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.

What is claimed is: 
     
         1 . A method of inducing hypophagia in a human comprising:
 administering 0.1 mg to 1 mg of Tesofensine, or a pharmaceutically acceptable salt thereof, to the human, daily;   in combination with 25 mg to 200 mg of Metoprolol, or a pharmaceutically acceptable salt thereof, daily,   wherein the combination is effective in inducing hypophagia and wherein the combination is effective in preventing or alleviating drug-induced cardiovascular side-effects.   
     
     
         2 . The method of  claim 1 , wherein the Tesofensine, or pharmaceutically acceptable salt thereof, is administered at a dosage of 0.1 mg to about 0.5 mg daily, based on the amount of free base. 
     
     
         3 . The method of  claim 1 , wherein the Metoprolol, or pharmaceutically acceptable salt thereof, is administered at a dosage of 25 mg to 100 mg daily, based on the amount of free base. 
     
     
         4 . The method of  claim 1 , wherein the human is a pre-obese human, an obese human, or a morbidly obese human. 
     
     
         5 . The method of  claim 1 , wherein the human suffers from over-eating disorders, bulimia nervosa, binge eating disorder, compulsive over-eating, impaired appetite regulation, metabolic syndrome, type 2 diabetes, dyslipidemia, atherosclerosis, or drug-induced obesity. 
     
     
         6 . The method of  claim 1 , wherein the human suffers from an over-eating disorder, bulimia nervosa, binge eating disorder, or compulsive over-eating. 
     
     
         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 . The method of  claim 1 , wherein the Tesofensine or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are administered separately. 
     
     
         9 . The method of  claim 1 , wherein the Tesofensine or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are administered in a combined form. 
     
     
         10 . The method of  claim 1 , wherein the Tesofensin or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are administered orally. 
     
     
         11 . The method of  claim 10 , wherein the Tesofensin or the pharmaceutically acceptable salt thereof and the Metoprolol or the pharmaceutically acceptable salt thereof are each administered as a tablet or capsule. 
     
     
         12 . The method of  claim 1 , wherein the human is administered a pharmaceutically acceptable salt of Tesofensine and the pharmaceutically acceptable salt of Tesofensine is Tesofensine citrate. 
     
     
         13 . The method of  claim 1 , wherein the human is administered a pharmaceutically acceptable salt of Metoprolol and the pharmaceutically acceptable salt of Metoprolol is metoprolol succinate.