DE60220084T2 - Die verwendung einer spezifischen dosis von fondaparinux natrium zur behandlung des akuten koronaren syndroms - Google Patents
Die verwendung einer spezifischen dosis von fondaparinux natrium zur behandlung des akuten koronaren syndroms Download PDFInfo
- Publication number
- DE60220084T2 DE60220084T2 DE60220084T DE60220084T DE60220084T2 DE 60220084 T2 DE60220084 T2 DE 60220084T2 DE 60220084 T DE60220084 T DE 60220084T DE 60220084 T DE60220084 T DE 60220084T DE 60220084 T2 DE60220084 T2 DE 60220084T2
- Authority
- DE
- Germany
- Prior art keywords
- treatment
- fondaparinux sodium
- dose
- bleeding
- acs
- 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.)
- Expired - Lifetime
Links
- 208000004476 Acute Coronary Syndrome Diseases 0.000 title claims description 20
- 238000011282 treatment Methods 0.000 title claims description 16
- XEKSTYNIJLDDAZ-JASSWCPGSA-F fondaparinux sodium Chemical compound [Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].O[C@@H]1[C@@H](NS([O-])(=O)=O)[C@@H](OC)O[C@H](COS([O-])(=O)=O)[C@H]1O[C@H]1[C@H](OS([O-])(=O)=O)[C@@H](O)[C@H](O[C@@H]2[C@@H]([C@@H](OS([O-])(=O)=O)[C@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O[C@@H]4[C@@H]([C@@H](O)[C@H](O)[C@@H](COS([O-])(=O)=O)O4)NS([O-])(=O)=O)[C@H](O3)C(O)=O)O)[C@@H](COS([O-])(=O)=O)O2)NS([O-])(=O)=O)[C@H](C(O)=O)O1 XEKSTYNIJLDDAZ-JASSWCPGSA-F 0.000 title claims 2
- 229960003661 fondaparinux sodium Drugs 0.000 title description 19
- 239000003814 drug Substances 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 5
- -1 2-deoxy-2-sulfoamino-6-O-sulfo-α-D-glucopyranosyl Chemical group 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims description 2
- AEMOLEFTQBMNLQ-QIUUJYRFSA-N beta-D-glucuronic acid Chemical class O[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-QIUUJYRFSA-N 0.000 claims 1
- XEKSTYNIJLDDAZ-JASSWCPGSA-D decasodium;(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5r,6r)-6-[(2r,3s,4s,5r,6r)-2-carboxylato-4-hydroxy-6-[(2r,3s,4r,5r,6s)-4-hydroxy-6-methoxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl)oxan-3-yl]oxy-5-sulfonatooxyoxan-3-yl]oxy-5-(sulfonatoamino)-4-sulfonatooxy-2-(sul Chemical compound [Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].O[C@@H]1[C@@H](NS([O-])(=O)=O)[C@@H](OC)O[C@H](COS([O-])(=O)=O)[C@H]1O[C@H]1[C@H](OS([O-])(=O)=O)[C@@H](O)[C@H](O[C@@H]2[C@@H]([C@@H](OS([O-])(=O)=O)[C@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O[C@@H]4[C@@H]([C@@H](O)[C@H](O)[C@@H](COS([O-])(=O)=O)O4)NS([O-])(=O)=O)[C@H](O3)C([O-])=O)O)[C@@H](COS([O-])(=O)=O)O2)NS([O-])(=O)=O)[C@H](C([O-])=O)O1 XEKSTYNIJLDDAZ-JASSWCPGSA-D 0.000 description 24
- 208000032843 Hemorrhage Diseases 0.000 description 21
- 208000034158 bleeding Diseases 0.000 description 20
- 230000000740 bleeding effect Effects 0.000 description 20
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 19
- 231100000517 death Toxicity 0.000 description 17
- 230000034994 death Effects 0.000 description 17
- 229960000610 enoxaparin Drugs 0.000 description 13
- 206010000891 acute myocardial infarction Diseases 0.000 description 12
- 208000028867 ischemia Diseases 0.000 description 9
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 230000000306 recurrent effect Effects 0.000 description 6
- 208000010125 myocardial infarction Diseases 0.000 description 5
- 206010051055 Deep vein thrombosis Diseases 0.000 description 4
- 108090000190 Thrombin Proteins 0.000 description 4
- 208000007814 Unstable Angina Diseases 0.000 description 4
- 206010047249 Venous thrombosis Diseases 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 229960004072 thrombin Drugs 0.000 description 4
- 206010002388 Angina unstable Diseases 0.000 description 3
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 229960001138 acetylsalicylic acid Drugs 0.000 description 3
- 239000003146 anticoagulant agent Substances 0.000 description 3
- 238000001647 drug administration Methods 0.000 description 3
- 201000004332 intermediate coronary syndrome Diseases 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 230000002785 anti-thrombosis Effects 0.000 description 2
