Micronised Purified Flavonoid Fraction

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Abstract
Micronised purified flavonoid fraction (MPFF) [Daflon® 500mg1], 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 10cm in diameter did not completely heal in either the active-treatment or placebo group during the 2-month trial. Compared with the control group in the longer trial, MPFF reduced mean ulcer area (80 vs 65%) and discomfort related to ulcer (64.8 vs 38.3% of patients); this trial did not include ulcers >10cm in diameter. In a retrospective pharmacoeconomic analysis of the 6-month trial, 2 tablets of MPFF 500mg daily was cost-effective in the treatment of venous ulcers compared with the control group receiving standard venous ulcer treatment. Based on the cost per healed ulcer over 6 months, the cost-effectiveness ratio in the MPFF group was 1026 euros (EUR) compared with EUR1872 in the control group (year of costing 1998). In Patients with Haemorrhoids: In two randomised, double-blind, placebocontrolled trials, MPFF 500mg (3 tablets twice daily for 4 days then 2 tablets twice daily for 3 days) significantly reduced the duration and/or intensity of symptoms of acute internal haemorrhoids (e.g. bleeding, pain, and anal discharge) compared with placebo. After the first few days of treatment, systemic and topical anaesthetics were used less by patients receiving MPFF than patients receiving placebo. In two double-blind trials, treatment with MPFF 500mg twice daily for 60 or 83 days reduced the frequency, duration and/or severity of acute haemorrhoidal symptoms in patients with chronic symptoms of haemorrhoids compared with placebo. Relapses of bleeding were prevented in 18 or 36% more patients receiving MPFF than those receiving placebo; MPFF also effectively treated the symptoms and signs of chronic haemorrhoids. In a randomised, nonblind trial, MPFF 500mg (3 tablets twice daily for 5 days, then 2 tablets twice daily for 3 weeks) plus fibre (ispaghula husk) resolved bleeding from nonprolapsed internal haemorrhoids as effectively as with rubber band ligation plus fibre and more rapidly than with fibre alone. In a noncomparative trial in pregnant women, MPFF 500mg (6 tablets daily for 4 days, then 4 tablets for 3 days) reduced median symptom scores for bleeding, pain, rectal discomfort and rectal exudation from baseline. Maintenance treatment with MPFF 500mg twice daily in the antenatal and 30-day postnatal periods reduced the duration of relapses of symptoms of acute haemorrhoids compared with the patient’s history. The proportion of patients with secondary postoperative bleeding after open pedicular haemorrhoidectomy was less in patients receiving MPFF 500mg (2 tablets three times daily for 3 days then 1 tablet three times daily for 4 days) than in the control group (0.9 vs 6.1%). In clinical trials, MPFF was well tolerated with most reported events being mild and transitory. The adverse events most commonly associated with MPFF are gastrointestinal (e.g. abdominal pain, gastric discomfort, nausea, dyspepsia, vomiting and diarrhoea) or autonomic (e.g. insomnia, drowsiness, vertigo, headache and tiredness) in nature. Combined data from clinical trials in patients with CVI or haemorrhoids indicated that the incidence of adverse events was similar in 2850 patients receiving 2 tablets of MPFF 500mg daily and 225 patients receiving placebo (10 vs 13.9% of patients). Gastrointestinal and autonomic events were reported by 6.9 and 1.7% of patients receiving MPFF. Adverse events were the reason for discontinuation in the trials of 1.1 % of MPFF recipients compared with 3.2% of placebo recipients. The incidence or nature of adverse events was not changed by long-term treatment (1 year) with 2 tablets of MPFF 500mg daily, dosages of MPFF 500mg of up to 6 tablets daily for 7 days, age ≥70 years or the presence of concomitant diseases (i.e. hypertension, atherosclerosis, diabetes mellitus, neurological/psychiatric disease or alcoholism). Two tablets of MPFF 500mg daily for 1 year did not modify blood pressure or laboratory parameters. MPFF is available as 500mg tablets and is administered orally. Prescribing information for MPFF may differ between the more than 100 countries (including 9 countries in the EU and 20 other European countries) that have approved its use. In general, MPFF is indicated for the treatment of organic or idiopathic CVI of the lower limbs with symptoms of heavy legs, pain or nocturnal cramps, acute haemorrhoidal attacks or chronic haemorrhoids. In CVI, the recommended dosage is 2 tablets daily (as a single dose in the morning or evening or 1 tablet twice daily); in acute haemorrhoidal attacks, 2 tablets three times daily for 4 days followed by 2 tablets twice daily for 3 days; and in chronic haemorrhoids, 2 tablets daily. MPFF does not interact with any drugs. Caution is recommended when administering MPFF to patients who are breast feeding.