AU2004216856A1 - Use of omega-3-fatty acids in the treatment of diabetic patients - Google Patents
Use of omega-3-fatty acids in the treatment of diabetic patients Download PDFInfo
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- AU2004216856A1 AU2004216856A1 AU2004216856A AU2004216856A AU2004216856A1 AU 2004216856 A1 AU2004216856 A1 AU 2004216856A1 AU 2004216856 A AU2004216856 A AU 2004216856A AU 2004216856 A AU2004216856 A AU 2004216856A AU 2004216856 A1 AU2004216856 A1 AU 2004216856A1
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- diabetes
- medicament
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- 206010012601 diabetes mellitus Diseases 0.000 title claims description 60
- 238000011282 treatment Methods 0.000 title claims description 17
- 235000020660 omega-3 fatty acid Nutrition 0.000 title description 2
- 229940012843 omega-3 fatty acid Drugs 0.000 title description 2
- 239000006014 omega-3 oil Substances 0.000 title description 2
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- JAZBEHYOTPTENJ-JLNKQSITSA-N all-cis-5,8,11,14,17-icosapentaenoic acid Chemical compound CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O JAZBEHYOTPTENJ-JLNKQSITSA-N 0.000 claims description 58
- 235000020669 docosahexaenoic acid Nutrition 0.000 claims description 56
- JAZBEHYOTPTENJ-UHFFFAOYSA-N eicosapentaenoic acid Natural products CCC=CCC=CCC=CCC=CCC=CCCCC(O)=O JAZBEHYOTPTENJ-UHFFFAOYSA-N 0.000 claims description 36
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- SSQPWTVBQMWLSZ-AAQCHOMXSA-N ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate Chemical compound CCOC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CC SSQPWTVBQMWLSZ-AAQCHOMXSA-N 0.000 claims description 7
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- DVSZKTAMJJTWFG-SKCDLICFSA-N (2e,4e,6e,8e,10e,12e)-docosa-2,4,6,8,10,12-hexaenoic acid Chemical compound CCCCCCCCC\C=C\C=C\C=C\C=C\C=C\C=C\C(O)=O DVSZKTAMJJTWFG-SKCDLICFSA-N 0.000 description 2
- GZJLLYHBALOKEX-UHFFFAOYSA-N 6-Ketone, O18-Me-Ussuriedine Natural products CC=CCC=CCC=CCC=CCC=CCC=CCCCC(O)=O GZJLLYHBALOKEX-UHFFFAOYSA-N 0.000 description 2
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- 108010069201 VLDL Cholesterol Proteins 0.000 description 2
- YZXBAPSDXZZRGB-DOFZRALJSA-N arachidonic acid Chemical compound CCCCC\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O YZXBAPSDXZZRGB-DOFZRALJSA-N 0.000 description 2
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- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
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- 208000011775 arteriosclerosis disease Diseases 0.000 description 1
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- 150000001875 compounds Chemical class 0.000 description 1
- 208000026758 coronary atherosclerosis Diseases 0.000 description 1
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
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- 235000005911 diet Nutrition 0.000 description 1
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- XEYBRNLFEZDVAW-ARSRFYASSA-N dinoprostone Chemical compound CCCCC[C@H](O)\C=C\[C@H]1[C@H](O)CC(=O)[C@@H]1C\C=C/CCCC(O)=O XEYBRNLFEZDVAW-ARSRFYASSA-N 0.000 description 1
- 229960002986 dinoprostone Drugs 0.000 description 1
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- 229940079593 drug Drugs 0.000 description 1
- ZUBDGKVDJUIMQQ-UBFCDGJISA-N endothelin-1 Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(O)=O)NC(=O)[C@H]1NC(=O)[C@H](CC=2C=CC=CC=2)NC(=O)[C@@H](CC=2C=CC(O)=CC=2)NC(=O)[C@H](C(C)C)NC(=O)[C@H]2CSSC[C@@H](C(N[C@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N2)=O)NC(=O)[C@@H](CO)NC(=O)[C@H](N)CSSC1)C1=CNC=N1 ZUBDGKVDJUIMQQ-UBFCDGJISA-N 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 235000021323 fish oil Nutrition 0.000 description 1
- 229940013317 fish oils Drugs 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 230000014509 gene expression Effects 0.000 description 1
- 230000004153 glucose metabolism Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000005087 mononuclear cell Anatomy 0.000 description 1
- 229940071462 oralone Drugs 0.000 description 1
- 230000037324 pain perception Effects 0.000 description 1
