JP4914714B2 - 脂質代謝異常の予防または治療用医薬組成物 - Google Patents
脂質代謝異常の予防または治療用医薬組成物 Download PDFInfo
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- JP4914714B2 JP4914714B2 JP2006512970A JP2006512970A JP4914714B2 JP 4914714 B2 JP4914714 B2 JP 4914714B2 JP 2006512970 A JP2006512970 A JP 2006512970A JP 2006512970 A JP2006512970 A JP 2006512970A JP 4914714 B2 JP4914714 B2 JP 4914714B2
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Classifications
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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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/4035—Isoindoles, e.g. phthalimide
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
-
- 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
-
- 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
- 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
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Diabetes (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Obesity (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Indole Compounds (AREA)
Description
(1)前記式(I)で表されるミチグリニド若しくはその薬理学的に許容される塩、またはそれらの水和物を有効成分として含有する、脂質代謝異常の予防または治療用医薬組成物;
(2)脂質代謝異常が糖尿病、耐糖能異常及び空腹時血糖異常から選択される1以上のものに併発するものである、前記(1)記載の医薬組成物;
(3)脂質代謝異常が糖尿病に併発するものである、前記(2)記載の医薬組成物;
(4)脂質代謝異常が高脂血症、高トリグリセリド血症、高コレステロール血症、高LDLコレステロール血症、および低HDLコレステロール血症、食後高脂血症から選択される1以上のものである、前記(1)〜(3)のいずれかに記載の医薬組成物;
(5)有効成分がミチグリニドカルシウム水和物である、前記(1)〜(5)のいずれかに記載の医薬組成物;等に関するものである。
ミチグリニドカルシウム水和物5mgを含有する錠剤およびミチグリニドカルシウム水和物10mgを含有する錠剤を用いて、2型糖尿病患者を対象として、以下のような臨床試験を行った。
対象患者:2型糖尿病患者
投与方法:1回5〜20mgの範囲で1日3回毎食直前(食前5分前)経口投与
投与期間:28週間〜52週間
主な観察項目:安定型ヘモグロビンA1c(HbA1c)、血液生化学検査(総コレステロール、トリグリセリド、LDLコレステロール、HDLコレステロール、遊離脂肪酸)
解析方法: 投与開始前の各脂質検査値が異常値であり、かつ脂質低下剤を全く併用しなかった全症例を対象とし、最終評価時の平均値の投与開始前平均値に対する有意差検定を行った(*: P<0.05, **: P<0.01)。
(1)血清トリグリセライド(TG)の変化量
投与開始前の血清TGが150mg/dL以上の患者を異常例として抽出し、ミチグリニドカルシウム水和物の効果を検討した。結果を表1に示す。
(3)その他の脂質異常値の変化量
投与開始前の血清遊離脂肪酸(FFA)、LDLコレステロール(LDL-C)、HDLコレステロール(HDL-C)が、それぞれ0.86mEq/L以上、120mg/dL以上、40mg/dL未満の患者をそれぞれ異常例として抽出し、ミチグリニドカルシウム水和物の効果を検討した。結果を表3に示す。
Claims (7)
- ミチグリニドもしくはその薬理学的に許容される塩、またはそれらの水和物を有効成分として含有する、脂質代謝異常の予防または治療用医薬組成物。
- 脂質代謝異常が糖尿病、耐糖能異常及び空腹時血糖異常から選択される1以上のものに併発するものである、請求項1記載の医薬組成物。
- 脂質代謝異常が糖尿病に併発するものである、請求項2記載の医薬組成物。
- 脂質代謝異常が高脂血症である、請求項1〜3のいずれかに記載の医薬組成物。
- 脂質代謝異常が高トリグリセリド血症、高コレステロール血症、高LDLコレステロール血症、および低HDLコレステロール血症から選択される1以上のものである、請求項1〜3のいずれかに記載の医薬組成物。
- 脂質代謝異常が食後高脂血症である、請求項1〜3のいずれかに記載の医薬組成物。
- 有効成分がミチグリニドカルシウム水和物である、請求項1〜6のいずれかに記載の医薬組成物。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2006512970A JP4914714B2 (ja) | 2004-05-11 | 2005-04-27 | 脂質代謝異常の予防または治療用医薬組成物 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2004141634 | 2004-05-11 | ||
JP2004141634 | 2004-05-11 | ||
PCT/JP2005/008066 WO2005107746A1 (ja) | 2004-05-11 | 2005-04-27 | 脂質代謝異常の予防または治療用医薬組成物 |
JP2006512970A JP4914714B2 (ja) | 2004-05-11 | 2005-04-27 | 脂質代謝異常の予防または治療用医薬組成物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPWO2005107746A1 JPWO2005107746A1 (ja) | 2008-03-21 |
JP4914714B2 true JP4914714B2 (ja) | 2012-04-11 |
Family
ID=35320026
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006512970A Expired - Fee Related JP4914714B2 (ja) | 2004-05-11 | 2005-04-27 | 脂質代謝異常の予防または治療用医薬組成物 |
