STATIN AND OMEGA-3 FATTY ACIDS FOR LIPID THERAPY

• US 20070191467A1
• Filed: 04/30/2007
• Published: 08/16/2007
• Est. Priority Date: 12/06/2004
• Status: Abandoned Application

• Current Assignee: Pronova Biocare As (Andresen Family), Reliant Pharmaceuticals Incorporated (GlaxoSmithKline PLC)
• Original Assignee: Reliant Pharmaceuticals Incorporated (GlaxoSmithKline PLC)
• Inventors: Bobotas, George, Vik, Hogne, Bodd, Egil, Rongen, Roelof
• Application Number:
  US11/742,292
• Publication Number:
  US 20070191467A1
• Time in Patent Office: Days
• US Class Current: 514/423
• 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 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/22 of acyclic acids, e.g. pravastatin
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 31/351 not condensed with another ring
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• 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

Abstract

A method of lipid therapy, comprising providing a subject group having a baseline triglyceride level of 200 to 499 mg/dl and being at or near its low-density lipoprotein cholesterol (LDL-C) level goal, and reducing the triglyceride level and the non-high-density lipoprotein cholesterol (non-HDL-C) level of the subject group as compared to treatment with a 3-hydroxy-3-methyl glutaryl coenzyme A (HMG CoA) inhibitor alone, by administering to the subject group an effective amount of an HMG CoA inhibitor and a composition comprising omega-3 fatty acids.

Claims

1. A method of lipid therapy, comprising

providing a subject group having a baseline triglyceride level of 200 to 499 mg/dl and being at or near its low-density lipoprotein cholesterol (LDL-C) treatment goal, and

reducing the triglyceride level and the non-high-density lipoprotein cholesterol (non-HDL-C) level of the subject group as compared to treatment with a 3-hydroxy-3-methyl glutaryl coenzyme A (HMG CoA) inhibitor alone, by administering to the subject group an effective amount of an HMG CoA inhibitor and a composition comprising omega-3 fatty acids.

2. The method of claim 1, wherein the subject group was receiving HMG CoA inhibitor therapy prior to said method.

3. The method of claim 1, wherein the omega-3 fatty acids are administered in an amount up to 4 g/day.

4. The method of claim 1, wherein the omega-3 fatty acids are present in a concentration of at least 40% by weight as compared to the total fatty acid content of the composition.

5. The method of claim 1, wherein the omega-3 fatty acids are present in a concentration of at least 80% by weight as compared to the total fatty acid content of the composition.

6. The method of claim 1, wherein the omega-3 fatty acids comprise about 40% to about 55% by weight of EPA as compared to the total fatty acid content of the composition.

7. The method of claim 1, wherein the omega-3 fatty acids comprise about 30% to about 60% by weight of DHA as compared to the total fatty acid content of the composition.

8. The method of claim 1, wherein the omega-3 fatty acids comprise omega-3 polyunsaturated, long-chain fatty acids, esters of omega-3 fatty acids with glycerol, esters of omega-3 fatty acids and a primary, secondary or tertiary alcohol, or mixtures thereof.

9. The method of claim 1, wherein the omega-3 fatty acids comprise EPA and DHA in a ratio of EPA:

DHA from 2;

1 to 1;

2.

10. The method of claim 1, wherein the HMG CoA inhibitor is selected from the group consisting of pitavastatin, atorvastatin, rosuvastatin, fluvastatin, lovastatin, pravastatin and simvastatin.

11. The method of claim 1, further comprising reducing at least one additional level of the subject group independently selected from the group consisting of the total cholesterol (TC) level, the apolipoprotein-B (Apo-B) level, and the very low-density lipoprotein cholesterol (VLDL-C) level, as compared to treatment with the HMG CoA inhibitor alone.

12. The method of claim 1, further comprising reducing the TC level, as compared to treatment with the HMG CoA inhibitor alone.

13. The method of claim 1, further comprising reducing the Apo-B level, as compared to treatment with the HMG CoA inhibitor alone.

14. The method of claim 1, further comprising reducing the VLDL-C level, as compared to treatment with the HMG CoA inhibitor alone.

15. The method of claim 1, further comprising increasing the high-density lipoprotein cholesterol (HDL-C) level, as compared to treatment with the HMG CoA inhibitor alone.

16. The method of claim 1, wherein the triglyceride level and the non-HDL-C level are reduced without increasing LDL-C level, as compared to treatment with the HMG CoA inhibitor alone.

17. The method of claim 1, wherein the method is first-line therapy for treatment of subjects with at least one condition or disease independently selected from the group consisting of hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease (CHD), vascular disease, atherosclerotic disease and related conditions.

18. The method of claim 1, wherein the method is second-line therapy for treatment of subjects with at least one condition or disease independently selected from the group consisting of hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease (CHD), vascular disease, atherosclerotic disease and related conditions.

19. The method of claim 1, wherein the method is first-line therapy for the prevention or reduction of cardiovascular or vascular events.

20. The method of claim 1, wherein the method is second-line therapy for the prevention or reduction of cardiovascular or vascular events.