JP2007523049A - 高脂血症治療剤 - Google Patents
高脂血症治療剤 Download PDFInfo
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- JP2007523049A JP2007523049A JP2006525561A JP2006525561A JP2007523049A JP 2007523049 A JP2007523049 A JP 2007523049A JP 2006525561 A JP2006525561 A JP 2006525561A JP 2006525561 A JP2006525561 A JP 2006525561A JP 2007523049 A JP2007523049 A JP 2007523049A
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- hyperlipidemia
- therapeutic agent
- pitavastatin
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
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- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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- 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
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Medicinal Chemistry (AREA)
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- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Pyrane Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
【解決手段】本発明によれば、血中のコレステロール及びトリグリセリドを低下させる効果に優れたIIb型及びIV型高脂血症治療剤を提供することができる。
【選択図】なし
Description
高脂血症の治療には種々の薬剤が用いられ、現在、プラバスタチン、シンバスタチン、フルバスタチン、アトルバスタチン等のHMG−CoAリダクターゼ阻害剤が治療剤の中心をなしている。ピタバスタチン類は強いHMG−CoAリダクターゼ阻害作用を有し、血中コレステロール低下剤として有用であることが知られている(特許文献1〜3)。
尚、上記イコサペント酸又はそのエステル誘導体の純度は、特に限定されないが、投与量が少なくてすむという点から高純度のものが好ましい。
Wistar系雄性ラット(日本医科学実験動物(株))6週齢を供試した。実験期間を通じて、明暗サイクル(室内光による明るい期間:午前7時〜午後7時)、温度23±3℃、湿度55±15%に維持された飼育室で飼育し、固形飼料(CE−2;日本クレア(株))及び水道水を自由摂取させた。
ピタバスタチンカルシウムはカルボキシメチルセルロースナトリウム(岩井化学薬品(株))の0.5%質量水溶液に懸濁し、投与量が2mL/kgになるように調製した。ピタバスタチンカルシウムは9.43質量%の水分を含むため、投与量の1.1質量倍を秤量して補正した。懸濁液は遮光ビンにて冷蔵(4℃)保存し、調製は7日ごとに行った。EPA−Eは、用時にエパデールカプセル(大日本製薬)より採取し、精製水に懸濁して投与量が2mL/kgになるように調製した。
ラット32匹を以下の4群(各群8例)、すなわち、対照群、ピタバスタチンカルシウム単独(10mg/kg)群、EPA−E単独(1000mg/kg)群、及びピタバスタチンカルシウム(10mg/kg)及びEPA−E(1000mg/kg)併用群に血中総コレステロール及びトリグリセリドが平均化されるように群分けした。両薬物は、1日1回(午後4時)21日間反復経口投与し、対照群にはカルボキシメチルセルロースナトリウム0.5質量%水溶液1mL/kgを経口投与した。いずれの群も最終投与より18時間絶食した後に採血を行い、血中のトリグリセリド濃度を測定した。
対照群と薬物投与群間の多群比較は、Bartlettの分散分析−Dunnettの多重比較検定を用いて行い、危険率5%未満を有意差ありと判定した。
図1及び表1に示すように、血中トリグリセリドは、ピタバスタチンカルシウム及びEPA−E単独群では低下傾向であった(85.3%及び72.1%)。これに対して、両薬物併用群では、ピタバスタチン単独群に比べ、大幅に血中トリグリセリドが低下した(60.3%)。その効果は相乗効果(Burgiの式:高木敬次郎他:薬物学、1987、南山堂)が確認された(60.3%<85.3×72.1=61.5%)(p<0.01)。
Claims (6)
- ピタバスタチン類及びイコサペント酸又はそのエステル誘導体を有効成分とする高脂血症治療剤。
- ピタバスタチン類が、ピタバスタチンカルシウムである請求項1記載の高脂血症治療剤。
- イコサペント酸のエステル誘導体が、イコサペント酸エチルである請求項1又は2記載の高脂血症治療剤。
- 血中トリグリセリド低下剤である請求項1〜3のいずれか1項記載の高脂血症治療剤。
- ピタバスタチン類及びイコサペント酸又はそのエステル誘導体並びに薬学的に許容される担体を含有する高脂血症治療用組成物。
- 高脂血症治療剤の製造のためのピタバスタチン類及びイコサペント酸又はそのエステル誘導体の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/780,640 US7022713B2 (en) | 2004-02-19 | 2004-02-19 | Hyperlipemia therapeutic agent |
US10/780,640 | 2004-02-19 | ||
PCT/JP2005/003092 WO2005079797A2 (en) | 2004-02-19 | 2005-02-18 | Hyperlipemia therapeutic agent comprising pitavastatins and eicosapentaenoic acid |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2007523049A true JP2007523049A (ja) | 2007-08-16 |
JP2007523049A5 JP2007523049A5 (ja) | 2007-12-06 |
JP5474276B2 JP5474276B2 (ja) | 2014-04-16 |
Family
ID=34860884
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006525561A Expired - Fee Related JP5474276B2 (ja) | 2004-02-19 | 2005-02-18 | 高脂血症治療剤 |
Country Status (15)
