Use of telmisartan for the prevention and treatment of vascular headache

Abstract

The present invention relates to a method for the prophylaxis of vascular headaches which do not originate from hypertension, especially migraine, the method comprising administration of telmisartan to a subject in need of such a treatment. The present invention relates also to a method for the prophylaxis of vascular headaches, comprising the co-administration of telmisartan in combination with other drugs suitable for migraine prophylaxis and/or acute treatment of migraine.

1 . A method for the prophylaxis of vascular headache which does not originate from hypertension, the method comprising administering a therapeutically effective amount of telmisartan to a subject in need of such a treatment.  
     
     
         2 . The method according to  claim 1 , comprising co-administering a therapeutically effective amount of telmisartan and a therapeutically effective amount of at least one other drug suitable for the prophylaxis of migraine to a person in need of such treatment.  
     
     
         3 . The method according to  claim 2 , wherein the other drug is a calcitonin gene related peptide (CGRP) antagonist or a physiologically acceptable salt thereof.  
     
     
         4 . The method according to  claim 3 , wherein the CGRP antagonist or a physiologically acceptable salt thereof is administered by intravenous or subcutaneous route in a dosage of 0.0001 to 3 mg/kg of body weight or by oral, nasal or inhalative route in a dosage of 0.1 to 20 mg/kg of body weight once, twice or thrice a day.  
     
     
         5 . The method according to  claim 3 , wherein the CGRP antagonist is 1-[N 2 -[3,5-Dibromo-N-[[4-(3,4-dihydro-2(1H)-oxochinazolin-3-yl)-1-piperidi nyl]carbonyl]-D-tyrosyl]-L-lysyl]-4-(4-pyridinyl)-piperazine or 1-[4-Amino-3,5-dibrom-N-[[4-(2,3,4,5-tetrahydro-2(1H)-oxo-1,3-benzodiazepin-3-yl)-1-piperidinyl]carbonyl]-D-phenylalanyl]-4-(1-piperidinyl)-piperidin or a physiologically acceptable salt thereof.  
     
     
         6 . The method according to  claim 2 , wherein the other drug is a triptan selected from the group consisting of almotriptan, avitriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan or a physiologically acceptable salt thereof.  
     
     
         7 . The method according to  claim 6 , wherein the triptan is administered by intravenous or subcutaneous route in a dosage of 0.0001 to 1.0 mg/kg of body weight or by oral, rectal, nasal or inhalative route in a dosage of 0.0005 to 10 mg/kg of body weight once, twice or trice a day.  
     
     
         8 . The method according to  claim 1 , wherein the telmisartan is administered by oral route in a dosage of 0.143 to 7.143 mg/kg of body weight preferably in a dosage of 0.286 to 1.429 mg/kg body weight once, twice or thrice a day.  
     
     
         9 . The method according to  claim 1 , wherein the telmisartan is administered by oral route in a dosage of 0.571 to 1.142 mg/kg body weight once, twice or thrice a day.  
     
     
         10 . The method according to  claim 1 , wherein the telmisartan is administered by parenteral route in a dosage of about 0.286 mg/kg of body weight once, twice or thrice a day.  
     
     
         11 . The method according to one or more of the  claims 1  to  8 , characterized in that the vascular headache is migraine.  
     
     
         12 . A pharmaceutical composition for the prophylaxis of vascular headache, comprising a therapeutically effective amount of telmisartan and at least one other drug used for the treatment or prevention of migraine as a combined preparation for simultaneous or sequential administration.  
     
     
         13 . The pharmaceutical composition according to  claim 12 , wherein the other drug is a calcitonin gene related peptide (CGRP) antagonist or a physiologically acceptable salt thereof.  
     
     
         14 . The pharmaceutical composition according to  claim 13 , wherein the CGRP antagonist is 1-[N 2 -[3,5-Dibromo-N-[[4-(3,4-dihydro-2(1H)-oxochinazolin-3-yl)-1-piperidinyl]carbonyl]-D-tyrosyl]-L-lysyl]-4-(4-pyridinyl)-piperazine or 1-[4-Amino-3,5-dibrom-N-[[4-(2, 3,4,5-tetrahydro-2(1H)-oxo-1,3-benzodiazepin-3-yl)-1-piperidinyl]carbonyl]-D-phenylalanyl]-4-(1-piperidinyl)-piperidin or a physiologically acceptable salt thereof.  
     
     
         15 . The pharmaceutical composition according to  claim 12 , wherein the other drug is a triptan selected from the group consisting of almotriptan, avitriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan or a physiologically acceptable salt thereof.  
     
     
         16 . The pharmaceutical composition according  claim 12 , comprising an oral single dosage unit of 10 to 500 mg of telmisartan.  
     
     
         17 . The pharmaceutical composition according  claim 12 , comprising an oral single dosage unit of 20 to 100 mg of telmisartan.  
     
     
         18 . The pharmaceutical composition according  claim 12 , comprising an oral single dosage unit of 40 to 80 mg of telmisartan.  
     
     
         19 . A kit of parts for the prophlaxis of vascular headache, comprising: 
 (a) a first containment containing a pharmaceutical composition comprising a therapeutically effective amount of telmisartan and one or more pharmaceutically acceptable diluents or carriers; and    (b) a second containment containing a pharmaceutical composition comprising at least one other drug used for the treatment and/or prevention of migraine or a physiologically acceptable salt thereof and one or more pharmaceutically acceptable diluents or carriers.    
     
     
         20 . The kit of parts according to  claim 19 , wherein the drug comprised in the second containment is a calcitonin gene related peptide (CGRP) antagonist or a physiologically acceptable salt thereof.  
     
     
         21 . The kit of parts according to  claim 20 , wherein the CGRP antagonist is 1-[N 2 -[3,5-Dibromo-N-[[4-(3,4-dihydro-2(1H)-oxochinazolin-3-yl)-1-piperidinyl]-carbonyl]-D-tyrosyl]-L-lysyl]-4-(4-pyridinyl)-piperazine or 1-[4-Amino-3,5-dibrom-N-[[4-(2,3,4,5-tetrahydro-2(1H)-oxo-1,3-benzodiazepin-3-yl)-1-piperidinyl]carbonyl]-D-phenylalanyl]-4-(1-piperidinyl)-piperidin or a physiologically acceptable salt thereof.  
     
     
         22 . The kit of parts according to  claim 19 , wherein the drug comprised in the second containment is a triptan selected from the group consisting of almotriptan, avitriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan or a physiologically acceptable salt thereof.