RAPIDLY IMPROVING VASCULAR CONDITIONS BY ADMINISTERING VITAMIN K

• US 20190328683A1
• Filed: 04/01/2019
• Published: 10/31/2019
• Est. Priority Date: 03/30/2018
• Status: Active Grant

• Current Assignee: Nattopharma R&D Limited
• Original Assignee: Kaydence Pharma AS
• Inventors: CHLOPICKI, Stefan, MARESZ, Katarzyna
• Granted Patent: US 11,911,349 B2
• Time in Patent Office: Days
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/326 having effect on cardiovascular health
• CPC Class Codes: A23V 2250/7142 Vitamin K1
• CPC Class Codes: A23V 2250/7144 Vitamin K2
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/122 having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• CPC Class Codes: A61K 31/592 9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
• CPC Class Codes: A61K 31/593 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

A method for rapidly improving cardiovascular function, reducing arterial stiffness and reversing calcification of a blood vessel in a mammal comprising administering to the mammal an effective amount of vitamin K for a period of less than 6 months. Also a method for increasing endothelial nitric oxide production in mammals comprising administering to the mammal an effective amount of vitamin K for a period of less than 6 months. The vitamin K can be administered together with additional substances such as vitamin D.

Claims

1. A method for improving cardiovascular function, elasticity, pulse wave velocity or endothelial dysfunction, reducing arterial stiffness and/or for reversing calcification of a blood vessel in a mammal, comprising administering to the mammal an effective amount of vitamin K for a period of less than 6 months.

2. The method according to claim 1, wherein said vitamin K is vitamin K2 and/or vitamin K1.

3. The method according to claim 1, wherein said vitamin K is a combination of vitamin K1 and vitamin K2.

4. The method according to claim 1, wherein said vitamin K is menaquinone-7.

5. The method according to claim 1, wherein said mammal is suffering from a disease selected from the group consisting of CKD, arteriosclerosis, osteoarthritis, inflammation-induced calcification, tumor-induced calcification, skin calcification, and calcifylaxis in end-stage renal disease, and/or wherein said mammal has received a kidney transplant.

6. The method according to claim 5, wherein said arteriosclerosis is Monckeberg'"'"'s sclerosis, said inflammation-induced calcification is Bechterev'"'"'s disease, or said skin calcification is pseudo-xanthoma elasticium.

7. The method according to claim 1, wherein said vitamin K is administered for a period of less than 3 months.

8. The method according to claim 7, wherein said vitamin K is administered for a period of less than 6 weeks.

9. The method according to claim 1, wherein said vitamin K is administered in an amount of 150-5000 μ

g/day.

10. The method according to claim 9, wherein said vitamin K is administered in an amount of 150-500 μ

g/day.

11. The method according to claim 1, wherein said vitamin K is administered in an amount of 70-14000 μ

g/week.

12. The method according to claim 10, wherein said vitamin K is administered in an amount of 350-7000 μ

g/week.

13. The method according to claim 1, wherein said vitamin K is administered in a pharmaceutical or nutritional formulation in a dosage form selected from the group consisting of a tablet, capsule, powder, soft gel, gummy, spray, beverage, food, syrup, and intravenous feed.

14. The method according to claim 13, wherein the pharmaceutical or nutritional formulation further comprises at least one additional pharmaceutically active component.

15. The method according to claim 14, wherein said at least one additional pharmaceutically active component is selected from the group consisting of anticoagulants, antithrombotics, fibrinolytics, antihypertensives, diuretics, antianginals, hypolipidaemic agents, beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors, cardiac glycosides, phosphodiesterase inhibitors, antiarrhythmics, and calcium antagonists.

16. The method according to claim 13, wherein the pharmaceutical or nutritional formulation further comprises at least one additional compound selected from the group consisting of polyphenols, vitamin C, vitamin E, L-Arginine, phytosterol, antihypertensive peptide, soluble fiber, omega-3 fatty acid(s), omega-6 fatty acid(s), omega-9 fatty acid(s), carnitine, taurine, coenzyme Q10, creatine, folic acid, folates, magnesium, potassium, vitamin B6, vitamin B12;

and vitamin D.

17. The method according to claim 16, wherein the formulation further comprises vitamin D.

18. The method according to claim 17, wherein the vitamin D is vitamin D3.

19. The method according to claim 1, wherein the daily dosage of vitamin K is from 0.03 to 10 mg/kg body weight.

20. A method of reversing calcification of blood vessels in a mammal suffering from vascular calcification, comprising administering to the mammal an effective amount of vitamin K to reverse calcification of the blood vessel within a period of 2-20 weeks, wherein reversing calcification of a blood vessel includes the removal of preexisting calcium deposits in the blood vessel, on the blood vessel, or a combination thereof.

21. The method according to claim 20, wherein said vascular calcification is a result of Stage 3 CKD, Stage 4 CKD, Stage 5 CKD, and/or hemodialysis.

22. A kit comprising 2-20 weeks of an initial treatment dose of vitamin K and 1 week-36 months of a lower maintenance dose of vitamin K.

23. A method of increasing endothelial nitric oxide production in a subject comprising administering to the subject an effective amount of vitamin K2 for a period of less than 6 months.

24. The method of claim 23, wherein the subject suffers from hypercholesterolemia with atherosclerotic plaques or hypercholesterolemia without atherosclerotic plaques.

25. The method of claim 24, wherein the subject suffers from hypercholesterolemia without atherosclerotic plaques.

26. The method of claim 23, wherein said vitamin K is menaquinone-7.

27. The method of claim 25, wherein said vitamin K is administered in an amount of 180-360 μ

g/day.