WO1998024452A1 - Utilisation d'oxandrolone dans le traitement du syndrome de la fatigue chronique - Google Patents

Utilisation d'oxandrolone dans le traitement du syndrome de la fatigue chronique Download PDF

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Publication number
WO1998024452A1
WO1998024452A1 PCT/US1997/022336 US9722336W WO9824452A1 WO 1998024452 A1 WO1998024452 A1 WO 1998024452A1 US 9722336 W US9722336 W US 9722336W WO 9824452 A1 WO9824452 A1 WO 9824452A1
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WO
WIPO (PCT)
Prior art keywords
oxandrolone
chronic fatigue
fatigue syndrome
patient
treatment
Prior art date
Application number
PCT/US1997/022336
Other languages
English (en)
Inventor
Jon D. Kaiser
Original Assignee
Kaiser Jon D
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 Kaiser Jon D filed Critical Kaiser Jon D
Priority to AU53748/98A priority Critical patent/AU5374898A/en
Publication of WO1998024452A1 publication Critical patent/WO1998024452A1/fr

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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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin

Definitions

  • CFS Chronic Fatigue Syndrome
  • CFS CFS may be due to stress and it may also have a psychological component. Chronic fatigue syndrome may have different causes in different people, i.e. different etiology.
  • CFS Chronic Fatigue and Immune Dysfunction Syndrome
  • Oxandrolone (17-methyl-17-hydroxy-2-oxa-5-androstan-3-one) is a known compound which is commercially available. The preparation of oxandrolone is described, inter alia, in U.S. Patent No. 3,128,283.
  • Oxandrolone is an anabolic steroid synthetically derived from testosterone. Oxandrolone has a unique chemical structure compared with other testosterone analogs. Oxandrolone contains an oxygen rather than a carbon atom at the 2-position within the phenanthrene nucleus (2) and lacks a 4-ene function in the A-ring. The anabolic activity of oxandrolone is approximately 6 times greater than its androgenic activity and has been found to be 6.3 times greater than that of methyltestosterone (2).
  • Anabolic activity refers to the ability to cause nitrogen retention, promoting weight gain and increasing muscle strength.
  • Androgenic activity refers to the ability to enhance male characteristics (i.e. secondary sex characteristics such as facial hairs and voice changes) . Because of the high ratio of anabolic to androgenic activity, oxandrolone is less likely to cause adverse cosmetic consequences in women than many testosterone analogs .
  • oxandrolone undergoes relatively little hepatic metabolism (3, 4).
  • Oxandrolone has been administered to malnourished patients with alcoholic hepatitis (5, 6) . Oxandrolone has been shown to be safe even in dosages of up to 80 mg/day in patients with alcoholic hepatitis (5) .
  • the subject invention discloses the use of an oxandrolone in the treatment of chronic fatigue syndrome. Summary of the Invention
  • the subject invention provides a method of treating chronic fatigue syndrome in a patient suffering from chronic fatigue syndrome which comprises administering an oxandrolone to the patient .
  • Oxandrolone as used herein encompasses 17-methyl-17-hydroxy- 2-oxa-5-androstan-3-one (both racemic mixtures and optically active enantiomers) as well as pharmaceutically acceptable esters thereof.
  • an oxandrolone product which is commercially available is the Oxandrin" tablet from BTG Pharmaceuticals Corp., Iselin, NJ 08830, which is 17a*- methyl-17/3-hydroxy-2-oxa-5 ⁇ -androstan-3-one. This product was used throughout the studies described herein.
  • Oxandrolone may be administered orally, intravenously, intramuscularly, subcutaneously, topically, intratracheally, intrathecally, intraperitoneally, rectally, vaginally or intrapleurally.
  • oxandrolone is administered orally, it is administered in the form of a tablet, a pill, a liquid or a capsule.
  • a liquid may be administered in the form of a solution or a suspension.
  • compositions produced in accordance with the invention may comprise conventional pharmaceutically acceptable diluents or carriers.
  • Tablets, pills, liquids and capsules may include conventional excipients such as lactose, starch, cellulose derivatives, hydroxypropyl methylcellulose and magnesium stearate.
  • Suppositories may include excipients such as waxes and glycerol.
  • injectable solutions will comprise sterile pyrogen-free media such as saline and may include buffering agents, stabilizing agents, solubilizing agents or preservatives. Conventional enteric coatings may also be used.
  • compositions for topical administration may be in the form of creams, ointments, lotions, solutions, transdermal delivery systems, transdermal patches or gels.
  • Oxandrolone may be administered in a solid dosage form, in a liquid dosage form, in a sustained-release formulation or in a once a day formulation.
  • the liquid dosage form may inter alia be alcohol-based or formulated with a cyclodextrin such as hydroxypropyl- -cyclodextrin.
  • the subject invention provides a method of treating chronic fatigue syndrome in a patient suffering from chronic fatigue syndrome which comprises administering a therapeutically effective amount of an oxandrolone to the patient.
  • the subject invention also provides a method of treating a symptom associated with chronic fatigue syndrome i a patient suffering from chronic fatigue syndrome which comprises administering a therapeutically effective amount of an oxandrolone to the patient.
  • the amount of the oxandrolone is about 1-100 mg per day.
  • the amount of the oxandrolone is about 5-20 mg per day.
  • the subject invention further provides a use of an oxandrolone in the preparation of a composition to treat chronic fatigue syndrome.
  • Interferon as used herein encompasses any interferon such as alpha-interferon, beta-interferon or gamma-interferon.
  • Corticosteroid as used herein encompasses inter alia glucocorticoids, mineralcorticoids and androgens.
  • glucocorticoids are hydrocortisone, cortisone, corticosterone and synthetic analogs of hydrocortisone and cortisone (such as cortisol, prednisolone and prednisone) .
  • mineralcorticoids are aldosterone and desoxycorticosterone.
  • Examples of androgens are DHEA, andros t enedione , testosterone and 11/3- hydroxyandrostenedione .
  • the oxandrolone may be administered in conjunction with a corticosteroid, an interferon or any known anti-inflammatory agent .
  • Oxandrolone may also be administered in conjunction with glutamine or human growth hormone.
  • Oxandrolone may also be administered in conjunction with nutritional counseling and exercise.
  • EXAMPLE 1 The Effect of Oxandrolone in the Treatment of Patients Suffering from Chronic Fatigue Syndrome
  • Women are treated with 2.5mg twice a day and men with 5mg twice a day, and the dosage is increased as necessary, up to 20mg per day (i.e. lOmg twice a day) .
  • Oxandrolone caused an improvement in the condition of CFS patients.
  • the criteria for measuring this improvement are based on subjective reporting from the patients who felt better, had more energy, could do more and spend less time in bed during the daytime.
  • a quality of life questionnaire showed improved quality of life in these patients which also demonstrates the efficacy of oxandrolone as a treatment in CFS patients.
  • Protocol 0.6 grams/lb protein (20% of total calories) protein supplement
  • J.E. 35 year old single white female. J.E. has a 14 year old history of CFIDS with severe fatigue dating back to acute viral illness in 1983, anxiety, depression, chronic HA's, intermittent ulcerative procitis, mitral valve prolapse and other symptoms.
  • Protocol 80 grams protein/day (60% of body weight) 15 minutes PRE's 4x/wk Oxandrin 5 mg bid
  • R.R. has a 17 year history of chronic fatigue and mild depression. His energy level was improved by antidepressants but he was unable to tolerate them for any extended period of time secondary to insomnia.
  • R.R. was also unable to tolerate Oxandrin R secondary to insomnia.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne un procédé de traitement du syndrome de la fatigue chronique, chez un patient souffrant d'un tel syndrome, ce procédé consistant à administrer à ce patient une oxandrolone.
PCT/US1997/022336 1996-12-05 1997-12-05 Utilisation d'oxandrolone dans le traitement du syndrome de la fatigue chronique WO1998024452A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU53748/98A AU5374898A (en) 1996-12-05 1997-12-05 The use of oxandrolone in the treatment of chronic fatigue syndrome

