Methods and compositions for treating diabetes, metabolic syndrome and other conditions
AssigneeCortendo AB (publ)
InventorPer Marin
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Abstract
Pharmaceuticals compositions comprising the 2S, 4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R, 4S ketoconazole enantiomer are useful to reduce cortisol synthese and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.
Claims33
A method for treating a disease or condition associated with elevated cortisol levels or activity in a patient in need of such treatment, wherein the disease or condition is not a fungal infection, said method comprising administering an immediate release pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of 2S,4R ketoconazole enantiomer substantially free of the 2R,4S ketoconazole enantiomer to said patient, and wherein the immediate release pharmaceutical composition is administered one to six times a day for multiple consecutive days for at least a week.
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A method of reducing cortisol levels in a patient diagnosed with a condition characterized by elevated cortisol levels, comprising providing a constant exposure to 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-[(1H-imidazol-1-yl)-methyl]-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine to the patient over a period of at least 14 days, optionally at least 28 days, wherein said constant daily exposure is provided by administering a constant daily dose of the 2S4R enantiomer, and wherein the constant daily dose of the 2R4S enantiomer is substantially free of the 2R,4S enantiomer.
A method for treating a disease or condition associated with elevated cortisol levels or activity in a patient in need of such treatment, said method comprising administering an immediate release pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of 2S,4R ketoconazole enantiomer substantially free of the 2R,4S ketoconazole enantiomer to said patient, wherein the therapeutically effective amount of the 2S,4R ketoconazole enantiomer is from about 50 mg to about 800 mg, and wherein the immediate release pharmaceutical composition is administered one to six times a day for multiple consecutive days for at least a week.
Dependencies are inferred from the claim text.