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WO2001056609A1 - Composition pharmaceutique destinee au traitement d'une hyperhomocysteinemie provoquee par un medicament - Google Patents

Composition pharmaceutique destinee au traitement d'une hyperhomocysteinemie provoquee par un medicament Download PDF

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Publication number
WO2001056609A1
WO2001056609A1 PCT/EP2000/008801 EP0008801W WO0156609A1 WO 2001056609 A1 WO2001056609 A1 WO 2001056609A1 EP 0008801 W EP0008801 W EP 0008801W WO 0156609 A1 WO0156609 A1 WO 0156609A1
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WO
WIPO (PCT)
Prior art keywords
acid
pharmaceutical
pharmaceutical composition
nicotinic acid
combination
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.)
Ceased
Application number
PCT/EP2000/008801
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German (de)
English (en)
Inventor
Sabine Westphal
Jutta Dierkes
Klaus Luley
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Individual
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Individual
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Application filed by Individual filed Critical Individual
Priority to AU2000272858A priority Critical patent/AU2000272858A1/en
Publication of WO2001056609A1 publication Critical patent/WO2001056609A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K31/33—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
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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

Definitions

  • composition for the treatment of drug-induced hyperhomocysteinemia is provided.
  • the invention relates to a pharmaceutical composition for the therapy of hyperhomocysteinemia, which, for. B. induced by therapy with antihypertensive drugs, analgesics, antidepressants, immunosuppressants, H 2 -receptor blockers, antiepeleptics, methylxanthines, biguanides or lipid-lowering agents.
  • hyperhomocysteinemia increased levels of the amino acid homocysteine in the blood plasma
  • anti-hypertensive drugs diuretics, calcium antagonists, ACE inhibitors or angiotensin-II receptor antagonists
  • non-steroidal analgesics non-steroidal analgesics
  • antidepressants lithium
  • Immunosuppressants methylxanthines (theophylline)
  • biguanides metalformin
  • lipid-lowering agents foribrates, anion exchangers, nicotinic acid and nicotinic acid analogues.
  • Elevated homocysteine levels represent a risk factor for the development of coronary heart disease, apoplexy and peripheral occlusive disease. Treatment of these elevated homocysteine levels is therefore carried out as part of the prevention of coronary artery disease, apoplexy and peripheral occlusive disease. Congenital and acquired causes of hyperhomocysteinemia are known. Deficiency of the vitamins cobalamin (vitamin B12), folic acid or pyridoxine chloride (vitamin B6) are a common cause of hyperhomocysteinemia. B vitamins and folic acid have important coenzyme functions in the breakdown of homocysteine.
  • the therapy consists in the targeted vitamin substitution of folic acid, vitamin B6 or B12 (O. Stanger; metabolism, news about the risk factor homocysteine, medical journal Dr. Med. 06/99). It is therefore an object of the invention to prevent the development of drug-induced hyperhomocysteinemia by means of suitable active ingredient additions.
  • a pharmaceutical composition comprising a combination of a pharmaceutical active ingredient inducing hyperhomocysteinemia and at least one or more of the active ingredients cobalamin (cyano-, hydroxo-, methyl-), folic acid (pteroyiglutamic acid, methyltetrahydrofolate, folinic acid), vitamin B6 (pyridoxine chloride) , Betaine or N-acetylcysteine is suitable, can prevent an increase in the homocysteine concentration in the blood plasma, as has been observed with the administration of blood pressure-lowering drugs, analgesics, antidepressants, immunosuppressants, H 2 -receptors, antiepeleptics, methylxanthines, biguanides or lipid-lowering drugs ,
  • the following table shows the effect of antihypertensive therapy on parameters of homocysteine metabolism in patients with high blood pressure.
  • the median with the smallest and the largest value in brackets or the mean with simple standard deviation is given.
  • the probability of error (p-value values) was determined using the Wilcoxon test for connected samples.
  • Vitamin B6 (PLP) (ng / mL) 9.0 (5.0-39.4) 10.9 (5.2-39.3) 0.10
  • Vitamin B12 (cobalamin) 369 (217-1115) 358 (123-907) 0.75
  • Vitamin B6 (PLP) (ng / mL) 9.0 (5.1-36.4) 10.3 (4.7-25.9) 0.53
  • homocysteine-lowering active ingredients are used in combination with the pharmaceutical active ingredients inducing hyperhomocysteinemia in the following daily doses for the indicated indications:
  • N-acetylcysteine up to 5,000 mg
  • the combination of the active pharmaceutical ingredients with the vitamins mentioned can preferably be taken orally, e.g. B. in the form of capsules, dragees, tablets, tablets or film tablets.
  • the combination of the active pharmaceutical ingredients with betaine or N-acetylcysteine can preferably be administered orally, e.g. B. in the form of an effervescent tablet.
  • the present invention includes pharmaceutical preparations which, in addition to non-toxic, inert pharmaceutically suitable excipients, which contain the compounds according to the invention, and processes for the preparation of these preparations.
  • suitable pharmaceutical preparations are as follows:
  • the pharmaceutical preparations listed can also contain other active pharmaceutical ingredients.
  • the pharmaceutical preparations listed above are prepared in a customary manner by known methods, e.g. by mixing the active ingredient (s) with the excipient (s).
  • diuretics calcium antagonists, ACE inhibitors and angiotensin-II receptor antagonists
  • Active substances that belong to the class of diuretics, calcium antagonists, ACE inhibitors or angiotensin-II receptor antagonists are listed in Table 1.
  • Other side effects than the newly found hyperhomocysteinemia when taking these antihypertensive agents are already known.
  • the patient was given a pharmaceutical preparation according to the invention as