Country | Link |
---|---|
US (2) | US7022713B2 (ja) |
EP (1) | EP1715865B9 (ja) |
JP (1) | JP5474276B2 (ja) |
KR (1) | KR101376449B1 (ja) |
CN (1) | CN100475208C (ja) |
AT (1) | ATE460164T1 (ja) |
CY (1) | CY1110133T1 (ja) |
DE (1) | DE602005019856D1 (ja) |
DK (1) | DK1715865T3 (ja) |
ES (1) | ES2342609T3 (ja) |
HK (1) | HK1098953A1 (ja) |
PL (1) | PL1715865T3 (ja) |
PT (1) | PT1715865E (ja) |
SI (1) | SI1715865T1 (ja) |
WO (1) | WO2005079797A2 (ja) |
Cited By (1)
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---|---|---|---|---|
JP2018048163A (ja) * | 2009-10-16 | 2018-03-29 | 持田製薬株式会社 | 組成物 |
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US20060276486A1 (en) * | 2003-04-17 | 2006-12-07 | Kowa Co., Ktd. | Lklf/klf2 gene expression promoter |
US7022713B2 (en) * | 2004-02-19 | 2006-04-04 | Kowa Co., Ltd. | Hyperlipemia therapeutic agent |
JP5069448B2 (ja) * | 2006-02-07 | 2012-11-07 | 持田製薬株式会社 | 脳卒中再発予防用組成物 |
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US8784886B2 (en) * | 2006-03-09 | 2014-07-22 | GlaxoSmithKline, LLC | Coating capsules with active pharmaceutical ingredients |
US7728697B2 (en) * | 2006-09-26 | 2010-06-01 | Mg Materials Corporation | Systems and methods for electrically reducing ferroelectric materials to increase bulk conductivity |
US20080085911A1 (en) * | 2006-10-10 | 2008-04-10 | Reliant Pharmaceuticals, Inc. | Statin and omega-3 fatty acids for reduction of apo-b levels |
US20100119600A1 (en) * | 2007-06-01 | 2010-05-13 | Joar Opheim | Substances for reducing occurrence of major cardiac events comprising red yeast rice extract and omega-3 polyunsaturated fatty acid or derivative thereof |
EP2308493A4 (en) * | 2008-07-07 | 2013-05-01 | Mochida Pharm Co Ltd | ENHANCING OR THERAPEUTIC AGENT FOR DYSLIPIDEMIA |
EP4137128A1 (en) | 2008-09-02 | 2023-02-22 | Amarin Pharmaceuticals Ireland Limited | Pharmaceutical composition comprising eicosapentaenoic acid and a statin, and methods of using same |
PT2395991E (pt) * | 2009-02-10 | 2013-09-03 | Amarin Pharmaceuticals Ie Ltd | Utilização de éster etílico de ácido eicosapentaenóico para tratamento de hipertrigliceridemia |
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RU2012116079A (ru) | 2009-09-23 | 2013-10-27 | АМАРИН КОРПОРЕЙШН ПиЭлСи | Фармацевтическая композиция, включающая омега-3 жирную кислоту и гидроксипроизводное статина и способы ее применения |
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CN102824636A (zh) * | 2012-08-15 | 2012-12-19 | 四川大学 | 一种含他汀类药物和多不饱和脂肪酸的药物组合物及其用途 |
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 |
US9814733B2 (en) | 2012-12-31 | 2017-11-14 | A,arin Pharmaceuticals Ireland Limited | Compositions comprising EPA and obeticholic acid and methods of use thereof |
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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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US10172818B2 (en) | 2014-06-16 | 2019-01-08 | Amarin Pharmaceuticals Ireland Limited | Methods of reducing or preventing oxidation of small dense LDL or membrane polyunsaturated fatty acids |
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US9895333B2 (en) | 2014-06-26 | 2018-02-20 | Patheon Softgels Inc. | Enhanced bioavailability of polyunsaturated fatty acids |
