EP1603551A2 - 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

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Withdrawn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)
French (fr)
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/en
Publication of EP1603551A2 publication Critical patent/EP1603551A2/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic 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
    • A61K31/202Carboxylic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs 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)
  • 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)
EP04737282A 2003-03-05 2004-03-02 Use of omega-3-fatty acids in the treatment of diabetic patients Withdrawn EP1603551A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04737282A EP1603551A2 (en) 2003-03-05 2004-03-02 Use of omega-3-fatty acids in the treatment of diabetic patients

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP03004792 2003-03-05
EP03004792 2003-03-05
EP04737282A EP1603551A2 (en) 2003-03-05 2004-03-02 Use of omega-3-fatty acids in the treatment of diabetic patients
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)

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

Family

ID=32946844

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04737282A Withdrawn EP1603551A2 (en) 2003-03-05 2004-03-02 Use of omega-3-fatty acids in the treatment of diabetic patients

Country Status (8)

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

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CN101213281B (zh) * 2005-05-04 2013-03-13 普罗诺瓦生物医药挪威公司 新的dha衍生物及其作为药物的用途
JP5134916B2 (ja) * 2005-07-08 2013-01-30 持田製薬株式会社 心血管イベント発症予防用組成物
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BRPI0717972A2 (pt) * 2006-11-01 2013-11-12 Pronova Biopharma Norge As Lipídeos de ômega-3 alfa-substituídos que são ativadores ou moduladores do receptor ativado por proliferadores de peroxissoma (ppar)
BRPI0718393A2 (pt) * 2006-11-03 2013-11-26 Pronova Biopharma Norge As Álcoois de ácido graxo
JPWO2010018856A1 (ja) * 2008-08-13 2012-01-26 持田製薬株式会社 カンナビノイド受容体関連疾患の予防/改善または治療剤
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KR102012111B1 (ko) 2009-06-15 2019-08-19 아마린 파마, 인크. 병용 스타틴 요법을 받는 대상체에서 ldl-c 수준을 상승시키지 않으면서 트리글리세리드를 저하시키기 위한 조성물 및 방법
FR2949063B1 (fr) * 2009-08-11 2011-09-30 Pf Medicament Composition pharmaceutique comprenant un ester de dha destinee a etre administree par voie parenterale
SG10201405994UA (en) 2009-09-23 2014-10-30 Amarin Pharmaceuticals Ie Ltd Pharmaceutical Composition Comprising Omega-3 Fatty Acid And Hydroxy-derivative Of A Statin And Methods Of Using Same
CN103338762B (zh) * 2010-11-09 2015-03-25 持田制药株式会社 血糖值上升抑制剂
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
NZ712068A (en) 2010-11-29 2017-03-31 Amarin Pharmaceuticals Ie Ltd 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
EP2775837A4 (en) 2011-11-07 2015-10-28 Amarin Pharmaceuticals Ie Ltd METHODS OF TREATING HYPERTRIGLYCERIDEMIA
WO2013103958A1 (en) 2012-01-06 2013-07-11 Amarin Pharmaceuticals Ireland Limited Compositions and methods for lowering levels of high-sensitivity (hs-crp) in a subject
SG11201408769QA (en) 2012-06-29 2015-01-29 Amarin Pharmaceuticals Ie Ltd Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
US20150265566A1 (en) 2012-11-06 2015-09-24 Amarin Pharmaceuticals Ireland Limited Compositions and Methods for Lowering Triglycerides without Raising LDL-C Levels in a Subject on Concomitant Statin Therapy
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US9662307B2 (en) 2013-02-19 2017-05-30 The Regents Of The University Of Colorado Compositions comprising eicosapentaenoic acid and a hydroxyl compound and methods of use thereof
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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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Also Published As

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

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