Medicament for preventing and/or treating peripheral neuropathies

Abstract

This invention disclosed the use of acetyl L-carnitine or of a pharmaceutically acceptable salt thereof for the preparation of a medicament for preventing and/or treating peripheral neuropathies induced by the administration of a peripheral neuropathy—inducing anticancer agent. In particular said anticancer agent is selected from the group consisting of the family of platin compounds, taxanes, epothilone class and vinca alkaloids, farnesyl transferase inhibitors, thalidomide, 5-fluorouracil, cryptophycin analogues, proteasome inhibitors. Said medicament can be administered in a co-ordinated manner to a subject suffering from said peripheral neuropathies, or expected to suffer from said peripheral neuropathies. Beneficial effects on the patient's quality of life are achieved and an improvement of therapeutic index of the anticancer agent is obtained.

1 . The use of acetyl L-carnitine or of a pharmaceutically acceptable salt thereof for the preparation of a medicament for preventing and/or treating peripheral neuropathies induced by the administration of a peripheral neuropathy-inducing anticancer agent, with the proviso that said anticancer agent is not taxol or cisplatin.  
   
   
       2 . The use according to  claim 1 , wherein said medicament is suitable for the administration in a co-ordinated manner.  
   
   
       3 . The use according to  claim 1 , wherein said peripheral neuropathy-inducing anticancer agent is selected from the group of the family of platin compounds, taxanes, epothilone class and vinca alkaloids, farnesyl transferase inhibitors, thalidomide, 5-fluorouracil, cryptophycin analogues, proteasome inhibitors.  
   
   
       4 . The use according to  claim 3 , wherein said anticancer agent is selected from the group consisting of Carboplatin, Oxaliplatin, Docetaxel, Epothilone, Vinorelbine, Vincristine, the farnesyl transferase inhibitor R11577, thalidomide, the cryptophycin analogue LY355703, the proteasome inhibitor PS341.  
   
   
       5 . The use according to  claim 2 , wherein said administration is substantially simultaneous.  
   
   
       6 . The use according to  claim 2 , wherein said administration is sequential.  
   
   
       7 . The use according to  claim 2 , wherein said administration is in the form of a composition comprising said acetyl L-carnitine or a pharmaceutically acceptable salt thereof in combination and in a mixture with said anticancer agent in addition to optional pharmaceutically acceptable excipients and/or vehicles.  
   
   
       8 . The use according to  claim 1 , wherein 0.1 to 3 g/day of acetyl L-carnitine or of an equivalent amount of a pharmaceutically acceptable salt thereof are administered.  
   
   
       9 . The use according to  claim 1 , wherein said pharmacologically acceptable salt of acetyl L-carnitine is selected from the group consisting of chloride, bromide, orotate, acid aspartate, acid citrate, acid phosphate, fumarate and acid fumarate, maleate and acid maleate, acid oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate.  
   
   
       10 . The use according to  claim 1 , wherein said medicament is to be administered to a subject in view of the need of a treatment with said anticancer agent.  
   
   
       11 . The use according to  claim 10 , wherein said medicament is to be administered immediately before or immediately after surgical removal of the tumor.  
   
   
       12 . The use according to  claim 10 , wherein said anticancer agent is alternative to surgical removal of the tumor.  
   
   
       13 . The use according to  claim 1 , wherein a further carnitine or a pharmaceutically acceptable salt thereof is added.  
   
   
       14 . The use according to  claim 1 , wherein a further anticancer agent is added.  
   
   
       15 . A composition which in combination comprises: 
 a) acetyl L-carnitine or a pharmaceutically acceptable salt thereof;    b) a peripheral neuropathy-inducing anticancer agent.    
   
   
       16 . The composition according to  claim 15 , wherein said anticancer agent is selected from the group of the family of platin compounds, taxanes, epothilone class, vinca alkaloids.  
   
   
       17 . The composition according to  claim 16 , wherein said anticancer agent is selected from the group consisting of platin compounds, taxanes, epothilone class and vinca alkaloids, farnesyl transferase inhibitors, thalidomide, 5-fluorouracil, cryptophycin analogues, proteasome inhibitors.  
   
   
       18 . The composition according to  claim 17 , wherein said anticancer agent is selected from the group consisting of Carboplatin, Oxaliplatin, Docetaxel, Epothilone, Vinorelbine, Vincristine, the farnesyl transferase inhibitor R11577, thalidomide, the cryptophycin analogue LY355703, the proteasome inhibitor PS341.  
   
   
       19 . The composition according to  claim 15 , wherein said pharmacologically acceptable salt of acetyl L-carnitine is selected from the group consisting of chloride, bromide, orotate, acid aspartate, acid citrate, acid phosphate, fumarate and acid fumarate, maleate and acid maleate, acid oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate.  
   
   
       20 . The composition according to  claim 15 , wherein a further carnitine or a pharmaceutically acceptable salt thereof is added.  
   
   
       21 . The composition according to  claim 15 , wherein a further anticancer agent is added.  
   
   
       22 . A kit comprising 
 a) a pharmaceutical composition comprising a therapeutically effective amount of a peripheral neuropathy-inducing anticancer agent.    b) a pharmaceutical composition comprising acetyl L-carnitine or a pharmaceutically acceptable salt thereof in an amount suitable for producing a substantially protective action against peripheral neuropathies induced by the administration of said anticancer agent.    
   
   
       23 . The kit according to  claim 22 , wherein said anticancer agent is selected from the group of platin compounds, taxanes, epothilone class and vinca alkaloids, farnesyl transferase inhibitors, thalidomide, 5-fluorouracil, cryptophycin analogues, proteasome inhibitors.  
   
   
       24 . The kit according to  claim 23 , wherein said anticancer agent is selected from the group consisting of Carboplatin, Oxaliplatin, Docetaxel, Epothilone, Vinorelbine, Vincristine, the farnesyl transferase inhibitor R11577, thalidomide, the cryptophycin analogue LY355703, the proteasome inhibitor PS341.  
   
   
       25 . The kit according to  claim 22 , wherein said pharmacologically acceptable salt of acetyl L-carnitine is selected from the group consisting of chloride, bromide, orotate, acid aspartate, acid citrate, acid phosphate, fumarate and acid fumarate, maleate and acid maleate, acid oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate.  
   
   
       26 . The kit according to  claim 22 , wherein a further carnitine or a pharmaceutically acceptable salt thereof is added.  
   
   
       27 . The composition according to  claim 22 , wherein a further anticancer agent is added.