DK1725234T4 - Fremgangsmåder til behandling af lidelser eller sygdomme, der er forbundet med hyperlipidæmi og hyperkolesterolæmi, med minimering af bivirkninger - Google Patents

Fremgangsmåder til behandling af lidelser eller sygdomme, der er forbundet med hyperlipidæmi og hyperkolesterolæmi, med minimering af bivirkninger Download PDF

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DK1725234T4
DK1725234T4 DK05724887.4T DK05724887T DK1725234T4 DK 1725234 T4 DK1725234 T4 DK 1725234T4 DK 05724887 T DK05724887 T DK 05724887T DK 1725234 T4 DK1725234 T4 DK 1725234T4
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mtp inhibitor
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DK1725234T3 (da
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Daniel J Rader
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Univ Pennsylvania
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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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • 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
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine

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  • Health & Medical Sciences (AREA)
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  • Urology & Nephrology (AREA)
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Claims (24)

1
1. Anvendelse af en MTP-hæmmer i fremstillingen af et medikament til behandling af et individ, der lider af en lidelse, der er forbundet med hyperli-pidæmi og/eller hyperkolesterolæmi, hvor behandlingen omfatter administration af mindst tre trinvise, stigende doser af MTP-hæmmeren til individet, og hvor MTP-hæmmeren har strukturen:
η Γ II eller et farmaceutisk acceptabelt salt deraf eller piperidin N-oxidet deraf.
2. MTP-hæmmer til anvendelse i behandling af et individ, der lider af en lidelse, der er forbundet med hyperlipidæmi og/eller hyperkolesterolæmi, hvor behandlingen omfatter administration af mindst tre trinvise, stigende doser af MTP-hæmmeren til individet, og hvor MTP-hæmmeren har strukturen:
eller et farmaceutisk acceptabelt salt deraf eller piperidin N-oxidet deraf.
3. Anvendelse ifølge krav 1 eller en MTP-hæmmer til anvendelse ifølge krav 2, hvor forstyrrelsen er svær hyperkolesterolæmi. 2
4. Anvendelse ifølge krav 1 eller krav 3 eller en MTP-hæmmer til anvendelse ifølge krav 2 eller krav 3, hvor MTP-hæmmeren administreres oralt.
5. Anvendelse ifølge et hvilket som helst af kravene 1, 3 og 4 eller en MTP-hæmmer til anvendelse ifølge et hvilket som helst af kravene 2 til 4, hvor de eskalerende doser omfatter mindst et første dosisniveau, et andet dosisniveau og et tredje dosisniveau.
6. Anvendelse ifølge krav 5 eller en MTP-hæmmer til anvendelse ifølge krav 5, hvor de eskalerende doser endvidere omfatter et fjerde dosisniveau.
7. Anvendelse ifølge krav 5 eller en MTP-hæmmer til anvendelse ifølge krav 5, hvor de eskalerende doser endvidere omfatter et fjerde og et femte dosisniveau.
8. Anvendelse ifølge krav 7 eller en MTP-hæmmer til anvendelse ifølge krav 7, hvor det første dosisniveau er 6,25 mg/dag, det andet dosisniveau er 12,5 mg/dag, det tredje dosisniveau er 25 mg/dag, det fjerde dosisniveau er 37,5 mg/dag og det femte dosisniveau er 50 mg/dag.