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3241896P 1996-12-05 1996-12-05
US60/032,418 1996-12-05

Publications (1)

Publication Number Publication Date
WO1998024452A1 true WO1998024452A1 (fr) 1998-06-11

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/022336 WO1998024452A1 (fr) 1996-12-05 1997-12-05 Utilisation d'oxandrolone dans le traitement du syndrome de la fatigue chronique

Country Status (2)

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AU (1) AU5374898A (fr)
WO (1) WO1998024452A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6489270B1 (en) 1999-01-07 2002-12-03 Daniel P. Vollmer Methods for enhancing wellbore treatment fluids
US6787659B2 (en) * 2001-12-11 2004-09-07 Barr Laboratories, Inc. Process for the production of oxandrolone

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5340586A (en) * 1991-04-12 1994-08-23 University Of Southern California Methods and formulations for use in treating oophorectomized women

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5340586A (en) * 1991-04-12 1994-08-23 University Of Southern California Methods and formulations for use in treating oophorectomized women

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6489270B1 (en) 1999-01-07 2002-12-03 Daniel P. Vollmer Methods for enhancing wellbore treatment fluids
US6787659B2 (en) * 2001-12-11 2004-09-07 Barr Laboratories, Inc. Process for the production of oxandrolone
US7009063B2 (en) 2001-12-11 2006-03-07 Barr Laboratories, Inc. Process for the production of oxandrolone

Also Published As

Publication number Publication date
AU5374898A (en) 1998-06-29

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