EP1603551A2 - Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques - Google Patents

Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques

Info

Publication number
EP1603551A2
EP1603551A2 EP04737282A EP04737282A EP1603551A2 EP 1603551 A2 EP1603551 A2 EP 1603551A2 EP 04737282 A EP04737282 A EP 04737282A EP 04737282 A EP04737282 A EP 04737282A EP 1603551 A2 EP1603551 A2 EP 1603551A2
Authority
EP
European Patent Office
Prior art keywords
dha
epa
diabetes
medicament
mixture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04737282A
Other languages
German (de)
English (en)
Inventor
Rainer Oelze
Cees-Nico Verboom
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Products GmbH
Original Assignee
Solvay Pharmaceuticals GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Solvay Pharmaceuticals GmbH filed Critical Solvay Pharmaceuticals GmbH
Priority to EP04737282A priority Critical patent/EP1603551A2/fr
Publication of EP1603551A2 publication Critical patent/EP1603551A2/fr
Withdrawn legal-status Critical Current

Links

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

Definitions

  • This invention concerns the use of a pharmaceutical composition containing essential fatty acid ethyl esters originating from fish oils, in particular as a high concentration mixture of ethyl esters of (20:5 ⁇ 3) eicosapentaenoic acid (EPA) and (22:6 ⁇ 3) docosahexaenoic acid (DHA) in patients who suffer from diabetes.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • the above prior art in particular provide knowledge about the utility of fatty acids belonging to the ⁇ -3 family, more specifically (20:501 3) eicosapentaenoic acid (EPA) and (22:610 3) docosahexaenoic acid (DHA), in treating the above-mentioned disorders.
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • 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- venes indirectly in increasing platelet fluidity, thus playing an important role in antithombotic activity.
  • This invention 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.
  • the invention is directed to preventing cardiovascular events in patients who have diabetes mellitus.
  • this invention pertains to the 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.
  • EPA eicosapentanoic acid ethyl ester
  • DHA docosahexaenoic acid ethyl ester
  • An essential fatty acid with high content in EPA or DHA, according to the present invention preferably contains more than 25% by weight (b.w.), in particular from about 60 to about 100% of such ester.
  • b.w. 25% by weight
  • These compounds can be obtained by known methods.
  • 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.
  • 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.
  • Diabetes mellitus has become an increasingly prevalent disease worldwide.
  • the prevalence of diabetes is increasing rapidly and the number of individuals with type II diabetes (80-90% of all diabetic people) is depicted to reach 300 million in the year 2025, accounting for 5.4% of the global population.
  • 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.
  • Type II diabetes eliminates the protective advantage of female sex against coronary heart disease mortality.
  • EPA plus DHA induces a reduction in the levels of triglycerides and of very-low density lipoprotein cholesterol (VLDL) in patients with hypertriglyceremia;
  • VLDL very-low density lipoprotein cholesterol
  • the present invention provides a new and valuable therapeutic tool for treating diabetic patients, and in particular for preventing cardiovascular events in diabetic patients.
  • this invention also provides a method for treating diabetic patients, preferably 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 containing 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 can either have a high content, for instance more than 25% b.w., in EPA or DHA or in a mixture thereof.
  • EPA 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., preferably about 85% b.w.
  • 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 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.
  • capsules having the composition below and containing 1g of active ingredient (EPA and DHA, 85% titer) per capsule are prepared.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Diabetes (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne l'utilisation d'acides gras essentiels à teneur élevée en ester d'éthyle d'acide eicosapentanoïque (EPA) ou un ester d'éthyle d'acide docosahexanoïque (DHA), lesdits acides gras étant utilisés pour prévenir des événements cardio-vasculaires chez des patients souffrant de diabète sucré.
EP04737282A 2003-03-05 2004-03-02 Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques Withdrawn EP1603551A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04737282A EP1603551A2 (fr) 2003-03-05 2004-03-02 Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP03004792 2003-03-05
EP03004792 2003-03-05
PCT/EP2004/050238 WO2004078166A2 (fr) 2003-03-05 2004-03-02 Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques
EP04737282A EP1603551A2 (fr) 2003-03-05 2004-03-02 Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques

Publications (1)

Publication Number Publication Date
EP1603551A2 true EP1603551A2 (fr) 2005-12-14

Family

ID=32946844

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04737282A Withdrawn EP1603551A2 (fr) 2003-03-05 2004-03-02 Utilisation d'acides gras omega-3 dans le traitement de personnes diabetiques

Country Status (8)

Country Link
EP (1) EP1603551A2 (fr)
JP (1) JP2006519244A (fr)
CN (1) CN1756545A (fr)
AU (1) AU2004216856A1 (fr)
BR (1) BRPI0408006A (fr)
CA (1) CA2515328A1 (fr)
MX (1) MXPA05009432A (fr)
WO (1) WO2004078166A2 (fr)

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EP3278665B1 (fr) 2009-04-29 2020-09-09 Amarin Pharmaceuticals Ireland Limited Composition pharmaceutique stable et procédés d'utilisation associés
CN108096209A (zh) 2009-06-15 2018-06-01 阿马里纳制药公司 在相伴他汀类疗法的对象中降低甘油三酯、没有增加ldl-c水平的组合物和方法
FR2949063B1 (fr) * 2009-08-11 2011-09-30 Pf Medicament Composition pharmaceutique comprenant un ester de dha destinee a etre administree par voie parenterale
KR101798670B1 (ko) 2009-09-23 2017-11-16 아마린 코포레이션 피엘씨 오메가-3 지방산 및 스타틴의 히드록시-유도체를 포함하는 제약 조성물 및 그의 사용 방법
US20130303614A1 (en) * 2010-11-09 2013-11-14 Nippon Suisan Kaisha, Ltd. Agent for inhibiting elevation in blood glucose level
NZ611606A (en) 2010-11-29 2015-10-30 Amarin Pharmaceuticals Ie Ltd Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity
US11712429B2 (en) 2010-11-29 2023-08-01 Amarin Pharmaceuticals Ireland Limited Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity
US11291643B2 (en) 2011-11-07 2022-04-05 Amarin Pharmaceuticals Ireland Limited Methods of treating hypertriglyceridemia
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Also Published As

Publication number Publication date
JP2006519244A (ja) 2006-08-24
WO2004078166A3 (fr) 2004-10-28
CN1756545A (zh) 2006-04-05
BRPI0408006A (pt) 2006-02-14
CA2515328A1 (fr) 2004-09-16
MXPA05009432A (es) 2005-11-23
AU2004216856A1 (en) 2004-09-16
WO2004078166A2 (fr) 2004-09-16

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