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WO1995024919A1 - Nouvelle utilisation d'hormones de croissance - Google Patents

Nouvelle utilisation d'hormones de croissance Download PDF

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Publication number
WO1995024919A1
WO1995024919A1 PCT/BE1995/000022 BE9500022W WO9524919A1 WO 1995024919 A1 WO1995024919 A1 WO 1995024919A1 BE 9500022 W BE9500022 W BE 9500022W WO 9524919 A1 WO9524919 A1 WO 9524919A1
Authority
WO
WIPO (PCT)
Prior art keywords
growth hormone
low
patient
level
dopamine
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/BE1995/000022
Other languages
English (en)
Inventor
Greta Herman Van Den Berghe
Francis Edouard De Zegher
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.)
Katholieke Universiteit Leuven
Original Assignee
Katholieke Universiteit Leuven
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
Priority claimed from NL9401045A external-priority patent/NL9401045A/nl
Application filed by Katholieke Universiteit Leuven filed Critical Katholieke Universiteit Leuven
Priority to AU19429/95A priority Critical patent/AU1942995A/en
Publication of WO1995024919A1 publication Critical patent/WO1995024919A1/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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin

Definitions

  • the present invention relates to a new use of growth hormone.
  • T3 triiodothyronine
  • the critically ill patient can be mentioned as another example of a patient with a low T3 syndrome.
  • This can be defined as a person who has undergone a major surgical operation or serious traumatic injury or is recovering therefrom, or is suffering from a serious illness and whose vital functions have to be supported by means of mechanical and/or pharmacological means, such as mechanical ventilation, extra corporeal cardiac support, renal replacement therapy, inotropic support etc..
  • Prolonged critical illness can be considered a state of chronic severe stress.
  • This stress can be generated by different factors such as sepsis, hypoxy of the tissues, multiple organ failure, infections, wound of healing, pain, fear, immobilization or even by the supporting measures and therapeutic medicines themselves.
  • This state of chronic stress appears to result in a complex of pathophysiological processes which ultimately result in a clinical picture characterized by a catabolic condition, a disturbed immune function and the generation of catecholamines and cytokines.
  • the catabolic condition limits in particular the capacity of the patient to take care of himself and this slows down recovery.
  • inotropic agents are currently available in intensive care medicine. Dopamine nevertheless remains the first choice supportive agents for many doctors because of its superior inotropic properties and the possible optimization of the intestinal and kidney perfusion. Dopamine is therefore used extensively in cases of critically ill, septic, post-operative or post-traumatic infants, toddlers, small children and older children as well as adults, this sometimes for days, weeks or even months.
  • the invention therefore relates to the use of growth hormone to manufacture a pharmaceutical preparation for treating patients with a low triiodothyronine level which is for instance the consequence of the low T3 syndrome.
  • This low T3 level can already be documented but the use may also be applicable to patients in whom a low T3 level is anticipated on the basis of the observed symptoms, without this being already determined. Treatment can already be started when a low T3 level is expected.
  • the treatment with growth hormone is of course not limited to the above described critically ill patient but is applicable to any mentally or physically ill patient whose disorder comprises a low T3 syndrome.
  • Understood by "low T3 level” is a level of total T3 in serum lying below the level of about 80 ng/dl qualified as normal.
  • Understood by "low T3 syndrome” is having a low T3 level in combination with a low or normal TSH (thyroid stimulating hormone) level. It is found in practice that the T3 level in sufferers of low T3 syndrome may even lie below 25 ng/dl.
  • both natural and recombinant growth hormone can in principle be used.
  • recombinant growth hormone will usually be used.
  • peptides or other molecules which stimu ⁇ late secretion of growth hormone can be applied, on their own or in combination with growth hormone. It will be appar ⁇ ent to the skilled person which peptides or other molecules are suitable for this purpose. It is important herein that the growth hormone secretion of the body is stimulated.
  • compositions which contain growth hormone as the active ingredient or which stimulate the endogenous production of growth hormone and which can be used for treating patients with a low T3 level in the serum will be administered by enteral means, intravenously, subcutaneously or intramuscularly.
  • the pharmaceutical compositions according to the invention can take the form of oral forms of medication such as solutions, suspensions, emulsions, powders, capsules or tablets, or injectable forms of medication.
  • the compositions can be prepared by combining (e.g. mixing, dissolving etc.) the active compound with pharmaceutically acceptable diluents of a neutral character (such as aqueous or non-aqueous solvents, stabilizers, emulsifiers, detergents, additives etc.), and further with colouring agents if necessary.
  • a neutral character such as aqueous or non-aqueous solvents, stabilizers, emulsifiers, detergents, additives etc.
  • the concentration of the active ingredient in a therapeutic composition can vary between 0.1 and 100% depending on the specific situation and the method of administration.
  • the dose of the active ingredient that is administered can further vary between 0.05 IU and 1.0 IU per kg body weight (this corresponds roughly with 0.03-0.56 ng/kg) .
