Clinical benefits of Daflon 500 mg in the most severe stages of chronic venous insufficiency
ABSTRACT Chronic venous insufficiency (CVI) affects a large number of people in Western countries, and is responsible for considerable inconvenience, discomfort, suffering, and costs. Micronized purified flavonoid fraction (MPFF, 450 mg diosmin plus 50 mg hesperidin-Daflon 500 mg) is a potent venotropic drug used in the treatment of venous insufficiency. Pharmacological and clinical studies demonstrated the comprehensive mode of action of Daflon 500 mg: it increases venous tone, it improves lymph drainage, and it protects the microcirculation. Clinical international, prospective, multicenter, randomized, controlled studies versus placebo studies documenting the effects of Daflon 500 mg in CVI at advanced stages with edema, skin changes, and venous leg ulcer are reviewed. In edema, one of the most frequent complaints of patients, Daflon 500 mg brings about a significant reduction in leg circumference, thanks to its capacity to inhibit inflammatory reactions and to decrease capillary hyperpermeability. The rationale for the use of Daflon 500 mg for treatment of skin disorders and venous leg ulcer is its action on the microcirculation-damaging processes. Regarding skin changes, Daflon 500 mg has been shown to improve venous trophic disorders, like gravitational (stasis) dermatitis, and dermatofibrosclerosis. In venous leg ulcer, Daflon 500 mg's clinical efficacy has been demonstrated in addition to standard treatment or versus standard treatment alone. Daflon 500 mg, thanks to its comprehensive mode of action on the veins, lymphatics, and microcirculation, is the method of choice not only in the early stages of CVI treatment, but also in the severe stages of this condition, in combination with compression treatment, sclerotherapy, and surgery if appropriate.
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ABSTRACT: SUMMARY Background: Melanoma metastasizes in approximately one third of patients, causing a drop in survival of 1-2% at two years. The only effective treatment is Interferon alpha (IFN α) at elevated doses, which is highly toxic. Thus, less toxic antitumoral agents are being sought, among which fla- vonoids are to be highlighted. Our aim was to study the combined treatment of metastasic lung melanoma with IFN α and diosmin in a murine model. Material & Methods: 60 Swiss mice inoculated with cells (5 x 105) from the B16F10 murine melanoma cell line, treated over 11 days prior and 21 days following inoculation: Group I: ethanol + PBS; Group II: ethanol + IFN α (600,000 IU); Group III: ethanol + IFN α (1,200,000 IU); Group IV: dios- min + PBS; Group V: diosmin + IFN α (600,000 IU); Group VI: diosmin + IFN α (1,200,000 IU). Following treatment, animals were sacrificed and a macroscopic count of sub- pleural metastasic nodules was performed. Results: We found significant differences between the control and the treated groups (p
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ABSTRACT: Chronic venous insufficiency (CVI) occurs in a relatively large proportion of the population and is associated with significant morbidity, high cost of healthcare, loss of productivity and reduced quality of life. Lower extremity ulcers related to CVI have been estimated to affect 0.21% of the population in developed countries. The prevalence of venous ulcers in the US is estimated at 500 000600 000, and increases with age. Estimates of the annual incidence of leg ulcer in the UK and Switzerland are 3.5 and 0.2 per 1000 individuals, respectively. Treatment of venous ulcers can be expensive, leading to a large economic burden on health services in many countries. The annual cost of CVI is estimated to be more than $US1 billion in the US and between £400600 million in the UK. Current treatments for CVI include surgery, sclerotherapy, compressive therapy (conventional therapy) and adjuvant pharmacotherapy. Various pharmacological agents have been used as adjuvant therapy but in many cases there is no definitive evidence of their efficacy.Effective treatment programs for venous leg ulcers could substantially reduce the economic impact of CVI on health services. In controlled studies, micronized purified flavonoid fraction (MPFF) adjuvant therapy has been shown to increase significantly the number of healed venous leg ulcers and to reduce significantly the healing time of ulcers compared with conventional therapy alone, potentially leading to an improvement in patients quality of life. The treatment of venous leg ulcers with MPFF was also found to reduce overall treatment costs compared with conventional therapy alone. In a retrospective cost-effectiveness analysis based on direct medical costs only, MPFF therapy improved the cost-effectiveness ratio by 45% compared with conventional therapy. If intangible costs, such as loss of quality of life were included, the difference in cost-effectiveness ratios is likely to be even greater in favor of MPFF. Sensitivity analyzes showed that even with a 20% increase in drug price the cost-effectiveness ratio for MPFF therapy was substantially better than that for conventional therapy ($US1061.8 vs 1871.9 per ulcer healed). Hence, the addition of MPFF adjuvant therapy to the treatment of venous leg ulcers would be effective and potentially cost saving.American Journal of Clinical Dermatology 12/2002; 4(8):573-581. DOI:10.2165/00128071-200304080-00007 · 2.52 Impact Factor
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ABSTRACT: Micronised purified flavonoid fraction (MPFF) [Daflon 500 mg], an oral phlebotropic drug consisting of 90% micronised diosmin and 10% flavonoids expressed as hesperidin, improves venous tone and lymphatic drainage, and reduces capillary hyperpermeability by protecting the microcirculation from inflammatory processes. The absorption of diosmin is improved by its micronisation to particles with a diameter <2 microm. Compared with placebo, MPFF 500 mg twice daily significantly decreased ankle or calf circumference, and improved many symptoms of chronic venous insufficiency (CVI) and plethysmographic parameters in two randomised, double-blind, 2-month studies. Improvement in symptoms was parallelled by an improvement in health-related quality of life in a nonblind, 6-month trial. Significantly more venous leg ulcers </=10 cm in diameter completely healed with MPFF 500 mg twice daily plus standard management (compression and local treatment) for 2-6 months than with standard management alone or with placebo in a nonblind and a double-blind trial. The addition of MPFF to standard management was cost effective in a retrospective pharmacoeconomic analysis of the 6-month trial. Compared with placebo, the duration and/or intensity of individual symptoms of grade 1 or 2 acute internal haemorrhoids improved significantly with 3 tablets of MPFF 500 mg twice daily for 4 days then 2 tablets of MPFF 500 mg twice daily for 3 days. Two tablets of MPFF 500 mg daily for 60 or 83 days reduced the frequency, duration and/or severity of acute haemorrhoidal symptoms and improved the overall signs and symptoms of chronic (recurrent) haemorrhoids compared with placebo. Compared with a control group, MPFF significantly reduced the risk of secondary bleeding after elective haemorrhoidectomy. In clinical trials, MPFF had a tolerability profile similar to that of placebo; the most frequently reported adverse events were gastrointestinal and autonomic in nature. In conclusion, MPFF is a well established and well tolerated treatment option in patients with CVI, venous ulcers, or acute or chronic internal haemorrhoids. MPFF is indicated as a first-line treatment of oedema and the symptoms of CVI in patients in any stage of the disease. In more advanced disease stages, MPFF may be used in conjunction with sclerotherapy, surgery and/or compression therapy, or as an alternative treatment when surgery is not indicated or is unfeasible. The healing of venous ulcers </=10 cm in diameter is accelerated by the addition of MPFF to standard venous ulcer management. MPFF may reduce the frequency, duration and/or intensity of symptoms of grade 1 or 2 acute internal haemorrhoids, and also the severity of the signs and symptoms of chronic haemorrhoids.Drugs 02/2003; 63(1):71-100. DOI:10.2165/00003495-200363010-00005 · 4.13 Impact Factor