Compositions for treating or preventing cardiovascular disease

• US 9,364,447 B2
• Filed: 06/03/2005
• Issued: 06/14/2016
• Est. Priority Date: 08/30/2002
• Status: Active Grant

• Current Assignee: Nattopharma R&D Limited
• Original Assignee: NattoPharma ASA (Lesaffre & Co. SA)
• Inventors: Vermeer, Cees
• Primary Examiner(s): Pak, John
• Assistant Examiner(s): Schlientz, Nathan W
• Application Number:
  US11/144,853
• Publication Number:
  US 20050261257A1
• Time in Patent Office: 4,029 Days
• US Class Current: 1/1
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/155 Vitamins A or D
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/1578 Calcium
• CPC Class Codes: A23V 2250/161 Magnesium
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/7106 Vitamin D3
• CPC Class Codes: A23V 2250/7142 Vitamin K1
• 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 31/12 Ketones
• CPC Class Codes: A61K 31/122 having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• 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 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• 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 9/12 Antihypertensives
• CPC Class Codes: A61P 9/14 : Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

Vitamin K is effective in counteracting cardiovascular disorders such as the reduction in arterial elasticity normally associated with the aging process. A pharmaceutical composition or nutritional formulation comprising vitamin K can be used to combat age-related stiffening of the arteries, and the consequences thereof, namely pulmonary congestion, hypertension, left ventricular hypertrophy, congestive (right sided) heart failure, left sided or left ventricular failure, chronic cardiac failure, angina pectoris, myocardial infarction, Mönckeberg'"'"'s sclerosis and stroke. In various embodiments, vitamin K can also be used to reduce or reverse calcification of a blood vessel in pre-existing cardiovascular disorders such as arteriosclerosis.

Claims

1. A method of treating or reducing the incidence of age-related stiffening of arteries in a mammal suffering from angina pectoris, hypertension, or a history of stroke and/or other cerebrovascular disorders, comprising

a) measuring degradation of elastic lamellae in the tunica media of said mammal'"'"'s aorta or common carotid artery, and

b) administering to the mammal an effective amount of vitamin K and vitamin D in a composition to treat or reduce the incidence of age-related stiffening of the arteries, wherein said vitamin K is administered in an amount between 10-1000 micrograms/day and said vitamin D is administered in an amount of 2 to 50 micrograms/day and the composition containing no vitamin E, wherein the age-related stiffening of arteries is not associated with arteriosclerosis.

2. A method according to claim 1, wherein the vitamin K is contained in a pharmaceutical or nutritional formulation.

3. A method according to claim 2, wherein the vitamin K is contained in a food or beverage product or a dietary supplement.

4. A method according to claim 1, wherein the age-related stiffening is of the tunica media of the aorta or common carotid artery.

5. A method according to claim 1, wherein the vitamin K comprises vitamin K₁ (phylloquinone), vitamin K₂, (menaquinone) or a combination thereof.

6. A method according to claim 1, wherein the vitamin D is vitamin D₃ (cholecalciferol).

7. A method according to claim 1, wherein the mammal is a human.

8. A method according to claim 1, wherein the mammal is a postmenopausal woman.

9. A method according to claim 1, wherein the composition is to be administered over a period of at least 12 months.

10. A method according to claim 1, wherein said arteries are the common carotid arteries.

11. A method according to claim 1, wherein the method is used for treating age-related stiffening of arteries and comprises administering vitamin K together with vitamin D, and one or more additional components selected from the group consisting of:

polyphenols, vitamin C, L-arginine, phytosterols, antihypertensive peptides, soluble fibers, carnitine, taurine, coenzyme Q10, creatine, folic acid, folates, magnesium, potassium, vitamin B6, and vitamin B12.

12. The method according to claim 11, wherein soluble fibers are guar or pectin.

13. A method according to claim 1, wherein the compositon is to be administered over a period of at least 36 months.

14. The method according to claim 1, wherein degradation of said elastic lamellae in the tunica media of said mammal'"'"'s aorta or common carotid artery is determined using ultrasound.