Method for treating or preventing thrombosis using dabigatran etexilate or a salt thereof with improved safety profile over conventional warfarin therapy

Abstract

A method for preventing stroke in a patient suffering from atrial fibrillation, wherein the patient has at least one risk factor for major bleeding events, the method comprising administering to the patient 110 mg b.i.d. of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

1 .- 9 . (canceled) 
     
     
         10 . A method for reducing error and increasing safety in administering a dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to a patient for (1) prevention of stroke in said patient suffering from atrial fibrillation, wherein the patient has at least one risk factor for major bleeding events, (2) prevention of stroke in a patient having at least one stroke, thrombosis, or embolism risk factor and reduction of risk of a major bleeding event or mortality compared to conventional warfarin therapy, (3) prevention or treatment of thrombosis in said patient, wherein said patient is not suitable for conventional warfarin therapy, or (4) reduction of risk of a major bleeding event, hemorrhagic stroke, intracranial stroke or mortality compared to conventional warfarin therapy in said patient comprising:
 (a) confirming that a prescribed capsule contains 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining a unique color-coding of the capsule; and   (b) administering to the patient a capsule of 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.   
     
     
         11 . The method according to  claim 10 , further comprising the steps of:
 (c) monitoring the patient for bleeding adverse events;   (d) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if no bleeding adverse events occur;   (e) confirming that a prescribed capsule containing a higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the higher dose; and   (f) administering to the patient a capsule of the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.   
     
     
         12 . The method according to  claim 10 , further comprising the steps of:
 (c) monitoring the patient for bleeding adverse events;   (d) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if bleeding adverse events occur;   (e) confirming that a prescribed capsule containing a lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the lower dose; and   (f) administering to the patient a capsule of the lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.   
     
     
         13 . A method for reducing error and increasing safety in administering a dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to a patient for prevention of stroke in said patient suffering from atrial fibrillation comprising:
 (a) determining whether the patient has at least one risk factor for major bleeding events;   (b) prescribing a capsule containing 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to the patient with at least one risk factor for major bleeding events;   (c) confirming that a prescribed capsule contains 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining a unique color-coding of the capsule; and   (d) administering to the patient a capsule of 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.   
     
     
         14 . The method according to  claim 13 , further comprising the steps of:
 (e) monitoring the patient for bleeding adverse events;   (f) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if no bleeding adverse events occur;   (g) confirming that a prescribed capsule containing a higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the higher dose; and   (h) administering to the patient a capsule of the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.   
     
     
         15 . The method according to  claim 13 , further comprising the steps of:
 (e) monitoring the patient for bleeding adverse events;   (f) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if bleeding adverse events occur;   (g) confirming that a prescribed capsule containing a lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the lower dose; and   (h) administering to the patient a capsule of the lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.   
     
     
         16 . The method according to  claim 10 , wherein the administration is either q.d. or b.i.d. 
     
     
         17 . The method according to  claim 10 , wherein the unique color-coding of the 110 mg dose capsule is a light blue opaque cap and a light blue opaque body. 
     
     
         18 . The method according to  claim 11 , wherein the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, is 150 mg. 
     
     
         19 . The method according to  claim 18 , wherein the unique color-coding of the 150 mg dose capsule is a light blue opaque cap and a cream opaque body. 
     
     
         20 . The method according to  claim 13 , wherein the risk factor is selected from the group consisting of:
 (a) having an age of at least 75 years;   (b) having a history of stroke;   (c) having a history of a transient ischemic attack;   (d) having a history of a thromboembolic event;   (e) having left ventricular dysfunction;   (f) having an age of at least 65 years and having high blood pressure;   (g) having an age of at least 65 years and having diabetes;   (h) having an age of at least 65 years and having coronary artery disease;   (i) having an age of at least 65 years and having peripheral artery disease;   (j) having a history of earlier bleeding events; and   (k) having a reduced creatine clearance less than 80 mL/minute.   
     
     
         21 . The method according to  claim 13 , wherein the step of determining a risk factor is performed through standard or specialized medical procedures. 
     
     
         22 . The method according to  claim 11 , wherein the monitoring occurs over a period of at least 3 months. 
     
     
         23 . The method according to  claim 13 , wherein the administration is either q.d. or b.i.d. 
     
     
         24 . The method according to  claim 13 , wherein the unique color-coding of the 110 mg dose capsule is a light blue opaque cap and a light blue opaque body. 
     
     
         25 . The method according to  claim 14 , wherein the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, is 150 mg 
     
     
         26 . The method according to  claim 25  wherein the unique color-coding of the 150 mg dose capsule is a light blue opaque cap and a cream opaque body. 
     
     
         27 . The method according to  claim 14 , wherein the monitoring occurs over a period of at least 3 months.