The term "medical food" means a food which is formulated to be consumed or administered enterally (by mouth or feeding tube) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. (source: 21 U.S.C. sec. 360ee(b)(3). -- [from the Orphan Drug Act, 1988]
Since the components of Vasculera are purified chemicals found in foods, there is no need for this to be a drug. As required of all products classified as medical foods, the ingredients in Vasculera have been determined to be generally recognized as safe (GRAS), a food safety distinction at the FDA.
Vasculera is a 630mg tablet of diosmiplex, which is a combination of diosmin (600mg) and alka4-complex (30mg).
Diosmin is semi-synthetically produced from hesperidin, another flavonoid found in citrus. Diosmin is also found at low concentrations in oranges and some other citrus fruits in both the rind and juice (see the USDA flavonoid database). Alka4-complex is an antacid produced by mixing certain bases found in other products in such a way so that it can survive harsh environment of stomach acid and be absorbed through the small intestine into the blood.
Half-life is the period of time it takes for half of an ingested dose to be eliminated from the body. The mean half-life for Vasculera is 31.5 hours. This justifies the once a day dosing.
Vasculera acts by restoring toward normal the metabolic aspects of CVI, including modulation of venous tone and capillary resistance, management of lymphatic drainage, venous acidosis and inflammation in the microcirculation. Vasculera manages manifestations of CVI, including hemorrhoidal disease, by managing the vascular integrity of the veins and inflammation in the microcirculation.
Vasculera is indicated for the clinical dietary management of the metabolic processes of Chronic Venous Insufficiency (CVI) under physician supervision. This means that Vasculera can be used to help manage other forms of CVI besides hemorrhoids including varicose veins, spider veins, edema, lymphedema, traveler’s edema, stasis dermatitis, and venous ulcers.
Extensive published and peer-reviewed clinical studies exist on diosmin, the primary ingredient in Vasculera, to show safety and efficacy. There are dozens of clinical studies demonstrating that the diosmin in Vasculera manages CVI of the legs:
Carpentier PH and Mathieu M. Evaluation of clinical efficacy of a venotonic drug: lessons of a therapeutic trial with hemisynthetic diosmin in “heavy legs syndrome”. J Mal Vasc. 1998.23;106-12
Danielsson G, Jungbeck C Peterson K and Norgren L. A randomized controlled trial of micronised purified flavonoid fraction vs placebo in patients with chronic venous disease. Eur J VascEndovasc Surg. 2002.23;73-6
Geroulakos G and Nicolaides AN. Controlled studies of Daflon 500 mg in chronic venous insufficiency. Angiology. 1994.45;549-53
Guilhou JJ, Dereure O, Marzin L et al. Efficacy of Daflon 500 mg in venous leg ulcer healing: a double-blind, randomized, controlled versus placebo trial in 107 patients. Angiology. 1997.48;77085
Ibegbuna V, NicolaidesAN,Sowade O et al. Venous elasticity after treatment withDaflon 500 mg. Angiology. 1997.48;45-9
Jantet Georges. RELIEF Study: First Consolidated European Data. Angiology. 2000.51;31-37
Jantet G and the Relief Study Group. Chronic Venous Insufficiency: Worldwide Results of the RELIEF Study. Angioogy. 2002.53;245-56
Labrid C. A lymphatic function of Daflon 500 mg. Int Angiol. 1995.14;36-8
Lyseng-Williamson KA and Perry CM. Micronised Purified Flavonoid Fraction: A review of its Use in Chronic Venous Insufficiency, Venous Ulcers and Haemorrhoids. Drugs. 2003.63;71-100
Olszewski W. Clinical efficacy of micronized purified flavonoid fraction (MPFF) in edema. Angiology. 2000.51;25-9
Ramelet AA. Pharmacologic aspects of a phlebotropic drug in CVI-asociated edema. Angiology. 2000.51;19-23
Ramelet AA. Clinical benefits of Daflon 500 mg in the most severe stages of chronic venous insufficiency. Angiology. 2001.52;S49-56
Roztocil K, Stvrtinova V, and Strejcek J. Efficacy of a 6-month treatment with Daflon500 mg in patients with venous leg ulcers associated with chronic venous insufficiency. IntAngiol. 2003.22;24-31
Smith PC. Daflon 500 mg and venous leg ulcer: new results from a meta-analysis. Angiology. 2005.56;S33-9
Struckmann JR and Nicolaides AN. Flavonoids: A review of the pharmacology and therapeutic efficacy of Daflon 500 mg in patients with chronic venous insufficiency and related disorders. Angiology. 1994.45;419-28
Valensi PE, Behar A, de Champvallins MM et al. Effects of a purified micronized flavonoid fraction on capillary filtration in diabetic patients. Diabet med.1996.13;882-9
The principle studies typically referenced to show the efficacy of diosmin in the management of hemorrhoids are:
Cospite M. Double-blind, placebo-controlled evaluation of clinical activity and safety of Daflon 500 mg in the treatment of acute hemorrhoids. Angiology. 1994 Jun; 45(6 Pt 2):566-73.
Godeberge P. Daflon 500 mg in the treatment of hemorrhoidal disease: a demonstrated efficacy in comparison with placebo. Angiology. 1994 Jun; 45(6 Pt 2):574-8.
Thanapongsathorn W and Vajrabukka T. Clinical trial of oral diosmin (Daflon) in the treatment of hemorrhoids. Dis Colon Rectum. 1992.35;1085-8
Vasculera is a new product to the market. Diosmin, the primary ingredient in Vasculera, has been used in other parts of the world for more than twenty years. Recently, Vasculera was added as part of a kit marketed in the United States for hemorrhoids, the Analpram Advanced Kit®.
Vasculera has a GRAS (Generally Recognized as Safe) recommendation of use for up to more than a year depending on the physician’s dosing recommendations.
Similar products have shown no serious adverse events reported in any study. Commonly reported side effects related to consumption of diosmin included gastrointestinal disturbances and headaches, which were generally mild and did not result in discontinuation. Please see Vasculera package insert for further information.
Vasculera is contraindicated for anyone having a hypersensitivity to any of its ingredients.
Drug interactions have been described with chlorzoxazone (Parafon Forte), diclofenac (Voltaren) and metronidazole (Flagyl). These reports were based on pharmacokinetic studies although clinical reports of drug interactions exist.
Vasculera is not recommended for pregnant or lactating women or patients with a history of cancer since there has not been appropriate research conducted in these patient populations.
The recommended intake of VASCULERA (diosmiplex) is 1 tablet per day for the dietary management of Chronic Venous Insufficiency (CVI), manifested as: varicose/spider veins, edema, stasis dermatitis and or venous ulcers. Results may appear in as little as one week but may not be seen for 4 to 8 weeks. For venous ulcers, results may not be seen for several months.
For hemorrhoidal disease, the recommended initial intake is 1 tablet 3 times daily for 4 days followed by 1 tablet twice daily for 9 days, or as directed by a physician. For hemorrhoidal discomfort persisting after resolution of the acute flare or for recurrent hemorrhoidal flares irrespective of persisting discomfort, a maintenance intake of one tablet of Vasculera daily is recommended.