- 108010017843 platelet-derived growth factor A Proteins 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 235000020777 polyunsaturated fatty acids Nutrition 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 201000009104 prediabetes syndrome Diseases 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- ANOKPYOFAYATSS-UHFFFAOYSA-N propyl 4-oxocyclohexa-1,5-diene-1-carboxylate;sodium Chemical compound [Na].CCCOC(=O)C1=CCC(=O)C=C1 ANOKPYOFAYATSS-UHFFFAOYSA-N 0.000 description 1
- XEYBRNLFEZDVAW-UHFFFAOYSA-N prostaglandin E2 Natural products CCCCCC(O)C=CC1C(O)CC(=O)C1CC=CCCCC(O)=O XEYBRNLFEZDVAW-UHFFFAOYSA-N 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229960000984 tocofersolan Drugs 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 239000002076 α-tocopherol Substances 0.000 description 1
- 235000004835 α-tocopherol Nutrition 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Diabetes (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Emergency Medicine (AREA)
- Epidemiology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
WO 2004/078166 PCTIEP2004/050238 Use of Omega-3-Fatty Acids in the Treatment of Diabetic Patients DESCRIPTION This invention concerns the use of a pharmaceutical composition containing essential fatty acid ethyl enters originating from fish oils, in particular as a high concentration mixture of ethyl esters of (20:5w 3) eicosapentaenoic acid (EPA) and (22:6w 3) docosahexaenoic acid (DHA) in patients who suffer from diabetes. It is well known that certain essential fatty acids contained in fish oil have a therapeutic effect in the prevention and treatment of cardiovascular disorders, such as in the treat ment of hypertension, thrombosis, hypercholesterolemia, arteriosclerosis, cerebral in farction, prevention of sudden death in post myocardial infarction patients, improve ment of endothelial function and hyperlipedemias. US Patents US 5,502,077, US 5,656,667 and US 5,698,594 can be quoted as exam ples. The prevention of cardiovascular events, especially of mortality in patients who have survived the hospitalization phase of acute myocardial infarction (AMI) is de scribed in the international patent application WO 00/48592. The above prior art in particular provide knowledge about the utility of fatty acids be longing to the W-3 family, more specifically (20:5W 3) eicosapentaenoic acid (EPA) and (22:6W 3) docosahexaenoic acid (DHA), in treating the above-mentioned disorders. The fatty acid EPA, being a precursor of PG13 and TxA3, exerts a preventing platelet aggregation effect and an antithombotic effect that can be ascribed to inhibition of cyclooxygenase (similar effect to that of aspirin) and/or to competition with arachidonic acid for this enzyme, with consequent reduction in the sythesis of PGE2 and TxA2, which are well known platelet aggregating agents. On the other hand the fatty acid DHA is the most important component of cerebral lip ids in man and furthermore, being a structural component of the platelet cell it inter- WO 2004/078166 PCT/EP2004/050238 2 venes indirectly in increasing platelet fluidity, thus playing an important role in an tithombotic activity. The international patent application WO 89/11521, whose description is herein incorpo rated by reference, describes in particular an industrial process for extracting mixtures with a high content in poly-unsaturated acids, including EPA and DHA and their ethyl esters, from animal and/or vegetable oils. Mixtures of fatty acids, especially EPA/DHA, obtained according to WO 89/11521, are reported to be particularly useful in the treatment of cardiovascular diseases. However, current methods of treatment used in human therapy have been shown to be insufficient in patients who have a diabetes mellitus, in particular in those patients in whom it is desired to also prevent cardiovascular events. It is well known that patients with diabetes, in particular with diabetes mellitus, are at a substantially increased risk of cardiovascular events and death. Therefore, there still is a substantial need for improved and effective treatments with drugs, in particular for preventing these recurrences. Object of this invention, therefore, is to provide such improved and effective treatment of diabetic patients. This invention, therefore, suggests the novel use of essential fatty acids with a high content in