USE OF SOMATOSTATIN ANALOGS IN CONTROL OF HYPOGLYCEMIA

• US 20110124555A1
• Filed: 07/07/2009
• Published: 05/26/2011
• Est. Priority Date: 07/08/2008
• Status: Active Grant

• Current Assignee: Recordati AG (Fimei Finanziaria Industriale Mobiliare ED Immobiliare SPA)
• Original Assignee: Novartis Ag
• Inventors: Schmid, Herbert
• Granted Patent: US 9,314,508 B2
• Time in Patent Office: Days
• US Class Current: 514/6.8
• CPC Class Codes: A61K 38/12 Cyclic peptides , e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C A61K38/043 - A61K38/046 take precedence
• CPC Class Codes: A61K 38/31 Somatostatins
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates to the use of a Somatostatin (SRIF) analog which has a high binding affinity to human SSTR1,2,3,5, or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for the control of hypoglycemia.

Claims

1. A method of treating or controlling endogenous hyperinsulinemic hypoglycemia using pasireotide or a pharmaceutically acceptable salt thereof.

2. The method according to claim 1 wherein the endogenous hyperinsulinemic hypoglycemia is not caused by insulinoma.

3. The method according to claim 1 for the prevention of recurrent endogenous hyperinsulinemic hypoglycemia.

4. The method according to claim 1 for the treatment of nesidioblastosis, congenital hyperinsulinaemic hypoglycaemia, overdose of insulin secretagogue, paraneoplastic hyperinsulinism, noninsulinoma pancreatogenous hypoglycemia syndrome (NIPHS), post-prandial reactive hypoglycemia, hypoglycemia in the Beckwith-Wiedemann syndrome, islet hyperplasia causing hypoglycemia, hypoglycemia in patients with falciparum malaria, congenital hypeinsulinemic hypoglycemia including patients with mutations to the following genes:

ABCC8, KCNJ11, HADH, GGK, GLUD1, HNF4A and SLC16A1, or insulin autoimmune hypoglycemia (antibody to insulin or antibody to insulin receptor).

5. The method according to claim 4 wherein the insulin secretagogue is sulfonylureas, nateglinide or repaglinide.

6. The method according to claim 1 for the treatment of hypoglycemia caused by one or more drugs selected from the group consisting of i) alcohol, ii) Cibezoline, Gatifloxin, Pentamidine, Quinine, Indomethacin, Glucagon (during endoscopy), iii) Chloroquineoxaline sulfonamide, Artesunate/artemisin/artemether, IGF-1, Lit-ium, Propoxyphene/dextropropoxyphene, and iv) Angiotensin converting enzyme inhibitors, Angiotensin receptor antagonists, beta-Adrenergic receptor antagonists, Levofloxacin, Mifepristone, Disopyramide, Trimehtoprim-sulfamethoxazole, Heparin, 6-mercaptopurine.

7. The method according to claim 1 for the treatment of hypoglycemia caused by a critical illness such as hepatic, renal or cardiac failure, sepsis, inanition.

8. The method according to claim 1 for the treatment of hypoglycemia caused by hormone deficiency.

9. A method of treating or controlling endogenous hyperinsulinemic hypoglycemia in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of pasireotide a pharmaceutically acceptable salt thereof.

10. The method according to claim 9 wherein the method is for the treatment or control of insulin secretagogue induced-hypoglycemia.

11. The method according to claim 9 wherein the method is for preventing recurrent hypoglycemia.

12. The method according to claim 9 wherein the method is for the treatment of nesidioblastosis, congenital hyperinsulinaemic hypoglycaemia, overdose of insulin secretagogues, paraneoplastic hyperinsulinism, noninsulinoma pancreatogenous hypoglycemia syndrome (NIPHS), post-prandial reactive hypoglycemia, hypoglycemia in the Beckwith-Wiedemann syndrome, islet hyperplasia causing hypoglycemia, hypoglycemia in patients with falciparum malaria, congenital hypeinsulinemic hypoglycemia including patients with mutations to the following genes:

ABCC8, KCNJ11, HADH, GGK, GLUD1, HNF4A and SLC16A1, insulin autoimmune hypoglycemia (antibody to insulin or antibody to insulin receptor).

13. A pharmaceutical composition for treatment of endogenous hyperinsulinemic hypoglycemia, comprising pasireotide or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable diluents or carriers.

14. A commercial package comprising pasireotide or a pharmaceutically acceptable salt thereof, together with instructions for use thereof in the treatment of endogenous hyperinsulinemic hypoglycemia.