Methods and compositions using sulodexide for the treatment of diabetic nephropathy
a technology of sulodexide and composition, applied in the field of methods and compositions using sulodexide for the treatment of diabetic nephropathy, can solve the problems of ineffectiveness, unsatisfactory effect, and inability to improve the condition of two patients with microalbuminia, and achieve the effect of not being effective, reducing the risk of heparin like effects, and reducing the effect of sulodexid
Inactive Publication Date: 2008-02-21
ALFA WASSERMANN INC
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Benefits of technology
"The present invention is about a new pharmaceutical composition that can help treat diabetic nephropathy. It contains a specific amount of a drug called Sulodexide, which is safe and effective in reducing the amount of albumin excreted in urine. This composition can be made into a pill or liquid form for patients to take. The dosage of Sulodexide is unique and has been found to improve the condition of patients with diabetic nephropathy without causing any harmful side effects. This invention offers a new treatment option for patients with diabetic nephropathy."
Problems solved by technology
Two of the patients with microalbuminia did not get any improvement.
The art concerning the use of Sulodexide to treat vascular conditions teaches that doses of 100 mg / day or 1000 LRU's or less are effective and that higher doses may produce unwanted or dangerous heparin like effects.
However, doses in the range of 100 mg. / day (10000 LRU's) or less, have not proved effective in all subjects with diabetic nephropathy and have not been shown to produce lasting improvement in the albumin excretion rate in treated patients.
Method used
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[0041] Oral Treatment of Albuminuria in Nephropathic Diabetic Patients with Sulodexide.
[0042] The objective of this study was to evaluate the efficacy of three dose regimens of oral Sulodexide versus placebo, in both DM1 and DM2 patients with diabetic nephropathy and albuminuria.
[0043] The experimental methodology was to randomly divide 240 patients with diabetic nephropathy and albuminuria into four groups. These groups received treatment with placebo or with oral Sulodexide at doses of 50, 100 or 200 mg per day. The active treatment phase was four months long and this was followed by an additional post treatment follow up after four months. The assignment and treatment of the patients was done in a double blind fashion.
[0044] Inclusion criteria for the study required a stable blood pressure of less than 160 / 90, a serum creatinine of less than 50 μmol / L, proteinuria of less than 3 g / day and stable HgBA1C.
[0045] The primary end point changes in albumin excretion rate (AER) were ...
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Abstract
The present invention provides oral formulations of Sulodexide for the treatment of diabetic nephropathy in patients with both insulin dependent and non-insulin dependent diabetes mellitus. Oral formulations containing doses adapted for administration to obtain a reduction in albumin. excretion in patients with both micro and macro albuminuria and to produce lasting improvement in albumin excretion rate are provided. Methods of treating diabetic nephropathy using these formulations are also provided.
Description
[0001] This non-provisional application claims the priority benefit of U.S. Provisional Application No. 60 / 209,907, which was filed on Jun. 7, 2000.FIELD OF THE INVENTION [0002] The present invention relates to pharmaceutical compositions comprising Sulodexide in specific dosages and methods of using specific dosages of Sulodexide for the treatment of patients with diabetic nephropathy and albuminuria caused by, for example, insulin dependent or non-insulin dependent Diabetes Mellitus. BACKGROUND OF THE INVENTION [0003] The use of glycosaminoglycans, such as heparin, in various anticoagulant and antithrombotic therapies is well known. Sulodexide is a glycosaminoglycan of natural origin extracted from mammalian intestinal mucosa that posses an anticoagulant activity. Sulodexide has a sulfation degree lower than those of heparin, as shown by Radhakrishnamurthy B. et al., Atherosclerosis, 31, 217-229 (1978). The preparation of Sulodexide is described in U.S. Pat. No. 3,936,351,(incorpo...
Claims
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IPC IPC(8): A61K31/726A61K9/10A61K9/20A61K9/48A61K9/64A61K31/00A61K31/70A61P13/12C08B37/00
CPCA61K9/48A61K31/70A61K31/726A61K31/727A61K31/737A61K35/38A61K2300/00A61P13/12
Inventor PALAZZINI, ERNESTOGAMBARO, GIOVANNI
Owner ALFA WASSERMANN INC