EPA-ethyl ester or DHA-ethyl ester or a high concentration mixture thereof, in the preparation of a medicament useful for the treatment of patients suffering from diabetes. In particular, the invention is directed to preventing cardiovascular events in patients who have diabetes mellitus. For ease of description "EPA-ethyl ester" and "DHA-ethyl ester" will be also quoted here as "EPA" and "DHA". In particular this invention pertains to the use of essential fatty acids containing a mix ture of eicosapentanoic acid ethyl ester (EPA) and docosahexaenoic acid ethyl ester (DHA) in the preparation of a medicament useful for the treatment of patients suffering from diabetes, preferably for preventing cardiovascular events in patients who have diabetes, where the content in EPA and DHA in such mixture is greater than 25% b.w. An essential fatty acid with high content in EPA or DHA, according to the present in vention, preferably contains more than 25% by weight (b.w.), in particular from about WO 2004/078166 PCT/EP2004/050238 3 60 to about 100% of such ester. These compounds can be obtained by known meth ods. In an essential fatty acid with a high concentration mixture of EPA and DHA, preferably such mixture has a content in EPA and DHA greater than 25% by weight, in particular from about 30 to about 100% by weight, preferably about 85% by weight. In the EPA/DHA mixture, EPA preferably is present in a percentage from about 40 to 60% by weight and DHA, preferably in a percentage from about 25 to about 45-50%. In any case the preferred EPA/DHA ratio in such EPA/DHA mixture is about 0.9/1.5. PHARMACOLOGY Diabetes mellitus has become an increasingly prevalent disease worldwide. The preva lence of diabetes is increasing rapidly and the number of individuals with type 11 diabe tes (80-90% of all diabetic people) is depicted to reach 300 million in the year 2025, accounting for 5.4% of the global population. Furthermore, cardiovascular events are important contributors to morbidity and mortality in patients with diabetic disease. The risk of death from cardiovascular disease is in patients with diabetes two to six times that among persons without diabetes. Currently, over 50% of diabetic patients die from coronary heart disease. In contrast to non-diabetic people, coronary heart mortality has not declined in diabetic people. Type |1 diabetes eliminates the protective advantage of female sex against coronary heart disease mortality. The prognosis after a coronary heart disease event is poorer in diabetic people than in non-diabetic people. Within 1 year after an acute myocardial infarction, 44.2% of type || diabetic men and 36.9% of type 11 diabetic women die. All manifestations of coronary heart disease are at least twice as common in patients with diabetes as in non diabetic individuals. Moreover, recently close interrelations be tween diabetes and cardiovascular disease, not at least with coronary artery disease, were elucidated. It has been demonstrated in a number of studies that 28% of patients with known coronary artery disease have diabetes, and as many as 70% of patients with acute coronary syndromes have abnormal glucose metabolism, either in the form of diabetes or impaired glucose tolerance. Major risk factors for coronary heart disease in patients with diabetes are: 1. unfavorable lipoprotein profile, characterized by increased serum triglycerides; 2. elevated blood pressure; WO 2004/078166 PCT/EP2004/050238 4 3. predisposition to formation of thrombosis, including the following manifestations: high concentrations of plasminogen activator-I and cytokines; 4. impairment of endothelin-dependent vasodilatation; 5. cardiac autonomic impairment leading to decreased ischaemic pain perception, higher heart rate and decresed heart rate variability, which in turn increases the risk for sudden death. The efficacy of the treatment, according to the present invention, is proven by ample pre-clinical and clinical evidence: 1. EPA plus DHA induces a reduction in the levels of triglycerides and of very-low density lipoprotein cholesterol (VLDL) in patients with hypertriglyceremia; 2. EPA plus DHA does lower blood pressure in patients with hypertension; 3. Dietary EPA and DHA down-regulate gene expression of platelet-derived growth factor-A and of platelet-derived growth factor-B in human mononuclear cells; 4. Supplementation with EPA plus DHA mitigates the course of coronary athero sclerosis in patients with coronary heart disease; 5. EPA and DHA improves endothelial function in heart transplant recipients. 