- 230000002354 daily effect Effects 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 229960002897 heparin Drugs 0.000 description 2
- 229920000669 heparin Polymers 0.000 description 2
- 230000000302 ischemic effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000010197 meta-analysis Methods 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 238000011321 prophylaxis Methods 0.000 description 2
- 238000003786 synthesis reaction Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 1
- 208000037260 Atherosclerotic Plaque Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 206010011091 Coronary artery thrombosis Diseases 0.000 description 1
- 108010029144 Factor IIa Proteins 0.000 description 1
- 108010074860 Factor Xa Proteins 0.000 description 1
- 229940123583 Factor Xa inhibitor Drugs 0.000 description 1
- 102000009123 Fibrin Human genes 0.000 description 1
- 108010073385 Fibrin Proteins 0.000 description 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 229920002683 Glycosaminoglycan Polymers 0.000 description 1
- 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
- 206010056457 Intra-abdominal haematoma Diseases 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 206010066901 Treatment failure Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 229910001413 alkali metal ion Inorganic materials 0.000 description 1
- 229910001420 alkaline earth metal ion Inorganic materials 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 238000013176 antiplatelet therapy Methods 0.000 description 1
- 229940127217 antithrombotic drug Drugs 0.000 description 1
- 239000007900 aqueous suspension Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 238000003776 cleavage reaction Methods 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000002586 coronary angiography Methods 0.000 description 1
- 238000007887 coronary angioplasty Methods 0.000 description 1
- 208000002528 coronary thrombosis Diseases 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229950003499 fibrin Drugs 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 230000005802 health problem Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 239000003055 low molecular weight heparin Substances 0.000 description 1
- 229940127215 low-molecular weight heparin Drugs 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 230000000116 mitigating effect Effects 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 231100001160 nonlethal Toxicity 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000000250 revascularization Effects 0.000 description 1
- 231100000279 safety data Toxicity 0.000 description 1
- 239000012266 salt solution Substances 0.000 description 1
- 230000007017 scission Effects 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000002537 thrombolytic effect Effects 0.000 description 1
- 238000012384 transportation and delivery Methods 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000000080 wetting agent Substances 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7024—Esters of saccharides
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
-
- 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
-
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Saccharide Compounds (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP01204323 | 2001-11-13 | ||
| EP01204323 | 2001-11-13 | ||
| PCT/EP2002/012482 WO2003041722A1 (en) | 2001-11-13 | 2002-11-07 | Use of specific dose of fondaparinux sodium for the treatment of acs |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE60220084D1 DE60220084D1 (de) | 2007-06-21 |
| DE60220084T2 true DE60220084T2 (de) | 2008-01-10 |
Family
ID=8181220
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE60220084T Expired - Lifetime DE60220084T2 (de) | 2001-11-13 | 2002-11-07 | Die verwendung einer spezifischen dosis von fondaparinux natrium zur behandlung des akuten koronaren syndroms |
Country Status (36)