  • Clinical tests with patients who had undergone a lung transplant or a heart-lung transplant and who as a result were being nursed in the intensive care unit have shown that the administering of growth hormone was accompanied by the recovery of the patients.
  • Dopaminergic medicines which directly or indirectly cause a low T3 level are dopamine, dopamine-agonists such as bromocryptine, cabergoline, epinine etc., dopamine precursors and precursors of dopamine-agonists such as ibopamine.
  • dopamine-agonists are compounds which have an activity corresponding with dopamine.
  • dopamine-precursors are compounds which are converted in the body or otherwise into dopamine.
  • precursors of dopamine-agonists are substances which are converted in the body or otherwise into a dopamine- agonist.
  • the invention further relates to pharmaceutical compositions which contain one or more thyroid hormones in addition to the growth hormone and a pharmacologically acceptable diluent.
  • a combination of growth hormone with anabolic steroids optionally supplemented with thyroid hormones.
  • thyroid hormones are triiodothyronine (T3) and thyroxine (T4) .
  • T3 triiodothyronine
  • T4 thyroxine
  • Addition of thyroid hormones can immediately obviate a deficiency in this area.
  • Anabolic steroids provide a reversal of the catabolic condition.
  • the action of the growth hormone is additionally supported in such "cock ⁇ tails". Examples of such anabolic steroids are androgens, oestrogens and their natural or synthetic analogues.
  • GH growth hormone
  • Heart, heart-lung and lung transplants are now being performed to an increasing extent on patients with a terminal disease of these organs.
  • the nutritional condition prior to the operation is often poor, the stress after the operation is normally extreme and high doses of glucocorticoids are administered as part of the immune suppression.
  • glucocorticoids are administered as part of the immune suppression.
  • Such patients run a high risk of developing a serious catabolic condition which could in turn have a further adverse effect on post-operative progress.
  • the growth hormone concentrations in the serum prior to the therapy were lower than 5 ⁇ lU/ml ( 2.8 ⁇ g/1 (ng/ml) ) .
  • BUN levels urea-nitrogen levels in blood
  • Patient 1 received growth hormone for three weeks, while patients 2 and 3 were treated for two weeks. Within respectively 11, 7 and 5 days the condition of the patients was noticeably improved, they were successfully withdrawn from the respirators and the ventilation was finally terminated.
  • the IGF-1 and insulin concentration in the serum increased at least fourfold.
  • the rise in insulin concentration was partly of exogenous origin, since due to an increased glucose intolerance continuous infusion of human insulin had become necessary.
  • the insulin dose was adjusted such that a blood glucose concentration of about 5.6 mmol/1 was obtained.
  • the glucose intolerance disappeared within 24 hours after the growth hormone therapy was interrupted.
  • the T3 concentrations in serum were found to have risen by roughly 50%.
  • the creatinine removal which is a measure for the glomerular filtration speed as a measure for the kidney function, rose in patient 1 from 18.2 to 32 ml/min and decreased in patients 2 and 3 from respectively 62 to 32 ml/min and from 108 to 70 ml/min. In all three patients the creatine removal thereafter remained stable. Because fluid was retained the body weight increased quickly during the first few days to a maximum of respectively 20%, 16% and 11% above the weight before the treatment. The maximum fluid retained appeared at the be- ginning of the second week of the growth hormone medication. By administering diuretics (furosemide) retention of fluid decreased with continued growth hormone therapy.
  • the three patients presented here were in a clinical condition of catabolism considered hopeless and dependent on ventilation after a heart-lung or double lung transplant.
  • the biochemical parameters confirm the clinical impression of the catabolic condition (high levels of BUN, low levels of IGF-l, insulin and T3) before the growth hormone therapy was started. All patients displayed an exceptionally rapid recovery, both clinically and biochemically, during the growth hormone therapy.
  • Vasculitis probably on autoimmune basis, was diagnosed in a male patient of 52 years of age. Accompanying symptoms were bulbous ulcer and arterial bleeding, secondary intestinal necrosis, fistulization and wound healing problems. The patient had undergone extensive and repeated surgical operations, such as progressive intestinal section resulting in "short bowel syndrome", combined with a high dose glucocorticoids treatment. In addition the patient displayed a low T3 syndrome, characterized by a TSH level of 0.01 mIU/1; a T4 level of 6.5 ⁇ g/dl; a T3 level of 49 ng/dl and a reverse T3 level of 155 ng/dl. Because no wound healing occurred and pronounced muscular atrophy and cachexia were observed, the patient was dependent upon ventilation.
  • the patient was treated post-operatively with growth hormone and T4 for 42 days after the first extensive surgical treatment.
  • the total duration of the treatment amounted to 54 days, whereafter the patient was discharged from the intensive care unit and was further cared for in abdominal medicine.
  • On days 1 and 2 4IU of growth hormone were administered, on days 3-7 8 IU and on days 8-54 16 IU.
  • On days 1 to 14 50 ⁇ g T4 was administered, thereafter 100 ⁇ g/day.
  • the wound healing evolved from a completely atonal, open abdominal wound without any sign of scar tissue forming and even totally without fibrin formation, with persistent fistulization and bile leakage, to a very rapidly granulating wound with closure of fistulas and healing of the bile leak.