6. Experimental studies have shown that EPA and DHA are antiarrhythmic in sev eral animal models, probably due to specific modulation of ion currents; 7. EPA and DHA increases heart rate variability in healthy volunteers and in survi vors of a myocardial infarction; 8. EPA plus DHA decreases the incidence of sudden death in survivors of a myo cardial infarction. The above mentioned evidence of reducing risk factors shows that the present inven tion provides a new and valuable therapeutic tool for treating diabetic patients, and in particular for preventing cardiovascular events in diabetic patients. Accordingly, this invention also provides a method for treating diabetic patients, pref erably patients with diabetes mellitus and in particular for preventing cardiovascular events in diabetic patients, preferably in patients with diabetes mellitus, comprising administering to such patient a therapeutically effective amount of a medicament con taining essential fatty acids with a high content in EPA-ethyl ester or DHA-ethyl ester or a high concentration mixture thereof. The essential fatty acids, according to the invention, can either have a high content, for instance more than 25% b.w., in EPA or DHA or in a mixture thereof. However, EPA WO 2004/078166 PCT/EP2004/050238 5 and DHA-ethyl ester are preferably present as a mixture thereof with a content in EPA and DHA higher than 25% b.w., in particular from about 30 to about 100% b.w., pref erably about 85% b.w. Based on the available evidence, according to a preferred aspect of the invention, the dosage of an essential fatty acid containing an EPA and DHA mixture with 85% b.w. titer for oral administration to a patient may vary from about 0.7g to about 6g daily, preferably about 1g daily. This amount of product as EPA and DHA mixture (or amount of EPA alone or DHA alone) may be administered in several divided doses throughout the day or preferably in a single administration, in order to achieve the desired hematic level. Obviously it is at the discretion of the physician to adjust the quantity of product to be administered according to the age, weight and general conditions of the patient. The medicament, e.g. in the form of a pharmaceutical composition, according to this invention can be prepared according to known methods in the art. The preferred route of administration is the oral one, however leaving alternative routes of administration, such as the parenteral route, to the discretion of the physician. The preferred variants of the present invention are furthermore defined in the sub claims. The following examples illustrate preferred formulations for oral administration, but do not intend to limit the invention in any way. Gelatin capsules According to known pharmaceutical techniques, capsules having the composition be low and containing 1g of active ingredient (EPA and DHA, 85% titer) per capsule are prepared.
WO 2004/078166 PCT/EP2004/050238 6 Formulation 1 EPA-ethyl ester 525 mg / capsule DHA-ethyl ester 315 mg / capsule d-alpha tocopherol 41U / capsule gelatin 246 mg I capsule glycerol 118 mg / capsule red iron oxide 2.27 mg / capsule yellow iron oxide 1.27 mg I capsule Formulation 2 Ethyl esters of polyunsaturated fatty acids 1000 mg with content in ethyl esters of w-3 poly unsaturated esters (eicosapentaenoic EPA, docosahexaenoic DHA) 850 mg d-1-a-tocopherol 0.3 mg gelatin succinate 233 mg glycerol 67 mg sodium p-oxybenzoate 1.09 mg sodium propyl p-oxobenzoate 0.54 mg
Claims (29)
1. Use of essential fatty acids containing a mixture of eicosapentanoic acid ethyl ester (EPA) and docosahexaenoic acid ethyl ester (DHA) in the preparation of a medicament useful for the treatment of patients suffering from diabetes, preferably for preventing cardiovascular events in patients who have diabetes, where the content in EPA and DHA in such mixture is greater than 25% b.w.
2. Use according to claim 1, wherein the medicament is useful for prevent ing cardiovascular events in a patient who has diabetes mellitus.