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090075910A1 (en) * | 2007-09-13 | 2009-03-19 | Protia, Llc | Deuterium-enriched fondaparinux |
| EP3271405A1 (en) * | 2015-03-20 | 2018-01-24 | Aarhus Universitet | Inhibitors of pcsk9 for treatment of lipoprotein metabolism disorders |
| US10688249B2 (en) * | 2015-06-11 | 2020-06-23 | Virchow Biotech Pvt. Ltd. | Multiple dose pharmaceutical compositions containing heparin and/or heparin-like compounds and devices and methods for delivering the same |
| CN107595769A (zh) * | 2017-10-23 | 2018-01-19 | 上海博悦生物科技有限公司 | 一种磺达肝癸钠注射液组合物的制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2662442A1 (fr) * | 1990-05-23 | 1991-11-29 | Midy Spa | Trifluoromethylphenyltetrahydropyridines n-substituees procede pour leur preparation, intermediaires du procede et compositions pharmaceutiques les contenant. |
| CA2199642C (en) * | 1997-03-10 | 2001-05-08 | Roger Cariou | Compositions containing an association of aspirin and an anti-xa oligosaccharide and use of an anti-xa oligosaccharide optionally in combination with aspirin |
| FR2764511B1 (fr) * | 1997-06-13 | 2000-09-08 | Sanofi Sa | Compositions pour le traitement et la prevention de la thrombose arterielle et utilisation d'un inhibiteur du facteur xa seul et/ou en combinaison avec un antiagregant plaquettaire |
| JP2006501815A (ja) * | 2002-04-25 | 2006-01-19 | モメンタ ファーマシューティカルズ インコーポレイテッド | 粘膜送達のための方法および製品 |
-
2002
- 2002-07-11 UA UA2004032373A patent/UA80399C2/uk unknown
- 2002-11-07 AT AT02787601T patent/ATE361753T1/de active
- 2002-11-07 AU AU2002351915A patent/AU2002351915B2/en not_active Expired
- 2002-11-07 MX MXPA04003045A patent/MXPA04003045A/es active IP Right Grant
- 2002-11-07 PE PE2002001086A patent/PE20030740A1/es not_active Application Discontinuation
- 2002-11-07 CA CA002465776A patent/CA2465776A1/en not_active Abandoned
- 2002-11-07 BR BR0212915-9A patent/BR0212915A/pt not_active Application Discontinuation
- 2002-11-07 PT PT02787601T patent/PT1446131E/pt unknown
- 2002-11-07 RS YUP-267/04A patent/RS50906B/sr unknown
- 2002-11-07 SI SI200230578T patent/SI1446131T1/sl unknown
- 2002-11-07 HU HU0401462A patent/HU228959B1/hu unknown
- 2002-11-07 CN CNA028192567A patent/CN1602197A/zh active Pending
- 2002-11-07 GE GE5516A patent/GEP20074097B/en unknown
- 2002-11-07 KR KR1020047004779A patent/KR20050044318A/ko not_active Ceased
- 2002-11-07 HR HR20040303A patent/HRP20040303B1/xx not_active IP Right Cessation
- 2002-11-07 PL PL369027A patent/PL206008B1/pl unknown
- 2002-11-07 NZ NZ552129A patent/NZ552129A/en not_active IP Right Cessation
- 2002-11-07 EA EA200400382A patent/EA007325B1/ru unknown
- 2002-11-07 AP APAP/P/2004/003014A patent/AP1820A/en active
- 2002-11-07 US US10/492,102 patent/US20040248848A1/en not_active Abandoned
- 2002-11-07 ME MEP-2008-11A patent/ME00229B/me unknown
- 2002-11-07 IL IL16111402A patent/IL161114A0/xx unknown
- 2002-11-07 WO PCT/EP2002/012482 patent/WO2003041722A1/en not_active Ceased
- 2002-11-07 ME MEP-11/08A patent/MEP1108A/xx unknown
- 2002-11-07 JP JP2003543609A patent/JP4523276B2/ja not_active Expired - Fee Related
- 2002-11-07 EP EP02787601A patent/EP1446131B1/en not_active Expired - Lifetime
- 2002-11-07 DK DK02787601T patent/DK1446131T3/da active
- 2002-11-07 DE DE60220084T patent/DE60220084T2/de not_active Expired - Lifetime
- 2002-11-07 ES ES02787601T patent/ES2287343T3/es not_active Expired - Lifetime
- 2002-11-11 AR ARP020104308A patent/AR037291A1/es unknown
-
2004
- 2004-03-25 IL IL161114A patent/IL161114A/en active IP Right Grant
- 2004-03-29 ZA ZA2004/02464A patent/ZA200402464B/en unknown
- 2004-03-29 IS IS7199A patent/IS2484B/is unknown
- 2004-03-30 NO NO20041320A patent/NO20041320L/no not_active Application Discontinuation
- 2004-03-31 MA MA27602A patent/MA27071A1/fr unknown
- 2004-03-31 EC EC2004005041A patent/ECSP045041A/es unknown
- 2004-03-31 CO CO04030711A patent/CO5580790A2/es not_active Application Discontinuation
-
2007
- 2007-07-30 CY CY20071101000T patent/CY1106765T1/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8364 | No opposition during term of opposition |