Pharmaceutical compositions for combination therapy

Abstract

This invention relates to the use of pharmaceutical compositions comprising a therapeutically effective combination of Tesofensine and Metoprolol for preventing the cardiovascular side effects of Tesofensine, while leaving the robust inhibitory efficacy on food intake and body weight loss unaffected.

1 . A method of treating type 2 diabetes in a human comprising:
 administering Tesofensine, or a pharmaceutically acceptable salt thereof, to the human;   in combination with Metoprolol, or a pharmaceutically acceptable salt thereof,   wherein the combination is effective in treating the type 2 diabetes and wherein the combination is effective in preventing or alleviating drug-induced cardiovascular side-effects.   
     
     
         2 . The method of  claim 1 , wherein 0.1 mg to 1 mg of Tesofensine is administered daily daily. 
     
     
         3 . The method of  claim 1 , wherein 0.1 mg to about 0.5 mg of Tesofensine is administered daily daily. 
     
     
         4 . The method of  claim 1 , wherein 0.25 mg to 200 mg of the Metoprolol is administered daily. 
     
     
         5 . The method of  claim 1 , wherein 25 mg to 100 mg of the Metoprolol is administered daily. 
     
     
         6 . The method of  claim 1 , wherein the human is a pre-obese human, an obese human, or a morbid obese human. 
     
     
         7 . The method of  claim 1 , wherein the drug-induced cardiovascular side effects are increased heart rate, increased diastolic blood pressure, or increased systolic blood pressure, or a combination thereof. 
     
     
         8 . A method of treating metabolic syndrome in a human comprising:
 administering Tesofensine, or a pharmaceutically acceptable salt thereof, to the human;   in combination with Metoprolol, or a pharmaceutically acceptable salt thereof,   wherein the combination is effective in treating the metabolic syndrome and wherein the combination is effective in preventing or alleviating drug-induced cardiovascular side-effects.   
     
     
         9 . The method of  claim 8 , wherein 0.1 mg to 1 mg of the Tesofensine is administered daily daily. 
     
     
         10 . The method of  claim 8 , wherein 0.1 mg to about 0.5 mg of the Tesofensine is administered daily daily. 
     
     
         11 . The method of  claim 8 , wherein 0.25 mg to 200 mg of the Metoprolol is administered daily. 
     
     
         12 . The method of  claim 8 , wherein 25 mg to 100 mg of the Metoprolol is administered daily. 
     
     
         13 . The method of  claim 8 , wherein the human is a pre-obese human, an obese human, or a morbid obese human. 
     
     
         14 . The method of  claim 8 , wherein the drug-induced cardiovascular side effects are increased heart rate, increased diastolic blood pressure, or increased systolic blood pressure, or a combination thereof.