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WO1998030217A1 - Complement destine a des patients sous dialyse - Google Patents

Complement destine a des patients sous dialyse Download PDF

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Publication number
WO1998030217A1
WO1998030217A1 PCT/US1998/000014 US9800014W WO9830217A1 WO 1998030217 A1 WO1998030217 A1 WO 1998030217A1 US 9800014 W US9800014 W US 9800014W WO 9830217 A1 WO9830217 A1 WO 9830217A1
Authority
WO
WIPO (PCT)
Prior art keywords
dialysis
patients
amino acids
tablet
patient
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/US1998/000014
Other languages
English (en)
Inventor
Mackenzie Walser
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to AU58135/98A priority Critical patent/AU5813598A/en
Priority to PCT/US1998/003815 priority patent/WO1999034813A1/fr
Priority to CA002317038A priority patent/CA2317038C/fr
Priority to DE69839922T priority patent/DE69839922D1/de
Priority to AU68633/98A priority patent/AU751556B2/en
Priority to AT98914229T priority patent/ATE405287T1/de
Priority to PT98914229T priority patent/PT1044017E/pt
Priority to JP2000527261A priority patent/JP2002500191A/ja
Priority to TR2000/01896T priority patent/TR200001896T2/xx
Priority to EP98914229A priority patent/EP1044017B1/fr
Priority to DK98914229T priority patent/DK1044017T3/da
Priority to ES98914229T priority patent/ES2311297T3/es
Publication of WO1998030217A1 publication Critical patent/WO1998030217A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids

Definitions

  • the invention relates to an amino acid supplement for dialysis patients. Patients on dialysis in the U.S. exhibit. a 24% mortality per year. The best predictor of mortality identified to date is the serum albumin concentration.
  • Intravenous supplementation has been studied more extensively, but the expense of this treatment is prohibitive, and according to Wolfson (9) , ". . . there are numerous flaws in many of these studies" .
  • Furst et al . (11) designed a new formula of essential amino acids, with a higher proportion of valine, lower proportions of leucine and isoleucine, and the inclusion of tyrosine, in an attempt to correct the extracellular and intracellular abnormalities of amino acid concentration that they found in pre- dialysis uremic patients. They have shown that this mixture maintains nitrogen balance while improving abnormalities of amino acid concentrations (11 - 14) .
  • This formula was also used in the Feasibility Phase of a large NIH-supported study entitled "Modification of Diet in Renal Disease", and was found to maintain nutrition in these patients with advanced chronic renal failure (15) . This mixture has neither been used nor advocated in patients on dialysis.
  • the invention is based on the concept that a mixture of amino acids in tablet form and comprising, in each tablet, L-histidine 45 mg, L-isoleucine 60 mg, L-leucine 90 mg, L-lysine 65 mg, L-methionine 90 mg, L- phenylalanine 70 mg, L-tryptophan 25 mg, L-tyrosine 75 mg, and L-valine 135 mg, administered in a dose of 8 to 18 tablets per day, will prevent and/or correct hypoalbuminemia in patients on dialysis (either hemodialysis or peritoneal dialysis) , and will therefore improve their survival .
  • a group of hypoalbuminemic dialysis patients is randomized to receive either these tablets (14 per day) or a similar placebo for three months, in a double-blind fashion, with no change in their diet. Randomization is stratified for two ranges of serum albumin concentration (low and very low) and for hemodialysis vs. peritoneal dialysis. Before supplementation and at monthly intervals during supplementation, serum albumin, anthropometry, and serum amino acid levels are measured. Patients receiving the amino acid supplement should exhibit a greater rise in serum albumin concentration than patients receiving the placebo. Since serum albumin concentration is the best predictor of mortality, patients receiving the amino acid supplement are also anticipated to exhibit lower mortality.
  • the invention contemplates variations in the amounts of amino acids from those recited above. Typically the variation can be in the order of 10 - 30% by weight. However, it is preferred that the indicated ratios of the amino acids be maintained. Thus, for example, the amounts of L- leucine and L-methionine should be about twice the amount of L-histidine administered while the amount of L-isoleucine should be about two-thirds of the L- leucine and L-methionine.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne l'utilisation d'un complément alimentaire sous forme de comprimé, destiné à être administré à un patient sous dialyse, comprenant un mélange des substances suivantes: L-histidine, L-isoleucine, L-leucine, L-lysine, L-méthionine, L-phénylalanine, L-tryptophane, L-tyrosine et L-valine, et destiné à prévenir et/ou corriger l'hypoalbuminémie chez un patient sous dialyse.
PCT/US1998/000014 1997-01-06 1998-01-05 Complement destine a des patients sous dialyse Ceased WO1998030217A1 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
AU58135/98A AU5813598A (en) 1997-01-06 1998-01-05 Supplement for dialysis patients
PCT/US1998/003815 WO1999034813A1 (fr) 1998-01-05 1998-03-13 Supplement dietetique pour patients dialyses
CA002317038A CA2317038C (fr) 1998-01-05 1998-03-13 Supplement dietetique pour patients dialyses
DE69839922T DE69839922D1 (de) 1998-01-05 1998-03-13 Diätetische ergänzung für dialyse patienten
AU68633/98A AU751556B2 (en) 1998-01-05 1998-03-13 Supplement for dialysis patients
AT98914229T ATE405287T1 (de) 1998-01-05 1998-03-13 Diätetische ergänzung für dialyse patienten
PT98914229T PT1044017E (pt) 1998-01-05 1998-03-13 Suplemento para doentes em diálise
JP2000527261A JP2002500191A (ja) 1998-01-05 1998-03-13 透析患者のための補助剤
TR2000/01896T TR200001896T2 (tr) 1998-01-05 1998-03-13 Diyaliz hastaları için takviye maddesi.
EP98914229A EP1044017B1 (fr) 1998-01-05 1998-03-13 Supplement dietetique pour patients dialyses
DK98914229T DK1044017T3 (da) 1998-01-05 1998-03-13 Kosttilskud til dialysepatienter
ES98914229T ES2311297T3 (es) 1998-01-05 1998-03-13 Complemento para pacientes en dialisis.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3423397P 1997-01-06 1997-01-06
US60/034,233 1997-01-06

Publications (1)

Publication Number Publication Date
WO1998030217A1 true WO1998030217A1 (fr) 1998-07-16

Family

ID=21875118

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/000014 Ceased WO1998030217A1 (fr) 1997-01-06 1998-01-05 Complement destine a des patients sous dialyse

Country Status (2)

Country Link
AU (1) AU5813598A (fr)
WO (1) WO1998030217A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4100160A (en) * 1974-04-15 1978-07-11 The Johns Hopkins University Therapeutic compositions comprising alpha-hydroxy analogs of essential amino acids and their administration to humans for promotion of protein synthesis and suppression of urea formation
US4357343A (en) * 1981-06-26 1982-11-02 Baxter Travenol Laboratories, Inc. Nutritional composition for management of renal failure
US5480865A (en) * 1994-02-25 1996-01-02 Parkinson's Charitable Trust Nutritional composition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4100160A (en) * 1974-04-15 1978-07-11 The Johns Hopkins University Therapeutic compositions comprising alpha-hydroxy analogs of essential amino acids and their administration to humans for promotion of protein synthesis and suppression of urea formation
US4357343A (en) * 1981-06-26 1982-11-02 Baxter Travenol Laboratories, Inc. Nutritional composition for management of renal failure
US5480865A (en) * 1994-02-25 1996-01-02 Parkinson's Charitable Trust Nutritional composition

Also Published As

Publication number Publication date
AU5813598A (en) 1998-08-03

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