3. Use according to claim I or 2, wherein the content in EPA and DHA in such mixture is from about 30 to about 100% b.w.
4. Use according to claim I or 2, wherein the content in EPA and DHA in such mixture is about 85% b.w.
5. Use according to anyone of claims I to 4, wherein the medicament is for oral administration.
6. Use according to claim 4, wherein the medicament is for oral administra tion, at a dosage from about 0.7 g to about 6 g daily.
7. Use according to claim 6, wherein the EPA and DHA ration in the EPA and DHA mixture is about 0.911.5.
8. Use of essential fatty acids containing eicosapentaenoic acid ethyl ester (EPA) or docosahexaenoic acid ethyl ester (DHA) in the preparation of a medicament useful for the treatment of patients suffering from diabetes, preferably for preventing cardiovascular events in patients who have diabetes, wherein the EPA and DHA con tent is greater than 25% b.w.
9. Use according to claim 8, wherein the medicament is useful for prevent ing cardiovascular events in a patient who has diabetes mellitus.
10. Use according to claim 8 or 9, wherein the EPA or DHA content is from about 60 to about 100% b.w. WO 2004/078166 PCT/EP2004/050238 8
11. Use according to anyone of claims 8 to 10, wherein the medicament is for oral administration.
12. A method for the treatment of patients suffering from diabetes, preferably diabetes mellitus, in particular for preventing cardiovascular events in patients who have diabetes, preferably in a patient who has diabetes mellitus, comprising adminis tering to said patient a therapeutically effective amount of a medicament containing essential fatty acids containing a mixture of eicosapentaenoic acid ethyl ester (EPA) and docosahexaenoic acid ethyl ester (DHA) wherein the content in EPA and DHA in such mixture is greater than 25% b.w.
13. A method according to claim 12, wherein the content in EPA and DHA in such mixture is from about 30 to about 100% b.w.
14. A method according to claim 12, wherein the content in EPA and DHA in such mixture is about 85% b.w.
15. A method according to claim 12, 13 or 14, wherein the medicament is administered orally.
16. A method according to claim 14, wherein the medicament is administered orally at a dosage from about 0.7g to about 6 g daily.
17. A method according to claim 16, wherein the EPA I DHA ratio in the EPA and DHA mixture is about 0.9/1.5
18. A method for the treatment of patients suffering from diabetes, preferably diabetes mellitus, in particular for preventing cardiovascular events In patients who have diabetes, preferably in a patient who has diabetes mellitus, comprising adminis tering to said patient a therapeutically effective amount of a medicament containing essential fatty acids containing a mixture of eicosapentaenoic acid ethy ester (DPA) and docosahexaenoic acid ethyl elster (DHA), wherein the content in EPA and DHA in such mixture is greater than 25% b.w.
19. A method according to claim 18, wherein the content in EPA and DHA in such mixture is from about 30 to about 100% b.w. WO 2004/078166 PCT/EP2004/050238 9
20. A method according to claim 18, wherein the content in EPA and DHA in such mixture is about 85% b.w.
21. A method according to claim 18, 19 or 20, wherein the medicament is administered orally.
22. A method according to claim 20, wherein the medicament is administered orally at a dosage from about 0.7g to about 6 g daily.
23. A method according to claim 22, wherein the EPA / DHA ratio in the EPA and DHA mixture is about 0.9/1.5.
24. A method for the treatment of patients suffering from diabetes, preferably diabetes mellitus, in particular for preventing cardiovascular events in patients who have diabetes, preferably in a patient who has diabetes mellitus, comprising adminis tering to said patient a therapeutically effective amount of a medicament containing essential fatty acids with a content in eicosapentaencic acid ethyl ester (EPA) or in docosahexaenoic acid ethyl ester (DHA) greater than 25% b.w.
