ORAL OCTREOTIDE ADMINISTERED IN COMBINATION WITH OTHER THERAPEUTIC AGENTS
This invention relates to combination therapy of a subject suffering from acromegaly. The method of treatment comprises administration to the subject of a therapeutically effective amount of oral somatostatin receptor ligand (SRL) e.g. octreotide in combination with a therapeutically effective amount of a dopamine agonist and/or a growth hormone receptor antagonist and/or a selective estrogen receptor modulator (SERM) and/or a 2 nd somatostatin receptor ligand (SRL).
1 . A method of treatment of a subject suffering from acromegaly which comprises administration to the subject of a therapeutically effective amount of an oral somatostatin receptor ligand (SRL) in combination with a therapeutically effective amount of a dopamine agonist or a growth hormone receptor antagonist or a 2nd somatostatin receptor ligand (SRL) or a selective estrogen receptor modulator (SERM).
2 . The method of treatment of claim 1 wherein the oral somatostatin receptor ligand (SRL) is octreotide or lanreotide or pasireotide.
3 - 5 . (canceled)
6 . The method of claim 1 wherein the dopamine agonist is cabergoline.
7 . The method of- claim 1 wherein the dopamine agonist is bromocriptine.
8 . The method of- claim 1 wherein the growth hormone receptor antagonist is pegvisomant or ATL1103.
9 - 12 . (canceled)
13 . The method of claim 6 wherein the administration of cabergoline comprises about 0.2 to about 5 mg of cabergoline weekly.
14 - 16 . (canceled)
17 . The method of claim 13 wherein the administration of cabergoline is gradually increased from 0.5 mg×2 per week for first two weeks, 1 mg×2 per week for additional two weeks, followed by 1.5 mg×2 per week for additional two weeks reaching a maintenance dose of 1.75 mg×2 per week
18 . The method of claim 13 wherein the administration of cabergoline is a maintenance dose of 3.0 mg to 3.5 mg weekly.
19 . The method of claim 8 wherein the administration of pegvisomant comprises about 2 mg to about 60 mg of pegvisomant daily or once, twice, three, four, five or six times per week.
20 - 21 . (canceled)
22 . The method of claim 1 wherein the SERM is clomiphene.
23 - 27 . (canceled)
28 . The method of claim 1 wherein the 2nd somatostatin receptor ligand is a long-acting injectable formulation.
29 - 32 . (canceled)
33 . The method of claim 2 wherein the administration of oral octreotide comprises about 10 to about 80 mg of octreotide daily, such as 10, 20, 30, 40, 50, 60, 70 or 80 mg daily.
34 - 38 . (canceled)
39 . A unit dosage formulation for oral administration comprising an oral SRL and a dopamine agonist.
40 . The unit dosage formulation of claim 39 wherein the dopamine agonist is cabergoline.
41 . The unit dosage formulation of claim 39 wherein the oral SRL is octreotide.
42 . (canceled)
43 . A unit dosage formulation for oral administration comprising an oral SRL and SERM.
44 . The unit dosage formulation of claim 43 wherein the SERM is clomiphene.
45 . The unit dosage formulation of claim 43 wherein the oral SRL is octreotide.
46 . The unit dosage formulation of claim 45 which comprises 5-120 mg octreotide and clomiphene.
47 - 67 . (canceled)