Methods for treating visceral fat conditions

Abstract

Disclosed are methods and compositions for treating visceral fat conditions and/or metabolic syndrome using combinations of naltrexone and bupropion.

What is claimed is: 
     
         1 . Use of a first compound and a second compound in the preparation of a medicament for the treatment of a visceral fat condition in a person who has been identified or diagnosed as being in need of said treatment, wherein said first compound is naltrexone or a pharmaceutically acceptable salt thereof, and said second compound is bupropion or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The use according to  claim 1 , wherein said first compound is in an amount effective to enhance the treatment effect of said second compound compared to the administration of said second compound alone. 
     
     
         3 . The use according to  claim 1 , wherein said second compound is in an amount effective to enhance the treatment effect of said first compound compared to the administration of said first compound alone. 
     
     
         4 . The use according to any of  claims 1  to  3 , wherein said person has an amount of visceral fat that increases the risk and/or severity of at least one disease or condition selected from coronary heart disease, cancer, diabetes, glucose intolerance, hyperinsulinemia, hypertension, periodontal disease, and a metabolic syndrome. 
     
     
         5 . The use according to any of  claims 1  to  3 , wherein said person has been identified or diagnosed using a method comprising the determination of a waist-to-hip measurement ratio. 
     
     
         6 . The use according to  claim 5 , wherein said person has a waist-to-hip measurement ratio of about 0.8 or greater. 
     
     
         7 . The use according to any of  claims 1  to  6 , wherein said person has been identified or diagnosed using a method comprising analyzing one or more test selected from a computed tomography (CT) scan, a magnetic resonance imaging scan, and an ultrasonogram. 
     
     
         8 . The use according to  claim 7 , wherein the intra-abdominal fat area of said person, as determined by CT scanning in a single tomographic slice at the L 4 -L 5  level, is about 80 cm 2  or greater. 
     
     
         9 . The use according to any of  claims 1  to  8 , wherein said person has metabolic syndrome. 
     
     
         10 . The use according to  claim 9 , wherein said person has been identified or diagnosed using a method comprising identifying at least three patient characteristics selected from abdominal obesity, elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol levels, high blood pressure, and impaired fasting blood glucose. 
     
     
         11 . The use according to  claim 10 , wherein one of said patient characteristics is abdominal obesity. 
     
     
         12 . The use according to any of  claims 1  to  11 , wherein said treatment of a visceral fat condition comprises at least one effect selected from a reduction of abdominal obesity, a reduction of triglyceride levels, an increase of high-density cholesterol levels, a reduction in blood pressure, and an improvement in fasting blood glucose levels. 
     
     
         13 . The use according to any of  claims 1  to  12 , wherein said treatment of a visceral fat condition comprises a reduction of said person's susceptibility to a heart disease. 
     
     
         14 . The use according to  claim 13 , wherein said reduction of said person's susceptibility to a heart disease comprises a reduction of inflammation. 
     
     
         15 . The use according to  claim 14 , wherein said reduction of inflammation comprises a reduction of the serum level of interleukin 6. 
     
     
         16 . The use according to  claim 14 , wherein said reduction of inflammation comprises a reduction of the serum level of C-reactive protein. 
     
     
         17 . The use according to any of  claims 1  to  16 , wherein said person is viscerally obese. 
     
     
         18 . The use according to any of  claims 1  to  17 , wherein the body mass index of said person is greater than about 30. 
     
     
         19 . The use according to any of  claims 1  to  17 , wherein the body mass index of said person is greater than about 40. 
     
     
         20 . The use according to any of  claims 1  to  17 , wherein the body mass index of said person is less than about 30. 
     
     
         21 . The use according to any of  claims 1  to  20 , wherein said first compound and said second compound are administered together in a single dosage form. 
     
     
         22 . The use according to any of  claims 1  to  20 , wherein said first compound and said second compound are administered in separate dosage forms. 
     
     
         23 . The use according to  claim 22 , wherein said first compound is administered prior to, concurrently with, or subsequent to said second compound. 
     
     
         24 . The use according to any of  claims 1  to  23 , wherein the amount of said bupropion or pharmaceutically acceptable salt thereof is in the range of from about 100 mg to about 600 mg. 
     
     
         25 . The use according to any of  claims 1  to  24 , wherein the amount of said naltrexone or pharmaceutically acceptable salt thereof is in the range of from about 4 mg to about 50 mg. 
     
     
         26 . The use according to any of  claims 1  to  25 , wherein said naltrexone or pharmaceutically acceptable salt thereof is a sustained-release naltrexone or pharmaceutically acceptable salt thereof. 
     
     
         27 . The use according to any of  claims 1  to  26 , wherein said bupropion or pharmaceutically acceptable salt thereof is a sustained-release bupropion or pharmaceutically acceptable salt thereof. 
     
     
         28 . A method of treating a visceral fat condition, comprising administering a first and a second compound to a person who has been identified or diagnosed as being in need of treatment for a visceral fat condition in order to treat said visceral fat condition, wherein said first compound is naltrexone or a pharmaceutically acceptable salt thereof, and said second compound is bupropion or a pharmaceutically acceptable salt thereof. 
     
     
         29 . The method of  claim 28 , wherein said first compound is in an amount effective to enhance the treatment effect of said second compound compared to the administration of said second compound alone. 
     
     
         30 . The method of  claim 28 , wherein said second compound is in an amount effective to enhance the treatment effect of said first compound compared to the administration of said first compound alone. 
     
