Nicotinic acid compositions for treating hyperlipidemia and related methods therefor

Abstract

An orally administered antihyperlipidemia composition according to the present invention includes from about 250 to about 3000 parts by weight of nicotinic acid, and from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose. Also, a method of treating hyperlipidemia in a hyperlipidemic having a substantially periodic physiological loss of consciousness, includes the steps of forming a composition having an effective antihyperlipidemic amount of nicotinic acid and a time release sustaining amount of a swelling agent. The method also includes the step of orally administering the composition to the hyperlipidemic once per day “nocturnally,” that is in the evening or at night.

1 - 12 . (canceled) 
     
     
         13 . A method for treating hyperlipidemia in a hyperlipidemic, the method comprising the steps of:
 dosing the hyperlipidemic once a day, in the evening or at night, with a dose of about 1500 to about 3000 mg of nicotinic acid, wherein the antihyperlipidemic's total cholesterol, LDL cholesterol, triglycerides and Lp(a) are reduced and the antihyperlipidemic's HDL cholesterol is increased.   
     
     
         14 . A method for treating hyperlipidemia in a hyperlipidemic, the method comprising the step of:
 dosing the hyperlipidemic once a day, in the evening or at night, with a dose of about 1500 mg to about 3000 mg of nicotinic acid, wherein said nicotinic acid is combined with at least one pharmaceutically acceptable carrier to form one or more sustained release oral solid dosage forms and further wherein the antihyperlipidemic's total cholesterol, LDL cholersterol, triglycerides and Lp(a) are reduced and the antihyperlipidemic's HDL cholesterol is increased.   
     
     
         15 . The method according to  claim 14 , wherein the increase in HDL cholesterol is at least 20% from baseline after at least eight weeks of said administration. 
     
     
         16 . The method according to  claim 14 , wherein the increase in HDL cholesterol is at least 25% from baseline after at least eight weeks of said administration. 
     
     
         17 . The method according to  claim 14 , wherein the reduction in LDL cholesterol is at least 10% from baseline after at least eight weeks of said administration. 
     
     
         18 . The method according to  claim 14 , wherein the increase in reduction in LDL cholesterol is at least 12% from baseline after at least eight weeks of said administration. 
     
     
         19 . The method according to  claim 14 , wherein the increase in reduction in LDL cholesterol is at least 13% from baseline after at least eight weeks of said administration. 
     
     
         20 . A method for treating hyperlipidemia in a hyperlipidemic, the method comprising the step of:
 dosing the hyperlipidemic once a day, in the evening or at night, with a dose of about 1500 mg to about 3000 mg of nicotinic acid, wherein said nicotinic acid is combined with at least one pharmaceutically acceptable carrier to form one or more sustained release oral solid dosage forms and further wherein the antihyperlipidemic's HDL cholesterol is significantly increased.   
     
     
         21 . A method for treating hyperlipidemia in a hyperlipidemic, the method comprising the step of:
 dosing the hyperlipidemic once a day, in the evening or at night, with a dose of about 1500 mg of nicotinic acid, wherein said nicotinic acid is combined with at least one pharmaceutically acceptable carrier to form one or more sustained release oral solid dosage forms and further wherein the antihyperlipidemic's HDL cholesterol is significantly increased.   
     
     
         22 . A method for treating hyperlipidemia in a hyperlipidemic, the method comprising the step of:
 dosing the hyperlipidemic once a day, in the evening or at night, with a dose of about 1500 mg of nicotinic acid, wherein said nicotinic acid is combined with at least one pharmaceutically acceptable carrier to form one or more sustained release oral solid dosage forms and further wherein the antihyperlipidemic's total cholesterol, LDL cholesterol, triglycerides and Lp(a) are reduced and the antihyperlipidemic's HDL cholesterol is significantly increased and further wherein there is minimum liver damage or elevations or increases in fasting glucose levels in the hyperlipidemic as a result of said treatment.   
     
     
         23 . A method for treating hyperlipidemia in a hyperlipidemic, the method comprising the step of:
 dosing the hyperlipidemic once a day, in the evening or at night, with a dose of about 1500 mg of nicotinic acid, wherein said nicotinic acid is combined with at least one pharmaceutically acceptable carrier to form one or more sustained release oral solid dosage forms and further wherein the antihyperlipidemic's total cholesterol, LDL cholesterol, triglycerides and Lp(a) are reduced and the antihyperlipidemic's HDL cholesterol is significantly increased and further wherein there is minimum liver damage or elevations or increases in fasting glucose levels in the hyperlipidemic as a result of said treatment.   
     
     
         24 . The method according to  claim 23  wherein the increase in HDL cholesterol is at least 20% from baseline after at least eight weeks of said administration. 
     
     
         25 . The method according to  claim 23  wherein the increase in HDL cholesterol is at least 25% from baseline after at least eight weeks of said administration. 155. 
     
     
         26 . The method according to  claim 23  wherein the reduction in LDL cholesterol is at least 10% from baseline after at least eight weeks of said administration. 
     
     
         27 . The method according to  claim 23  wherein the reduction in LDL cholesterol is at least 12% from baseline after at least eight weeks of said administration. 
     
     
         28 . The method according to  claim 23  wherein the reduction in LDL cholesterol is at least 13% from baseline after at least eight weeks of said administration.