lymphatic drainage functional parameters, evaluated by isotope scan .26 Another double-blind, placebo controlled study, with an equal treatment peri od and dosage, demonstrated that DAFLON 500 mg induces and increases the velocit y of lymphatic drainage on isotope scan, improves functional disturbances, and c onstantly decreases the volume of the affected arm.27 What about the efficacy of DAFLON 500 mg in hemorrhoidal disease? In acute hemorrhoidal attac s, DAFLON 500 mg is highly effective, right from the second day of treatment, in improving all signs and symptoms, such as bleeding, pain, discharge, tenesmus, and proctitis, thereby reducing the consumption of o ral analgesics.28,29 The efficacy of DAFLON 500 mg associated with fiber supplement has been superior to fiber supplement alone and equivalent to rubber-band ligation plus fiber sup plement in stopping anal bleeding due to hemorrhoids.30 DAFLON 500 mg combined with an infrared photocoagulation technique (IRP) is more effective in rapidly stopping bleeding than IRP alone.31 DAFLON 500 mg combined with hemorrhoidectomy significantly reduces the ris of p ostoperative bleeding and reduces the postoperative healing time.32,33 In long-term treatment for chronic hemorrhoidal disease, DAFLON 500 mg has been proven to significantly reduce recurrence, duration, number, and severity of hem orrhoidal attac s.29,32 What is the dosage of DAFLON 500 mg? Chronic venous disease: 2 tablets daily Hemorrhoidal disease: - Hemorrhoidal attac s: 6 tablets daily for 4 days followed by 4 tab lets daily for 3 days - Chronic hemorrhoids: 2 tablets daily