COMBINATION OF POLYCHITOSAMINE AND HMG-COA REDUCTASE INHIBITOR FOR HYPERLIPIDEMIA
Combinations of therapeutic compounds for prophylaxis or treatment of hyperlipidemia and hyperlipidemia related disorders, such as hypercholesterolemia and the resultant atherosclerosis in a mammal. The combinations are useful for reducing serum cholesterol, and/or cholesteryl ester, triglycerides, phospholipids and fatty acids in a mammal. The methods of the preferred embodiments comprise administering to a mammal a first amount of polychitosamine and a second amount of an HMG-CoA reductase inhibitor (statin).
1 . A pharmaceutical composition comprising:
a) an HMG-CoA reductase inhibitor; and
b) a polychitosamine.
2 . The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable carrier.
3 . The pharmaceutical composition of claim 1 , characterized in that the HMG-CoA reductase inhibitor is selected from the group consisting of Lovastatin, Simvastatin, Pravastatin, Fluvastatin, Atorvastatin, Mevinolin, Rosuvastatin, Nivastatin, calcium Atorvastatin and Mevastatin.
4 - 12 . (canceled)
13 . The pharmaceutical composition of claim 1 , characterized in that the polychitosamine has a molecular weight of about 30 kDa and is deacetylated at least about 93%.
14 . The pharmaceutical composition of claim 1 , characterized in that the polychitosamine is Libracol®.
15 . The pharmaceutical composition of claim 1 , characterized in that the polychitosamine has a molecular weight ranging between 35 and 50 kDa.
16 - 17 . (canceled)
18 . The pharmaceutical composition of claim 1 , characterized in that the therapeutically effective amount of the HMG-CoA reductase inhibitor is about 6 mg per day.
19 . The pharmaceutical composition of claim 1 , characterized in that the therapeutically effective amount of the polychitosamine is at least about 400 mg per day.
20 . (canceled)
21 . A method for the prophylaxis or treatment of hyperlipidemia or hyperlipidemia-associated condition comprising administering to said patient:
a) a first amount of a polychitosamine; and
b) a second amount of an HMG-CoA reductase inhibitor;
wherein the first and second amounts together comprise a therapeutically effective amount.
22 . The method of claim 21 , characterized in that the hyperlipidemia-associated condition is selected from the group consisting of hypercholesterolemia, atherosclerosis, coronary heart disease, cardiovascular disease and post heart attack recovery.
23 . The method of claim 21 , characterized in that the HMG-CoA reductase inhibitor is selected from the group consisting of Mevinolin, Lovastatin, Simvastatin, Pravastatin, Fluvastatin, Atorvastatin, Rosuvastatin, Nivastatin, calcium Atorvastatin and Mevastatin.
24 - 32 . (canceled)
33 . The method of claim 23 , characterized in that the polychitosamine has a molecular weight of about 30 kDa and is deacetylated at least about 93%.
34 . The method of claim 21 , characterized in that the polychitosamine is Libracol®.
35 . The method of claim 21 , characterized in that the polychitosamine has a molecular weight ranging between 35 and 50 kDa.
36 - 37 . (canceled)
38 . The method of claim 21 , characterized in that the therapeutically effective amount of the HMG-CoA reductase inhibitor is at least about 6 mg per day.
39 . The method of claim 21 , characterized in that the therapeutically effective amount of the polychitosamine is at least about 400 mg per day.
40 - 42 . (canceled)
43 . A kit for the prophylaxis or treatment of hyperlipidemia or hyperlipidemia-associated condition in a mammal comprising a plurality of daily doses of dosage forms of an HMG-CoA reductase inhibitor, a plurality of daily doses of dosage forms of a polychitosamine together, and treatment regimen instructions.
44 . The kit of claim 43 , characterized in that the plurality of daily doses comprises separate daily doses of the HMG-CoA reductase inhibitor and separate daily doses of the polychitosamine.
45 . The kit of claim 43 , characterized in that the HMG-CoA reductase inhibitor is provided in dose units ranging from 2 mg to 80 mg.
46 . The kit of claim 43 , characterized in that the polychitosamine is provided in dose units ranging from 200 mg to 1200 mg.