9. Anvendelse ifølge et hvilket som helst af kravene 1 og 3 til 7 eller en MTP-hæmmer til anvendelse ifølge et hvilket som helst af kravene 2 til 7, hvor hvert af de eskalerende dosisniveauer ikke er mere end 50 % af det umiddelbart efterfølgende dosisniveau.
10. Anvendelse ifølge et hvilket som helst af kravene 1 og 3 til 7 eller en MTP-hæmmer til anvendelse ifølge et hvilket som helst af kravene 2 til 7, hvor hvert af de eskalerende dosisniveauer ikke er mere end 20 % af det umiddelbart efterfølgende dosisniveau.
11. Anvendelse ifølge krav 7 eller en MTP-hæmmer til anvendelse ifølge krav 7, hvor det første dosisniveau er fra ca. 2 til ca. 13 mg/dag, det andet dosisniveau er fra ca. 5 til ca. 30 mg/dag, og det tredje dosisniveau er fra ca. 10 til ca. 50 mg/dag, det fjerde dosisniveau er fra ca. 20 til ca. 60 mg/dag, og det femte dosisniveau er fra ca. 30 til ca. 75 mg/dag. 3
12. Anvendelse ifølge krav 6 eller en MTP-hæmmer til anvendelse ifølge krav 6, hvor det første dosisniveau er 12,5 mg/dag, det andet dosisniveau er 25 mg/dag, det tredje dosisniveau er 37,5 mg/dag, og det fjerde dosisniveau er 50 mg/dag.
13. Anvendelse ifølge krav 5 eller en MTP-hæmmer til anvendelse ifølge krav 5, hvor det første dosisniveau er 6,25 mg/dag, det andet dosisniveau er 12,5 mg/dag, og det tredje dosisniveau er 50 mg/dag.
14. Anvendelse ifølge et hvilket som helst af kravene 1 og 3 til 13 eller en MTP-hæmmer til anvendelse ifølge et hvilket som helst af kravene 2 til 13, hvor MTP-hæmmeren administreres til individet i kombination med en yderligere lipidmodificerende forbindelse.
15. Anvendelse ifølge krav 14 eller en MTP-hæmmer til anvendelse ifølge krav 14, hvor de lipidmodificerende forbindelser er udvalgt fra gruppen bestående af HMG CoA-reduktasehæmmere, kolesterolabsorptionshæmmere, ezetimib, squalensyntetasehæmmere, fibrater, galdesyresekvestranter, stati-ner, probucol og derivater, niacin, niacinderivater, PPAR alfa-agonister, fibrater, PPAR gamma-agonister, thiazolidinedioner og kolesterolestertransferpro-tein(CEPT)-hæmmere.
16. Anvendelse ifølge et hvilket som helst af kravene 1 og 3 til 13 eller en MTP-hæmmer til anvendelse ifølge et hvilket som helst af kravene 2 til 13, hvor hvert dosisniveau administreres til individet i fra ca. 1 til 4 uger.
17. Anvendelse ifølge krav 14 eller en MTP-hæmmer til anvendelse ifølge krav 14, hvor MTP-hæmmeren og de lipidmodificerende forbindelser er til stede i samme doseringsenhed.
18. Anvendelse af en MTP-hæmmer i fremstillingen af et medikament til behandling af et individ, der lider af en lidelse, der er udvalgt fra gruppen bestående af homozygotisk/heterozygotisk familiær hyperkolesterolæmi eller hy-pertriglyceridæmi, hvor MTP-hæmmeren har strukturen: 4
eller et farmaceutisk acceptabelt salt deraf eller piperidin N-oxidet deraf.
19. MTP-hæmmer til anvendelse i behandling af et individ, der lider af en lidelse, der er udvalgt fra gruppen bestående af homozygotisk/heterozygotisk familiær hyperkolesterolæmi eller hypertriglyceridæmi, hvor MTP-hæmmeren |-iar ctri ikti iran
eller et farmaceutisk acceptabelt salt deraf eller piperidin N-oxidet deraf.
20. Anvendelse ifølge krav 18 eller en MTP-hæmmer til anvendelse ifølge krav 19, hvor MTP-hæmmeren administreres til individet i kombination med en yderligere lipidmodificerende forbindelse.