     
         31 . The method of any of  claims 28  to  30 , wherein said person has an amount of visceral fat that increases the risk and/or severity of at least one disease or condition selected from coronary heart disease, cancer, diabetes, glucose intolerance, hyperinsulinemia, hypertension, periodontal disease, and a metabolic syndrome. 
     
     
         32 . The method of any of  claims 28  to  31 , wherein said person has been identified or diagnosed using a method comprising the determination of a waist-to-hip measurement ratio. 
     
     
         33 . The method of  claim 32 , wherein said person has a waist-to-hip measurement ratio of about 0.8 or greater. 
     
     
         34 . The method of any of  claims 28  to  33 , wherein said person has been identified or diagnosed using a method comprising analyzing one or more test selected from a computed tomography (CT) scan, a magnetic resonance imaging scan, and an ultrasonogram. 
     
     
         35 . The method of  claim 34 , wherein the intra-abdominal fat area of said person, as determined by CT scanning in a single tomographic slice at the L 4 -L 5  level, is about 80 cm 2  or greater. 
     
     
         36 . The method of any of  claims 28  to  35 , wherein said person has metabolic syndrome. 
     
     
         37 . The method of  claim 36 , wherein said person has been identified or diagnosed using a method comprising identifying at least three patient characteristics selected from abdominal obesity, elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol levels, high blood pressure, and impaired fasting blood glucose. 
     
     
         38 . The method of  claim 37 , wherein one of said patient characteristics is abdominal obesity. 
     
     
         39 . The method of any of  claims 28  to  38 , wherein said treatment of a visceral fat condition comprises at least one effect selected from a reduction of abdominal obesity, a reduction of triglyceride levels, an increase of high-density cholesterol levels, a reduction in blood pressure, and an improvement in fasting blood glucose levels. 
     
     
         40 . The method of any of  claims 28  to  39 , wherein said treatment of a visceral fat condition comprises a reduction of said person's susceptibility to a heart disease. 
     
     
         41 . The method of  claim 40 , wherein said wherein said reduction of said person's susceptibility to a heart disease comprises a reduction of inflammation. 
     
     
         42 . The method of  claim 41 , wherein said reduction of inflammation comprises a reduction of the serum level of interleukin 6. 
     
     
         43 . The method of  claim 41 , wherein said reduction of inflammation comprises a reduction of the serum level of C-reactive protein. 
     
     
         44 . The method of any of  claims 28  to  43 , wherein said person is viscerally obese. 
     
     
         45 . The method of any of  claims 28  to  44 , wherein the body mass index of said person is greater than about 30. 
     
     
         46 . The method of any of  claims 28  to  44 , wherein the body mass index of said person is greater than about 40. 
     
     
         47 . The method of any of  claims 28  to  44 , wherein the body mass index of said person is less than about 30. 
     
     
         48 . The method of any of  claims 28  to  47 , wherein said first compound and said second compound are administered together in a single dosage form. 
     
     
         49 . The method of any of  claims 28  to  47 , wherein said first compound and said second compound are administered in separate dosage forms. 
     
     
         50 . The method of  claim 49 , wherein said first compound is administered prior to, concurrently with, or subsequent to said second compound. 
     
     
         51 . The method of any of  claims 28  to  50 , wherein the amount of said bupropion or pharmaceutically acceptable salt thereof is in the range of from about 100 mg to about 600 mg. 
     
     
         52 . The method of any of  claims 28  to  51 , wherein the amount of said naltrexone or pharmaceutically acceptable salt thereof is in the range of from about 4 mg to about 50 mg. 
     
     
         53 . The method of any of  claims 28  to  52 , wherein said naltrexone or pharmaceutically acceptable salt thereof is a sustained-release naltrexone or pharmaceutically acceptable salt thereof. 
     
     
         54 . The method of any of  claims 28  to  53 , wherein said bupropion or pharmaceutically acceptable salt thereof is a sustained-release bupropion or pharmaceutically acceptable salt thereof. 
     
     
         55 . A pharmaceutical composition for the treatment of a visceral fat condition in a person who has been identified or diagnosed as being in need of said treatment, said pharmaceutical composition comprising a first compound, wherein said first compound is naltrexone or a pharmaceutically acceptable salts thereof, and a second compound, wherein said second compound is bupropion or a pharmaceutically acceptable salt thereof. 
     
     
         56 . The pharmaceutical composition of  claim 55 , wherein said first compound and said second compound are in a single dosage form. 
     
     
         57 . The pharmaceutical composition of  claim 55  or  56 , wherein said first compound and said second compound in separate dosage forms. 
     
     
         58 . The pharmaceutical composition of  claim 57 , wherein said first compound is administered prior to, concurrently with, or subsequent to said second compound. 
     
     
         59 . The pharmaceutical composition of any of  claims 55  to  58 , wherein said composition comprises from about 100 mg to about 600 mg of said bupropion or pharmaceutically acceptable salt thereof. 
     
     
         60 . The pharmaceutical composition of any of  claims 55  to  59 , wherein the amount of said naltrexone or pharmaceutically acceptable salt thereof is in the range of from about 4 mg to about 50 mg. 
     
     
         61 . The pharmaceutical composition of any of  claims 55  to  60 , wherein said naltrexone or pharmaceutically acceptable salt thereof is a sustained-release naltrexone or pharmaceutically acceptable salt thereof. 
     
     
         62 . The pharmaceutical composition of any of  claims 55  to  61 , wherein said bupropion or pharmaceutically acceptable salt thereof is a sustained-release bupropion or pharmaceutically acceptable salt thereof.