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (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)

Abstract

L'invention concerne une composition pharmaceutique destinée à la fabrication de bloqueurs de récepteurs de H2 (cimétidine), d'analgésiques non-stéroïdiques (ibuprofène, indométacine), d'antidépresseurs (lithium), d'antiépiléptiques (phénytoïne, carbamazépine), d'immunosuppresseurs (cyclosporine, méthotrexate), de méthylxanthines (théophylline), de biguanides (métformine), et d'hypolipidémiants (fibrates, échangeurs d'anions, acide nicotinique et analogues d'acide nicotinique), ou d'agents pharmaceutiques destinés au traitement de l'hypertension et contenant une combinaison d'un agent actif provoquant une hyperhomocystéinémie et au moins un des agents actifs suivants ; cobalamine (cyano-, hydroxy-, méthyl-), acide folique (acide ptéroglutaminique, méthyltétrahydrofolate, acide folinique), vitamine B6 (chlorure de pyridoxine), bétaïne ou N-acétylcystéine. Selon une nouvelle observation, une hyperhomocystéinémie (concentration élevée de l'acide aminé homocystéine dans le plasma sanguin) est induite par la prise d'agents pharmaceutiques hypotenseurs (diurétiques, antagonistes de calcium, inhibiteurs de l'enzyme de conversion de l'angiotensine ou antagonistes de récepteurs d'angiotensine II), d'analgésiques non-stéroïdiques, d'antidépresseurs (lithium), de méthylxanthines (théophylline), de biguanides (métformine), ou d'hypolipidémiants (fibrates, échangeurs d'anions, acide nicotinique et analogues d'acide nicotinique).
PCT/EP2000/008801 2000-02-03 2000-09-08 Composition pharmaceutique destinee au traitement d'une hyperhomocysteinemie provoquee par un medicament Ceased WO2001056609A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2000272858A AU2000272858A1 (en) 2000-02-03 2000-09-08 Pharmaceutical composition for treating hyperhomocysteinaemia caused by medicaments

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10004651A DE10004651A1 (de) 2000-02-03 2000-02-03 Kombination von blutdrucksenkenden Wirkstoffen mit Wirkstoffen, die den Homocysteinspiegel zu senken vermögen
DE10004651.7 2000-02-03

Publications (1)

Publication Number Publication Date
WO2001056609A1 true WO2001056609A1 (fr) 2001-08-09

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PCT/EP2000/008801 Ceased WO2001056609A1 (fr) 2000-02-03 2000-09-08 Composition pharmaceutique destinee au traitement d'une hyperhomocysteinemie provoquee par un medicament

