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 . The pharmaceutical composition of claim 3 , characterized in that the HMG-CoA reductase inhibitor is Atorvastatin.
5 . The pharmaceutical composition of claim 3 , characterized in that the HMG-CoA reductase inhibitor is calcium Atorvastatin.
6 . The pharmaceutical composition of claim 5 , characterized in that the HMG-CoA reductase inhibitor is Lipitor®.
7 . The pharmaceutical composition of claim 3 , characterized in that the HMG-CoA reductase inhibitor is Rosuvastatin.
8 . The pharmaceutical composition of claim 7 , characterized in that the HMG-CoA reductase inhibitor is Crestor®.
9 . The pharmaceutical composition of claim 3 , characterized in that the HMG-CoA reductase inhibitor is Mevinolin.
10 . The pharmaceutical composition of claim 3 , characterized in that the HMG-CoA reductase inhibitor is Nivastatin.
11 . The pharmaceutical composition of claim 3 , characterized in that the HMG-CoA reductase inhibitor is Simvastatin.
12 . The pharmaceutical composition of claim 11 , characterized in that the HMG-CoA reductase inhibitor is Zocor®.
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 . The pharmaceutical composition of claim 15 , characterized in that the polychitosamine has a molecular weight of about 40 kDa.
17 . The pharmaceutical composition of claim 16 , characterized in that the polychitosamine is HEP40®.
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 . The pharmaceutical composition of claim 1 , characterized in that the therapeutically effective amount of the HMG-CoA reductase inhibitor is about 6 mg to about 80 per day and wherein the therapeutically effective amount of the polychitosamine is about 600 mg to about 2400 mg per day.
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 18 , 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 18 , 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 . The method of claim 18 , characterized in that the HMG-CoA reductase inhibitor is Atorvastatin.
25 . The method of claim 18 , characterized in that the HMG-CoA reductase inhibitor is calcium Atorvastatin.
26 . The method of claim 20 , characterized in that the HMG-CoA reductase inhibitor is Lipitor®.
27 . The method of claim 18 , characterized in that the HMG-CoA reductase inhibitor is Rosuvastatin.
28 . The method of claim 27 , characterized in that the HMG-CoA reductase inhibitor is Crestor®.
29 . The method of claim 23 , characterized in that the HMG-CoA reductase inhibitor is Mevinolin.
30 . The method of claim 23 , characterized in that the HMG-CoA reductase inhibitor is Nivastatin.
31 . The method of claim 23 , characterized in that the HMG-CoA reductase inhibitor is Simvastatin.
32 . The method of claim 31 , characterized in that the HMG-CoA reductase inhibitor is Zocor®.
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 . The method of claim 21 , characterized in that the polychitosamine has a molecular weight of about 40 kDa.
37 . The method of claim 36 , characterized in that the polychitosamine is HEP40®.
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 . The method of claim 21 , characterized in that the therapeutically effective amount of the HMG-CoA reductase inhibitor is about 6 mg to about 80 per day and wherein the therapeutically effective amount of the polychitosamine is about 600 mg to about 2400 mg per day.
41 . The method of claim 40 , characterized in that the therapeutically effective amounts of the HMG-CoA reductase inhibitor and the therapeutically effective amount of the polychitosamine are administered once a day.
42 . The method of claim 40 , characterized in that the therapeutically effective amounts of the HMG-CoA reductase inhibitor and the therapeutically effective amount of the polychitosamine are administered twice a day.
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.