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US10966951B2 (en) | 2017-05-19 | 2021-04-06 | Amarin Pharmaceuticals Ireland Limited | Compositions and methods for lowering triglycerides in a subject having reduced kidney function |
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JP2569746B2 (ja) * | 1987-08-20 | 1997-01-08 | 日産化学工業株式会社 | キノリン系メバロノラクトン類 |
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2004
- 2004-02-19 US US10/780,640 patent/US7022713B2/en not_active Expired - Lifetime
-
2005
- 2005-02-18 DE DE602005019856T patent/DE602005019856D1/de active Active
- 2005-02-18 EP EP05710692A patent/EP1715865B9/en not_active Not-in-force
- 2005-02-18 DK DK05710692.4T patent/DK1715865T3/da active
- 2005-02-18 JP JP2006525561A patent/JP5474276B2/ja not_active Expired - Fee Related
- 2005-02-18 SI SI200531022T patent/SI1715865T1/sl unknown
- 2005-02-18 WO PCT/JP2005/003092 patent/WO2005079797A2/en not_active Application Discontinuation
- 2005-02-18 CN CNB2005800053563A patent/CN100475208C/zh not_active Expired - Fee Related
- 2005-02-18 PL PL05710692T patent/PL1715865T3/pl unknown
- 2005-02-18 KR KR1020067016099A patent/KR101376449B1/ko not_active IP Right Cessation
- 2005-02-18 AT AT05710692T patent/ATE460164T1/de active
- 2005-02-18 ES ES05710692T patent/ES2342609T3/es active Active
- 2005-02-18 PT PT05710692T patent/PT1715865E/pt unknown
- 2005-12-05 US US11/293,217 patent/US7776881B2/en not_active Expired - Fee Related
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2007
- 2007-05-28 HK HK07105572.8A patent/HK1098953A1/xx not_active IP Right Cessation
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2010
- 2010-06-03 CY CY20101100490T patent/CY1110133T1/el unknown
Patent Citations (1)
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JP2569746B2 (ja) * | 1987-08-20 | 1997-01-08 | 日産化学工業株式会社 | キノリン系メバロノラクトン類 |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2018048163A (ja) * | 2009-10-16 | 2018-03-29 | 持田製薬株式会社 | 組成物 |
JP2019031555A (ja) * | 2009-10-16 | 2019-02-28 | 持田製薬株式会社 | 組成物 |
US10668038B2 (en) | 2009-10-16 | 2020-06-02 | Mochida Pharmaceutical Co., Ltd. | Emulsion and emulsion preconcentrate compositions comprising omega-3 fatty acids and uses thereof are disclosed |
Also Published As
Publication number | Publication date |
---|---|
PL1715865T3 (pl) | 2010-09-30 |
KR101376449B1 (ko) | 2014-03-19 |
US7022713B2 (en) | 2006-04-04 |
WO2005079797A2 (en) | 2005-09-01 |
EP1715865B1 (en) | 2010-03-10 |
CN1921860A (zh) | 2007-02-28 |
US7776881B2 (en) | 2010-08-17 |
PT1715865E (pt) | 2010-04-01 |
JP5474276B2 (ja) | 2014-04-16 |
ES2342609T3 (es) | 2010-07-09 |
US20060111437A1 (en) | 2006-05-25 |
HK1098953A1 (en) | 2007-08-03 |
EP1715865B9 (en) | 2010-12-15 |
DK1715865T3 (da) | 2010-05-10 |
EP1715865A2 (en) | 2006-11-02 |
KR20060109988A (ko) | 2006-10-23 |
CY1110133T1 (el) | 2015-01-14 |
CN100475208C (zh) | 2009-04-08 |
US20050187292A1 (en) | 2005-08-25 |
SI1715865T1 (sl) | 2010-08-31 |
DE602005019856D1 (de) | 2010-04-22 |
ATE460164T1 (de) | 2010-03-15 |
WO2005079797A3 (en) | 2006-05-11 |
EP1715865B8 (en) | 2010-05-19 |
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