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 hyper lipidemic 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 comprising dosing the hyperlipidemic with an effective antihyperlipidemic amount of nicotinic acid or a compound metabolized to nicotinic acid by the body, once per day in the evening or at night combined with a pharmaceutically acceptable carrier, to produce a reduction in total and LDL cholesterol, triglycerides and Lp(a), with a significant increase in HDL cholesterol compared to the baseline HDL level prior to treatment with the antihyperlipidemic, wherein said compound metabolized to nicotinic acid by the body is selected from the group consisting of nicotinyl alcohol tartrate, d-glucitol hexanicotinate, aluminum nicotinate, niceritrol, and d,1-alpha-tocopheryl nicotinate. 
     
     
         14 . The method according to  claim 13 , wherein the hyperlipidemic is dosed with from about 250 milligrams to about 3000 milligrams by weight of nicotinic acid. 
     
     
         15 . The method according to  claim 13 , wherein said method causes little or no elevation in liver function markers, uric acid increases, or elevations in fasting glucose levels. 
     
     
         16 . The method according to  claim 13 , wherein the release rate of said nicotinic acid or compound metabolized by the body to nicotinic acid is from about 2.0% per hour to about 25% per hour. 
     
     
         17 . The method according to  claim 13 , wherein said nicotinic acid or compound metabolized to nicotinic acid by the body is prepared by formulating said nicotinic acid or compound metabolized to nicotinic acid into a sustained release formulation or tablet with from about 5 to about 50 parts by weight of hydroxypropyl methylcellulose per 100 parts by weight of said formulation or tablet. 
     
     
         18 . The method according to  claim 13 , wherein said nicotinic acid or compound metabolized to nicotinic acid by the body is dosed in the form of a sustained release formulation or tablet containing from about 1 to about 4 parts by weight of binder per 100 parts by weight of said formulation or tablet. 
     
     
         19 . The method according to  claim 18 , wherein said binder is a polymer having the repeating polymerization unit 1-ethenyl-2-pyrrolidone. 
     
     
         20 . The method according to  claim 13 , wherein said nicotinic acid or compound metabolized to nicotinic acid by the body is dosed in the form of a sustained release formulation or tablet comprising from about 0.5 to about 2.5 parts by weight of a lubricating agent per 100 parts by weight of said formulation or tablet. 
     
     
         21 . The method according to  claim 20 , wherein said lubricating agent is selected from the group consisting of stearic acid and magnesium stearate. 
     
     
         22 . The method according to  claim 13 , wherein the compound metabolized to nicotinic acid by the body is nicotinyl alcohol tartrate. 
     
     
         23 . The method according to  claim 22 , wherein the amount of nicotinyl alcohol tartrate is from about 100 milligrams to about 500 milligrams per dosage unit.