  • Table 1 below gives a survey of the IGF-l values (in ng/ml) and the urea content in blood (mg/dl) of the patient.
  • a serum IGF-l increase and a serum urea decrease are together considered signs of anabolism.
  • a graphic representation of these results is shown in figure 2. This shows that the IGF-l level rose during the treatment. In this specific patient the urea content in the blood was always low while a pronounced catabolism was nevertheless present. This can be explained by a substantial amount of nitrogen loss abdominally via the enterocutaneous fistulas.
  • a female patient of 56 years of age was suffering from a sigmoid perforation on diverticulitis with faecal peritonitis and sepsis with multiple organ system failure. As a result she was being ventilated and subjected to continuous veno-venous haemofiltration as kidney replacement therapy. She displayed in addition low T3 syndrome.
  • the low T3 syndrome is characterized by the following contents of thyroid hormones: TSH is 3.5 mIU/1; T4 is 2.9 ⁇ g/dl; T3 is 36 ng/dl.
  • TSH is 3.5 mIU/1
  • T4 is 2.9 ⁇ g/dl
  • T3 is 36 ng/dl.
  • the patient was admitted to the intensive care unit after a secondary referral from a peripheral hospital because of her low T3 syndrome, drowsiness, pronounced cachexia and her dependance upon respiration equipment.
  • the IGF-l and urea values were determined in blood by standard procedures. The results are given in table 2 below and are shown graphically in figure 3. The IGF-l values increased while the urea level decreased, indicating anabolism.
  • IGF-l values (ng/ml) urea content (mg/dl) day 0 64.5 104 day 3 93.8 75 day 6 157.3 70 day 11 208.2 64 day 15 227 63 day 22 n.d. 81 day 29 n.d. 51
  • TSH thyroid hormones
  • the pleural effusions decreased slightly with administering of only T4. They only disappeared completely after combination therapy of T4 + growth hormone. Her peripheral muscular strength clearly increased, but only after the growth hormone therapy was started. In all other respects the patient experienced a surprisingly speedy recovery, which resulted in an early discharge from the intensive care unit. The growth hormone treatment was therefore also terminated prematurely.
  • IGF-l and urea values were determined in blood by standard procedures. The results are given in table 3 below and are shown graphically in figure 4.
  • IGF-l values (ng/ml) urea content (mg/dl) day -13 103 150 before starting T4 day -7 n.d. 82 after 7 days T4 day 1 55 56 day 3 60 54 day 8 71 33
  • TSH 1 mIU/1
  • T4 2 ⁇ g/dl
  • T3 40 ng/dl
  • reverse T3 24 ng/dl. This indicates a pronouncedly low T3 syndrome.
  • the patient was in a catabolic condition and was dependant upon artificial respiration equipment.
  • the wound healing of the patient clearly improved under the growth hormone therapy.
  • the ventilation had already been stopped by the time the growth hormone therapy started.
  • the peripheral muscular strength very clearly increased, which was shown by means of a kinesitherapeutic evaluation (results not shown) .
  • Table 4 shows a survey of the urea levels in the patient. The values are shown graphically in figure 4. The urea content clearly decreased, which signifies an improvement in the catabolic condition. Table 4
  • the growth hormone therapy was started to stimulate the immunity of the patient and increase the chance of recovery from these extremely infectious injuries. On days 1 and 2 4 IU of growth hormone was administered, on days 3-5 a dose of 8 IU and on days 6-34 a dose of 16 IU. In addition the patient continuously received 25 ⁇ g T3 a day intravenously. 6.3 Evaluation
  • IGF-l values (ng/ml) urea content (mg/dl) day 1 129 23. day 3 402 21 day 6 385 27 day 8 520 24 day 13 755 33 day 20 543 39 day 27 674 32 day 34 618 33
  • the values are shown graphically in figure 5.
  • the IGF-l values clearly increased while the urea content remained consistently low under an increased supply of proteins.
  • the thyroid hormone contents were as follows: TSH is 0.1 mIU/1; T4 is 2 ⁇ g/dl; T3 is 28 ng/dl.
  • the patient was treated with growth hormone and T3.
  • Growth hormone was administered in a quantity of 4 IU on days 1 and 2, 8 IU on days 3-5, 16 IU on days 6-21, 8 IU on days 22-32 and 16 IU on days 33-84.
  • T3 was administered by means of an infusion in a quantity of 25 ⁇ g/day.
  • Rinses of the right hemithorax were performed daily and a well granulating wound resulted progressively.
  • a revision was performed because of a small leak in the right bronchus stump, for which an omentumplasty was performed.
  • the wound healed perfectly and the right bronchus was definitively closed.
  • the patient was ventilated with a high frequency percussion respiration device (on days 1-7) . It was possible thereafter to transfer to conventional ventilation (SIMV ASB) .
  • the pressure support could be reduced from day 37 but could not be withdrawn completely until after the revision of the bronchus leak was carried out on day 52.
  • SIMV ASB conventional ventilation
  • IGF-l values urea content T3 (ng/ml) (mg/dl) (ng/dl) day 0 127 199 28 day 34 164 189 83 day 41 312 106 95 day 49 341 69 n.d. day 54 398 92 105 day 61 258 98 91 day 68 413 80 129 day 75 579 78 150
  • the present invention it is possible to withdraw from the support equipment quicker and more often than until now patients with a low T3 level, who have to be artificially ventilated or otherwise require supportive therapy.
  • the growth hormone therapy has a positive effect on a large number of other body functions, such as wound healing, muscular strength, neurological functions and psychological well-being.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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Abstract