Country Status (3)

Country Link
AU (1) AU2000272858A1 (fr)
DE (1) DE10004651A1 (fr)
WO (1) WO2001056609A1 (fr)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003045359A3 (fr) * 2001-11-26 2003-12-18 Astion Oncology Aps Combinaison de derives de cimetidine et de cysteine pour traiter le cancer
WO2005011642A1 (fr) * 2003-08-05 2005-02-10 Galephar M/F Composition pharmaceutique a unite simple comprenant un melange de fibranne et un agent reducteur d'homocysteine
EP1518554A1 (fr) * 2003-09-26 2005-03-30 Medosan Industrie Biochimiche Riunite S.r.l. Composition pharmaceutique pour le traitement de l'hyperhomocystéinémie
WO2005016228A3 (fr) * 2003-08-14 2005-05-19 Dpharm Ltd Compositions et procedes visant a reduire le risque d'epilepsie et/ou traiter des troubles convulsifs
WO2006005173A1 (fr) * 2004-07-09 2006-01-19 Medicure International Inc. Polytherapies utilisant des derives d'acide nicotinique et un pyridoxal-5'-phosphate ou un compose associe de pyridoxal-5'-phosphate
EP1681055A1 (fr) * 2005-01-13 2006-07-19 PEJO Iserlohn Heilmittel-und Diät-GmbH & Co.KG Préparation pharmaceutique pour le traitement des taux d'homocysteine elevés
WO2006086856A1 (fr) * 2005-02-15 2006-08-24 Messadek, Jallal Compositions therapeutiques combinees et leurs procedes d’utilisation
WO2008061456A1 (fr) * 2006-11-20 2008-05-29 Pficker Pharmaceuticals Ltd. Composé folacine-metformine et sa production
US7608640B2 (en) 1999-03-02 2009-10-27 Jallal Messadek Glycine betaine and its use
US7786077B2 (en) 2005-04-27 2010-08-31 Jallal Messadek Insulins combinations
US8101599B2 (en) 2002-05-17 2012-01-24 Novartis Ag Pharmaceutical composition containing anti-hypertensive agents
US8318805B2 (en) 2004-11-10 2012-11-27 Jallal Messadek Modulation of nitric oxide synthases by betaines
US8343947B2 (en) 2003-07-15 2013-01-01 Jallal Messadek Therapeutic treatment
CN103386130A (zh) * 2013-06-27 2013-11-13 深圳奥萨医药有限公司 Ace抑制剂/噻嗪类利尿剂/5-甲基四氢叶酸药物组合物及用途

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10016379B2 (en) 2015-10-30 2018-07-10 Robin L. Webb Method of treatment for third spacing

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US6008221A (en) * 1996-11-06 1999-12-28 Bristol-Myers Squibb Company Method for treating Alzheimer's disease with folic acid
AU2899099A (en) * 1998-03-06 1999-09-20 Charles L Brown Composition for treatment and prevention of coronary artery disease

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
A.K.AARSAND, S.M.CARLSEN: "Folate administration reduces circulating homocysteine levels in NIDDM patients on long-term metformin treatment", JOURNAL OF INTERNAL MEDICINE, vol. 244, no. 2, 1998, pages 169 - 174, XP000990675 *
A.VAN EDE E.A.: "Effect of folic and folinic acid suppletion on toxicity and efficacy of methotrexate in rheumatoid arthritis: a randomized,doubleblind 48 weel clinical trial", ARTHRITIS & RHEUMATISM ABSTRACT SUPPLEMENT, vol. 42, no. 9 suppl, 1999, pages S380, XP002163899 *
E.L.MAYER E.A.: "Homocysteine and coronary atherosclerosis", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, vol. 27, no. 3, 1996, pages 517 - 527, XP000990693 *
J.H.STEIN, P.E.MCBRIDE: "Hyperhomocysteinemia and atherosclerotic vascular disease", ARCHIVES OF INTERNAL MEDICINE, vol. 158, no. 12, 1998, pages 1301 - 1306, XP002163900 *
P.C.FALLEST-STROBL E.A.: "Homocysteine: A new risk factor for atherosclerosis", AMERICAN FAMILY PHYSICIAN, vol. 56, no. 6, 1997, pages 1602 - 1612, XP000990650 *
S.L.MORGAN E.A.: "Folic acid supplementation prevents deficient blood folate levels and hyperhomocysteinemia during longterm, low dose methotrexate therapy for rheumatoic arthritis: Implications for cardiovascular disease prevention", JOURNAL OF RHEUMATOLOGY, vol. 25, no. 3, 1998, pages 441 - 446, XP000990681 *
T.APELAND E.A.: "Plasma homocysteine concentrations in patients with epilepsy on carbamazepine monotherapy", EPILEPSIA, vol. 40, no. suppl 2, 1999, pages 280, XP000990677 *

