Treatment of statin side effects using uridine derivatives

Abstract

The invention relates generally to treatment of muscle pain and/or fatigue and to methods of treatment of side effects of statin therapy which involve the administration of uridine, biological precursors or derivatives or uridine or salts, esters, tautomers or analogues thereof, which are collectively referred to as uridine related compounds. The invention is also directed to compositions, uses and combination packs or kits related to the treatment method.

1 . A method of treatment of one or more side effects of statin therapy comprising administering to a subject in need of such treatment an effective amount of uridine, a biological precursor or derivative of uridine or a salt, ester, tautomer or analogue thereof.  
     
     
         2 . The method according to  claim 1  wherein said side effect is one or more of rhabdomyolysis, headache, joint pain, fever, muscle pain, back pain, abdominal cramping, sleep disorder, rhinitis, sinusitis, dizziness, abnormal liver function and fatigue.  
     
     
         3 . The method according to  claim 1  wherein said side effect is muscle pain.  
     
     
         4 . The method according to  claim 1  wherein said side effect is fatigue.  
     
     
         5 . The method according to  claim 1  wherein the uridine precursor is orotic acid or a salt, ester, tautomer or analogue thereof.  
     
     
         6 . The method according to  claim 1  wherein the salt of a uridine precursor is magnesium orotate.  
     
     
         7 . A method of treatment of one or more side effects of statin therapy comprising administering to a subject in need of such treatment an effective amount of magnesium orotate, optionally in association with one of more pharmaceutically acceptable additives.  
     
     
         8 . The method according to  claim 7  wherein said side effect is one or more of rhabdomyolysis, headache, joint pain, fever, muscle pain, back pain, abdominal cramping, sleep disorder, rhinitis, sinusitis, dizziness, abnormal liver function and fatigue.  
     
     
         9 . The method according to  claim 7  wherein said side effect is muscle pain.  
     
     
         10 . The method according to  claim 7  wherein said side effect is fatigue.  
     
     
         11 . Use of uridine, a biological precursor or derivative of uridine or a salt, ester, tautomer or analogue thereof in preparation of a medicament for treatment of one or more side effects of statin therapy.  
     
     
         12 . The use according to  claim 11  wherein said side effect is one or more of rhabdomyolysis, headache, joint pain, fever, muscle pain, back pain, abdominal cramping, sleep disorder, rhinitis, sinusitis, dizziness, abnormal liver function and fatigue.  
     
     
         13 . The use according to  claim 11  wherein said side effect is muscle pain.  
     
     
         14 . The method according to  claim 11  wherein said side effect is fatigue.  
     
     
         15 . The use according to  claim 11  wherein the uridine precursor is orotic acid or a salt, ester, tautomer or analogue thereof.  
     
     
         16 . The use according to  claim 11  wherein the salt of a uridine precursor is magnesium orotate.  
     
     
         17 . Use of magnesium orotate and optionally one or more pharmaceutically acceptable additives in preparation of a medicament for treatment of one or more side effects of statin therapy.  
     
     
         18 . The use according to  claim 17  wherein said side effect is one or more of rhabdomyolysis, headache, joint pain, fever, muscle pain, back pain, abdominal cramping, sleep disorder, rhinitis, sinusitis, dizziness, abnormal liver function and fatigue.  
     
     
         19 . The use according to  claim 18  wherein said side effect is muscle pain.  
     
     
         20 . The method according to  claim 18  wherein said side effect is fatigue.  
     
     
         21 . A composition for treatment of one or more side effects of statin therapy comprising uridine, a biological precursor or derivative of uridine or a salt, ester, tautomer or analogue thereof in association with one or more pharmaceutically acceptable additives.  
     
     
         22 . The composition according to  claim 21  further comprising at least one statin.  
     
     
         23 . The composition according to  claim 22  wherein the at least one statin is selected from atorvastatin, simvastatin, pravastatin, lovastatin, cerivastatin, crestor and fluvastatin.  
     
     
         24 . The composition according to  claim 21  wherein the uridine precursor is orotic acid or a salt, ester, tautomer or analogue thereof.  
     
     
         25 . The composition according to  claim 21  wherein the salt of a uridine precursor is magnesium orotate.  
     
     
         26 . A composition for treatment of one or more side effects of statin therapy comprising magnesium orotate and one or more pharmaceutically acceptable additives.  
     
     
         27 . The composition according to  claim 26  further comprising at least one statin.  
     
     
         28 . The composition according to  claim 27  wherein the at least one statin is selected from atorvastatin, simvastatin, pravastatin, lovastatin, cerivastatin, crestor and fluvastatin.  
     
     
         29 . A composition comprising uridine, a biological precursor or derivative of uridine or a salt, ester, tautomer or analogue thereof and at least one statin.  
     
     
         30 . The composition according to  claim 29  wherein the at least one statin is selected from atorvastatin, simvastatin, pravastatin, lovastatin, cerivastatin, crestor and fluvastatin.  
     
     
         31 . The composition according to  claim 29  wherein the uridine precursor is orotic acid or a salt, ester, tautomer or analogue thereof.  
     
     
         32 . The composition according to  claim 29  wherein the salt of a uridine precursor is magnesium orotate.  
     
     
         33 . A combination pack or kit comprising at least one statin and uridine, a biological precursor or derivative of uridine or a salt, ester, tautomer or analogue thereof wherein said pack or kit is adapted for the simultaneous, sequential or separate administration of the statin and uridine, its biological precursor or derivative or a salt, ester, tautomer or analogue thereof.  
     
     
         34 . The combination pack or kit according to  claim 33  wherein the uridine precursor is orotic acid or a salt, ester, tautomer or analogue thereof.  
     
     
         35 . The combination pack or kit according to  claim 33  wherein the salt of a uridine precursor is magnesium orotate.  
     
     
         36 . A combination pack or kit comprising at least one statin and magnesium orotate wherein said pack or kit is adapted for the simultaneous, sequential or separate administration of the statin and magnesium orotate.  
     
     
         37 . The combination pack or kit according to  claim 36  wherein the at least one statin is selected from atorvastatin, simvastatin, pravastatin, lovastatin, cerivastatin, crestor and fluvastatin.