Nouvelle utilisation d'hormones de croissance, par exemple d'hormones de croissance recombinées et de préférence humaines, dans la fabrication d'une préparation pharmaceutique destinée au traitement des malades souffrant d'un faible taux de triiodothyronine. Un faible taux de triiodothyronine peut résulter du syndrome du faible taux de T3 tel que décrit dans la littérature. Le syndrome du faible taux de T3 chez un malade peut être dû à différentes affections cliniques tant physiques que mentales. La consommation de médicaments peut également entraîner le syndrome du faible taux de T3. Selon l'invention, on peut administrer au moins une hormone thyroïdienne et/ou au moins un stéroïde anabolisant en même temps que l'hormone de croissance.
PCT/BE1995/000022 1994-03-15 1995-03-15 Nouvelle utilisation d'hormones de croissance Ceased WO1995024919A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU19429/95A AU1942995A (en) 1994-03-15 1995-03-15 New use of growth hormone

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP94200661 1994-03-15
EP94200661.0 1994-03-15
NL9401045 1994-06-24
NL9401045A NL9401045A (nl) 1994-03-15 1994-06-24 Nieuw gebruik van groeihormoon.

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998001152A1 (fr) 1996-07-10 1998-01-15 Sumitomo Pharmaceuticals Company, Limited Medicaments pour les troubles alimentaires
WO2003092725A1 (fr) * 2002-05-03 2003-11-13 Metabolic Pharmaceuticals Limited Procede permettant de maitriser la depression a l'aide d'un fragment d'hormone de croissance (gh) a terminaison c
WO2004026330A1 (fr) * 2002-09-23 2004-04-01 K.U. Leuven Research And Development Methodes et preparations permettant de soigner des patients en phase critique
EP1806131A3 (fr) * 1996-07-22 2007-08-01 Renovo Limited Utilisation de modulateurs de la fonction stéroïde sexuelle pour traiter des plaies et des troubles fibrogènes
US7514419B2 (en) 2003-11-19 2009-04-07 Metabasis Therapeutics, Inc. Phosphorus-containing thyromimetics
US10130643B2 (en) 2005-05-26 2018-11-20 Metabasis Therapeutics, Inc. Thyromimetics for the treatment of fatty liver diseases
US11202789B2 (en) 2016-11-21 2021-12-21 Viking Therapeutics, Inc. Method of treating glycogen storage disease
US20230157982A1 (en) * 2020-04-21 2023-05-25 Ioulia Tseti Pharmaceutical composition comprising l-triiodothyronine (t3) for use in the treatment of tissue hypoxia and sepsis
US11707472B2 (en) 2017-06-05 2023-07-25 Viking Therapeutics, Inc. Compositions for the treatment of fibrosis
US11787828B2 (en) 2018-03-22 2023-10-17 Viking Therapeutics, Inc. Crystalline forms and methods of producing crystalline forms of a compound
US12102646B2 (en) 2018-12-05 2024-10-01 Viking Therapeutics, Inc. Compositions for the treatment of fibrosis and inflammation