25. A method according to claim 24, wherein the contention EPA or DHA is form about 60 to about 100% b.w.
26. A method according to claim 24 or 25, wherein the medicament is administered orally.
27. A method for the treatment of patients suffering from diabetes, preferably diabetes mellitus, in particular for preventing cardiovascular events in patients who have diabetes, preferably in a patient who has diabetes mellitus, comprising adminis tering to said patient a therapeutically effective amount of a medicament containing essential fatty acids with a content in eicosapentaenoic acid ethyl ester (EPA) or doco sahexaenoic acid ethyl ester (DHA) greater than 25% b.w.
28. A method according to claim 27, wherein the content in EPA or DHA is from about 60 to about 100% b.w.
29. A method according to claim 27 or 28, wherein the medicament is administered orally.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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EP03004792 | 2003-03-05 | ||
EP03004792.2 | 2003-03-05 | ||
PCT/EP2004/050238 WO2004078166A2 (en) | 2003-03-05 | 2004-03-02 | Use of omega-3-fatty acids in the treatment of diabetic patients |
Publications (1)
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AU2004216856A1 true AU2004216856A1 (en) | 2004-09-16 |
Family
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AU2004216856A Abandoned AU2004216856A1 (en) | 2003-03-05 | 2004-03-02 | Use of omega-3-fatty acids in the treatment of diabetic patients |
Country Status (8)
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EP (1) | EP1603551A2 (en) |
JP (1) | JP2006519244A (en) |
CN (1) | CN1756545A (en) |
AU (1) | AU2004216856A1 (en) |
BR (1) | BRPI0408006A (en) |
CA (1) | CA2515328A1 (en) |
MX (1) | MXPA05009432A (en) |
WO (1) | WO2004078166A2 (en) |
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JP5134916B2 (en) * | 2005-07-08 | 2013-01-30 | 持田製薬株式会社 | Composition for preventing cardiovascular events |
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KR20090077081A (en) * | 2006-11-03 | 2009-07-14 | 프로노바 바이오파마 노르지 에이에스 | Fatty acid alcohols |
WO2010018856A1 (en) * | 2008-08-13 | 2010-02-18 | 持田製薬株式会社 | Prophylactic/ameliorating or therapeutic agent for cannabinoid receptor-related disease |
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US20140271841A1 (en) | 2013-03-15 | 2014-09-18 | Amarin Pharmaceuticals Ireland Limited | Pharmaceutical composition comprising eicosapentaenoic acid and derivatives thereof and a statin |
US10966968B2 (en) | 2013-06-06 | 2021-04-06 | Amarin Pharmaceuticals Ireland Limited | Co-administration of rosiglitazone and eicosapentaenoic acid or a derivative thereof |
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JPS60248610A (en) * | 1984-05-23 | 1985-12-09 | Nitsusui Seiyaku Kk | Preventive and remedy for complicated diabetes |
GB2218904A (en) * | 1988-05-27 | 1989-11-29 | Renafield Limited | Pharmaceutical composition based on high-concentration esters of docosahexaenoic acid |
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2004
- 2004-03-02 EP EP04737282A patent/EP1603551A2/en not_active Withdrawn
- 2004-03-02 CA CA002515328A patent/CA2515328A1/en not_active Abandoned
- 2004-03-02 JP JP2006505440A patent/JP2006519244A/en active Pending
- 2004-03-02 MX MXPA05009432A patent/MXPA05009432A/en unknown
- 2004-03-02 WO PCT/EP2004/050238 patent/WO2004078166A2/en not_active Application Discontinuation
- 2004-03-02 BR BRPI0408006-8A patent/BRPI0408006A/en not_active Application Discontinuation
- 2004-03-02 CN CNA2004800055600A patent/CN1756545A/en active Pending
- 2004-03-02 AU AU2004216856A patent/AU2004216856A1/en not_active Abandoned
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EP1603551A2 (en) | 2005-12-14 |
WO2004078166A3 (en) | 2004-10-28 |
CN1756545A (en) | 2006-04-05 |
BRPI0408006A (en) | 2006-02-14 |
CA2515328A1 (en) | 2004-09-16 |
WO2004078166A2 (en) | 2004-09-16 |
JP2006519244A (en) | 2006-08-24 |
MXPA05009432A (en) | 2005-11-23 |
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