21. Anvendelse ifølge krav 18 eller krav 20 eller en MTP-hæmmer til anvendelse ifølge krav 19 eller krav 20, hvor én eller flere af total kolesterol, LDL, fastende triglycerider (TG), VLDL, lipoprotein (a) (Lp(a)), og apolipoproteiner A-l, A-ll, B, og E reduceres med mindst 15 %, sammenlignet med kontrolniveauer.
22. Anvendelse ifølge et hvilket som helst af kravene 18, 20 og 21 eller en MTP-hæmmer ifølge et hvilket som helst af kravene 19 til 21, hvor de lipid- 5 modificerende forbindelser er udvalgt fra gruppen bestående af HMG CoA-reduktasehæmmere, kolesterolabsorptionshæmmere, ezetimib, squalensyn-tetasehæmmere, fibrater, galdesyresekvestranter, statiner, probucol og derivater, niacin, niacinderivater, PPAR alfa-agonister, fibrater, PPAR gamma-agonister, thiazolidinedioner og kolesterolestertransferprotein(CEPT)-hæmmere.
23. Kit til behandling af en lidelse, der er forbundet med hyperlipidæmi og/eller hyperkolesterolæmi hos et individ, omfattende: a) mindst fire sæt farmaceutiske doseringsenheder af en MTP-hæmmer, hvor et første sæt doseringsenheder tilvejebringer 6,25 mg/dag til et første interval, et andet sæt doseringsenheder tilvejebringer 12,5 mg/dag til et andet interval, et tredje sæt doseringsenheder tilvejebringer 37,5 mg/dag til et tredje interval, et fjerde sæt doseringsenheder tilvejebringer 50 mg/dag til et fjerde interval; og b) anvisninger for anvendelse; hvor MTP-hæmmeren har strukturen:
eller et farmaceutisk acceptabelt salt deraf eller piperidin N-oxidet deraf.
24. Kit til behandling af en lidelse, der er forbundet med hyperlipidæmi og/eller hyperkolesterolæmi hos et individ, omfattende: a) mindst fem sæt farmaceutiske doseringsenheder af en MTP-hæmmer, hvor et første sæt doseringsenheder tilvejebringer fra ca. 2 til ca. 13 mg/dag til et første interval, et andet sæt doseringsenheder tilvejebringer fra ca. 5 til ca. 30 mg/dag til et andet interval, et tredje sæt doseringsenheder tilvejebringer fra ca. 10 til ca. 50 mg/dag til et tredje interval, et fjerde sæt doseringsenheder tilvejebringer fra ca. 20 til ca. 60 mg/dag til et fjerde interval, og et 6 femte sæt doseringsenheder tilvejebringer fra ca. 30 til ca. 75 mg/dag til et femte interval; og b) anvisninaer for anvendelse:
ener et rarmaceutisK acceptaoeit salt deraf eller piperidin N-oxidet deraf.
DK05724887.4T 2004-03-05 2005-03-07 Fremgangsmåder til behandling af lidelser eller sygdomme, der er forbundet med hyperlipidæmi og hyperkolesterolæmi, med minimering af bivirkninger DK1725234T4 (da)

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US55091504P 2004-03-05 2004-03-05
PCT/US2005/007435 WO2005087234A1 (en) 2004-03-05 2005-03-07 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects

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DK1725234T3 DK1725234T3 (da) 2013-02-18
DK1725234T4 true DK1725234T4 (da) 2016-05-09

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US (11) US7932268B2 (da)
EP (1) EP1725234B2 (da)
JP (4) JP5697296B2 (da)
KR (2) KR101494067B1 (da)
AU (1) AU2005221656B2 (da)
CA (2) CA2558766A1 (da)
CY (2) CY1114218T1 (da)
DK (1) DK1725234T4 (da)
ES (1) ES2399721T5 (da)
HR (1) HRP20130115T4 (da)
LT (1) LTC1725234I2 (da)
ME (1) ME02070B (da)
NL (1) NL300634I2 (da)
NZ (1) NZ549721A (da)
PL (1) PL1725234T5 (da)
PT (1) PT1725234E (da)
RS (1) RS52825B2 (da)
SI (2) SI1725234T2 (da)
WO (1) WO2005087234A1 (da)

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