Combination therapy for treating hypercholesterolemia

Abstract

The invention relates to methods for treating hypercholesterolemia and atherosclerosis, and reducing serum cholesterol in a mammal. The methods of the invention comprise administering to a mammal a first amount of a bile acid sequestrant compound which is an unsubstituted polydiallylamine polymer and a second amount of a cholesterol-lowering agent. The first and second amounts together comprise a therapeutically effective amount. The invention further relates to pharmaceutical compositions useful for the treatment of hypercholesterolemia and atherosclerosis, and for reducing serum cholesterol. The pharmaceutical compositions comprise a combination of a first amount of an unsubstituted polydiallylamine polymer compound and a second amount of a cholesterol-lowering agent. The first and second amounts comprise a therapeutically effective amount. The pharmaceutical compositions of the present invention may optionally contain a pharmaceutically acceptable carrier.

1 . A pharmaceutical composition comprising a unit dosage form a polydiallylamine homopolymer, said homopolymer characterized in that the polymer is substantially free of alkylated amine monomers and a pharmaceutically acceptable carrier. 
     
     
         2 . The pharmaceutical composition of  claim 1  wherein said homopolymer is crosslinked by means of a multifunctional crosslinking agent, and said crosslinking agent is present in an amount from about 2.5-20% by weight, based upon the combined weight of monomer and crosslinking agent. 
     
     
         3 . The pharmaceutical composition of  claim 2  wherein the polymer is crosslinked using epichlorohydrin. 
     
     
         4 . The pharmaceutical composition of  claim 1  wherein the polydiallylamine homopolymer is characterized by one or more monomeric units of the formulae: 
       
         
           
           
               
               
           
         
       
       r a combination thereof and salts thereof. 
     
     
         5 . The pharmaceutical composition of  claim 4  wherein the monomeric units are in the free-base form. 
     
     
         6 . The pharmaceutical composition of  claim 4  wherein the monomeric units are a salt or a partial salt. 
     
     
         7 . A pharmaceutical composition of  claim 1  wherein the unit dosage form is a tablet. 
     
     
         8 . A pharmaceutical composition of  claim 1  wherein the unit dosage form is a capsule. 
     
     
         9 . A pharmaceutical composition of  claim 1  wherein the polydiallylamine homopolymer is water-insoluble.