Country Status (8)
Country | Link |
---|---|
US (1) | US7666899B2 (ja) |
EP (1) | EP1757287A4 (ja) |
JP (1) | JP4914714B2 (ja) |
KR (1) | KR101262123B1 (ja) |
CN (1) | CN1976696B (ja) |
CA (1) | CA2565878A1 (ja) |
TW (1) | TWI365070B (ja) |
WO (1) | WO2005107746A1 (ja) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP4914714B2 (ja) * | 2004-05-11 | 2012-04-11 | キッセイ薬品工業株式会社 | 脂質代謝異常の予防または治療用医薬組成物 |
KR20210151338A (ko) | 2020-06-05 | 2021-12-14 | 주식회사 하람 | 비스페놀류에 의한 이상 지질대사 개선 조성물 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU654331B2 (en) * | 1991-03-30 | 1994-11-03 | Kissei Pharmaceutical Co. Ltd. | Succinic acid compounds |
JP2686863B2 (ja) * | 1991-04-25 | 1997-12-08 | キッセイ薬品工業株式会社 | 新規なベンジルコハク酸誘導体 |
PT1179342E (pt) * | 1999-05-21 | 2006-07-31 | Kissei Pharmaceutical | Composicoes medicinais de libertacao imediata para utilizacao oral |
WO2001062295A1 (fr) * | 2000-02-24 | 2001-08-30 | Takeda Chemical Industries, Ltd. | Medicaments contenant des ingredients actifs combines |
PE20020617A1 (es) * | 2000-08-22 | 2002-08-05 | Novartis Ag | Composicion que comprende un antagonista del receptor at1 y un potenciador de la secrecion de insulina o un sensibilizante a la insulina |
TW200810743A (en) * | 2002-03-22 | 2008-03-01 | Novartis Ag | Combination of organic compounds |
US7176194B2 (en) * | 2002-06-19 | 2007-02-13 | Sanofi-Aventis Deutschland Gmbh | Ring-substituted diphenylazetidinones, process for their preparation, medicaments comprising these compounds, and their use |
CA2490250A1 (en) * | 2002-06-28 | 2004-01-08 | Kissei Pharmaceutical Co., Ltd. | Drug composition for blood sugar control |
US20050215607A1 (en) | 2002-06-28 | 2005-09-29 | Imao Mikoshiba | Drug composition for prevention or inhibition of advance of diabetic complication |
JP4914714B2 (ja) * | 2004-05-11 | 2012-04-11 | キッセイ薬品工業株式会社 | 脂質代謝異常の予防または治療用医薬組成物 |
-
2005
- 2005-04-27 JP JP2006512970A patent/JP4914714B2/ja not_active Expired - Fee Related
- 2005-04-27 CA CA002565878A patent/CA2565878A1/en not_active Abandoned
- 2005-04-27 US US11/596,109 patent/US7666899B2/en not_active Expired - Fee Related
- 2005-04-27 EP EP05737344A patent/EP1757287A4/en not_active Withdrawn
- 2005-04-27 WO PCT/JP2005/008066 patent/WO2005107746A1/ja active Application Filing
- 2005-04-27 CN CN2005800214368A patent/CN1976696B/zh not_active Expired - Fee Related
- 2005-05-09 TW TW094114867A patent/TWI365070B/zh not_active IP Right Cessation
-
2006
- 2006-11-13 KR KR1020067023734A patent/KR101262123B1/ko active IP Right Grant
Also Published As
Publication number | Publication date |
---|---|
TWI365070B (en) | 2012-06-01 |
US20080021086A1 (en) | 2008-01-24 |
TW200600094A (en) | 2006-01-01 |
CA2565878A1 (en) | 2005-11-17 |
WO2005107746A1 (ja) | 2005-11-17 |
EP1757287A1 (en) | 2007-02-28 |
CN1976696A (zh) | 2007-06-06 |
EP1757287A4 (en) | 2009-11-25 |
KR20070011488A (ko) | 2007-01-24 |
CN1976696B (zh) | 2010-10-06 |
KR101262123B1 (ko) | 2013-05-14 |
US7666899B2 (en) | 2010-02-23 |
JPWO2005107746A1 (ja) | 2008-03-21 |
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