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7608640B2 (en) 1999-03-02 2009-10-27 Jallal Messadek Glycine betaine and its use
WO2003045359A3 (fr) * 2001-11-26 2003-12-18 Astion Oncology Aps Combinaison de derives de cimetidine et de cysteine pour traiter le cancer
US8101599B2 (en) 2002-05-17 2012-01-24 Novartis Ag Pharmaceutical composition containing anti-hypertensive agents
US8343947B2 (en) 2003-07-15 2013-01-01 Jallal Messadek Therapeutic treatment
WO2005011642A1 (fr) * 2003-08-05 2005-02-10 Galephar M/F Composition pharmaceutique a unite simple comprenant un melange de fibranne et un agent reducteur d'homocysteine
US7745426B2 (en) 2003-08-14 2010-06-29 D-Pharm Ltd. Compositions and methods for reducing the risk of epileptic occurrence and/or for treatment of seizure disorders
WO2005016228A3 (fr) * 2003-08-14 2005-05-19 Dpharm Ltd Compositions et procedes visant a reduire le risque d'epilepsie et/ou traiter des troubles convulsifs
CN1867550B (zh) * 2003-08-14 2012-08-15 迪-药品有限公司 用于降低癫痫发生的危险和/或用于治疗癫痫发作疾病的组合物和方法
AU2004264744B2 (en) * 2003-08-14 2009-12-10 Advanced Neuroprotective Systems Ltd. Compositions and methods for reducing the risk of epileptic occurrence and/or for treatment of seizure disorders
EP1518554A1 (fr) * 2003-09-26 2005-03-30 Medosan Industrie Biochimiche Riunite S.r.l. Composition pharmaceutique pour le traitement de l'hyperhomocystéinémie
WO2006005173A1 (fr) * 2004-07-09 2006-01-19 Medicure International Inc. Polytherapies utilisant des derives d'acide nicotinique et un pyridoxal-5'-phosphate ou un compose associe de pyridoxal-5'-phosphate
US8318805B2 (en) 2004-11-10 2012-11-27 Jallal Messadek Modulation of nitric oxide synthases by betaines
EP1681055A1 (fr) * 2005-01-13 2006-07-19 PEJO Iserlohn Heilmittel-und Diät-GmbH & Co.KG Préparation pharmaceutique pour le traitement des taux d'homocysteine elevés
US7780990B2 (en) 2005-02-15 2010-08-24 Jallal Messadek Combination therapeutic compositions and method of use
WO2006086856A1 (fr) * 2005-02-15 2006-08-24 Messadek, Jallal Compositions therapeutiques combinees et leurs procedes d’utilisation
US7786077B2 (en) 2005-04-27 2010-08-31 Jallal Messadek Insulins combinations
WO2008061456A1 (fr) * 2006-11-20 2008-05-29 Pficker Pharmaceuticals Ltd. Composé folacine-metformine et sa production
US8329710B2 (en) 2006-11-20 2012-12-11 Sino-Us Pficker Pharmaceuticals Co. Metformin folate and preparation of the same
CN103386130A (zh) * 2013-06-27 2013-11-13 深圳奥萨医药有限公司 Ace抑制剂/噻嗪类利尿剂/5-甲基四氢叶酸药物组合物及用途

Also Published As

Publication number Publication date
AU2000272858A1 (en) 2001-08-14
DE10004651A1 (de) 2001-08-16

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