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990009189A1 (fr) * 1989-02-07 1990-08-23 Brigham And Women's Hospital Traitement du dysfonctionnement pulmonaire et de la dependance vis-a-vis d'un ventilateur a l'aide d'une hormone de croissance
WO1991011196A1 (fr) * 1990-02-02 1991-08-08 Novo Nordisk A/S Procede de traitement pour mammiferes utilisant un compose biologiquement actif
WO1993004694A1 (fr) * 1991-09-05 1993-03-18 Novo Nordisk A/S Methode de traitement des malades atteints de maladies de foie chroniques
WO1995000167A1 (fr) * 1993-06-25 1995-01-05 Pharmacia Ab Utilisation de l'hormone de croissance humaine en administration preoperatoire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990009189A1 (fr) * 1989-02-07 1990-08-23 Brigham And Women's Hospital Traitement du dysfonctionnement pulmonaire et de la dependance vis-a-vis d'un ventilateur a l'aide d'une hormone de croissance
WO1991011196A1 (fr) * 1990-02-02 1991-08-08 Novo Nordisk A/S Procede de traitement pour mammiferes utilisant un compose biologiquement actif
WO1993004694A1 (fr) * 1991-09-05 1993-03-18 Novo Nordisk A/S Methode de traitement des malades atteints de maladies de foie chroniques
WO1995000167A1 (fr) * 1993-06-25 1995-01-05 Pharmacia Ab Utilisation de l'hormone de croissance humaine en administration preoperatoire

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998001152A1 (fr) 1996-07-10 1998-01-15 Sumitomo Pharmaceuticals Company, Limited Medicaments pour les troubles alimentaires
EP0916345A4 (fr) * 1996-07-10 2008-08-06 Dainippon Sumitomo Pharma Co Medicaments pour les troubles alimentaires
EP1806131A3 (fr) * 1996-07-22 2007-08-01 Renovo Limited Utilisation de modulateurs de la fonction stéroïde sexuelle pour traiter des plaies et des troubles fibrogènes
WO2003092725A1 (fr) * 2002-05-03 2003-11-13 Metabolic Pharmaceuticals Limited Procede permettant de maitriser la depression a l'aide d'un fragment d'hormone de croissance (gh) a terminaison c
WO2004026330A1 (fr) * 2002-09-23 2004-04-01 K.U. Leuven Research And Development Methodes et preparations permettant de soigner des patients en phase critique
US7514419B2 (en) 2003-11-19 2009-04-07 Metabasis Therapeutics, Inc. Phosphorus-containing thyromimetics
US7829552B2 (en) 2003-11-19 2010-11-09 Metabasis Therapeutics, Inc. Phosphorus-containing thyromimetics
US10925885B2 (en) 2005-05-26 2021-02-23 Metabasis Therapeutics, Inc. Thyromimetics for the treatment of fatty liver diseases
US10130643B2 (en) 2005-05-26 2018-11-20 Metabasis Therapeutics, Inc. Thyromimetics for the treatment of fatty liver diseases
US11202789B2 (en) 2016-11-21 2021-12-21 Viking Therapeutics, Inc. Method of treating glycogen storage disease
US11707472B2 (en) 2017-06-05 2023-07-25 Viking Therapeutics, Inc. Compositions for the treatment of fibrosis
US11787828B2 (en) 2018-03-22 2023-10-17 Viking Therapeutics, Inc. Crystalline forms and methods of producing crystalline forms of a compound
US12227533B2 (en) 2018-03-22 2025-02-18 Viking Therapeutics, Inc. Crystalline forms and methods of producing crystalline forms of a compound
US12102646B2 (en) 2018-12-05 2024-10-01 Viking Therapeutics, Inc. Compositions for the treatment of fibrosis and inflammation
US20230157982A1 (en) * 2020-04-21 2023-05-25 Ioulia Tseti Pharmaceutical composition comprising l-triiodothyronine (t3) for use in the treatment of tissue hypoxia and sepsis
JP2023538984A (ja) * 2020-04-21 2023-09-13 ユニファーマ クレオン ツェティス ファーマスーティカル ラボラトリーズ エス エー 組織低酸素症及び敗血症の治療に使用するためのｌ－トリヨードチロニン（ｔ３）を含む医薬組成物

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