WO2001022991A1

WO2001022991A1 - Acth treatment of steroid- and statin-treated patients

Info

Publication number: WO2001022991A1
Application number: PCT/SE2000/001880
Authority: WO
Inventors: Anna-Lena Berg; Margret Arnadottir
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-09-29
Filing date: 2000-09-29
Publication date: 2001-04-05
Anticipated expiration: 2002-03-29
Also published as: AU7697500A

Abstract

A method of treating a patient who is on therapy with steroids and statins is disclosed. The method includes administering to said patient a therapeutically effective amount of a composition comprising ACTH or fragments thereof. Also disclosed are use of the composition and an article of manufacture including the therapeutic composition useful for carrying out the method.

Description

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The active ingredient of the therapeutic composition is ACTH including fragments thereof. The term "fragments" as used herein means ACTH from which amino acids in the sequence have been "cut off" to such an extent that the therapeutic effect of the fragments is at least equal to that of the ACTH. As a non-limiting example may be mentioned Synacthen (Ciba-Geigy, Basel, Switzerland) which is a synthetic N-terminal fragment (1-24) of ACTH. Several preparations comprising fragments of ACTH are commer- cially available. The selection thereof for the purpose of the invention is within the purview of one skilled in the art, i.e. a physician.

The amount of the therapeutically active ingredient that is administered and the dosage regimen for treating a disease condition with the composition depends on a variety of factors, including the age, weight, sex and medical condition of the patient, the severity of the disease, the route and frequency of administration, and the particular compound employed, and thus may vary widely. Thus, a skilled physician is able to determine the appropriate dosage considering the factors mentioned above. By way of example the following treatment scheme may be mentioned:

The preparation is Synacthen Depot, which is given by an intramuscular injection.

Month 1 : 1 mg once a week

Month 2: 0.75 mg twice a week

Month 3-6: 1 mg twice a week

Month 7 0.75 mg twice a week Month 8 1 mg once a week

Month 9 0.5 mg once a week According to a preferred embodiment of the invention an intramuscular injection of 1 mg ACTH, or fragments thereof, twice a week, is associated with significant long-term improvements of the blood fat contents in serum in patients who are on therapy on steroids and statins. According to still another preferred embodiment a preparation of ACTH or fragments thereof is injected sub- cutaneously. Injectable preparations can contain such carriers or diluents as water, saline, dextrose, etc, which are preferable isotonic and sterile.

According to a further preferred embodiment a preparation of ACTH or fragments thereof is administered through the nasal route.

The ACTH preparation is most preferably sold in a package containing a disposable syringe having said preparation present therein. Alternatively, the preparation is contained in an inhaling device such as a spray device .

Accordingly, at present the preferred route is the intramuscular, subcutaneous and the nasal route.

Other features and advantages of the invention will be apparent from the following description of preferred embodiments and from the claims. Example 1 Ten patients were studied. They were all hyper- lipidemic (LDL cholesterol>3.5 mmol/L) in spite of ongoing treatment with Simvastatin (Zocord) at the maximal recommended dose i.e., 40 mg daily, and dietary advice. In all cases, the hyperlipidemia was probably primary since there was no, evidence of secondary influence on the lipoprotein metabolism (such as renal or endocrinological disease) .

The patients received Synacthen Depot 1 mg/mL intramuscularly at 8 am on days 1-4. Blood samples were collected on days 1 (before the injection), 5 and 18. On day 5, the LDL cholesterol concentrations were significantly reduced by 20% as compared with day 1. On day 18, the LDL cholesterol concentrations were again similar to those on day 1. There were no changes in the serum concentrations of HDL cholesterol or triglycerides. Thus, in spite of ongoing high-dose treatment with Simvastatin, short-term treatment with ACTH at a pharma- P¹

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Claims

1. A method of treating a patient who is on therapy with corticosteroids and statins, said method comprising the steps of : identifying a patient who is on therapy with corticosteroids and statins; providing a therapeutic composition comprising adrenocorticotrophic hormone (ACTH) , or fragments thereof ; and administering to said patient a therapeutically effective amount of said composition.

2. A method as claimed in claim 1, wherein the com- position is administered intramuscularly.

3. Use of a composition comprising adrenocorticotrophic hormone (ACTH) , or fragments thereof for manufacturing a drug for the treatment of a patient who is on therapy with corticosteroids and statins, said composi- tion lowering the blood fat contents in serum.

4. An article of manufacture comprising packaging material and a therapeutic composition contained within said packaging material, wherein the therapeutic composition is therapeutically effective for lowering the blood fat contents in serum, and wherein the packaging material comprises a label that indicates that the therapeutic composition can be used for lowering the blood fat contents in serum in patients on therapy with corticosteroids and statins.