METHODS OF PREVENTION AND TREATMENT OF THROMBOSIS
Provided herein are methods for preventing and treating thrombosis in critically ill patients or in a patient being admitted to an intensive care unit by administering to the patient a therapeutically effective amount of betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban.
1 . A method for the prevention or treatment of thrombosis in a critically ill patient, comprising administering to the patient a therapeutically effective amount of betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban.
2 . A method for prophylaxis of venous thromboembolism (VTE) in a patient who is admitted to an intensive care unit for an acute medical illness, wherein the method comprises administering to the patient a therapeutically effective amount of betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban.
3 . A method for prophylaxis of venous thromboembolism (VTE) in a patient being cared for in an intensive care unit comprising administering betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban to the patient.
4 . The method of claim 1 , wherein the patient is at risk of developing a venous thromboembolic disease.
5 . The method of claim 1 , wherein the patient suffers from one or more of (a) acutely decompensated heart failure, (b) acute respiratory failure, (c) acute infection without septic shock, (d) an acute rheumatic disorder or (e) cancer.
6 . The method of claim 1 , wherein the patient suffers from decreased mobility.
7 . The method of claim 1 , wherein betrixaban is administered to the patient once daily or twice daily.
8 . The method of claim 1 , wherein a pharmaceutically acceptable salt of betrixaban is administered.
9 . The method of claim 8 , wherein the pharmaceutically acceptable salt of betrixaban is a maleate salt.
10 . The method of claim 1 , wherein betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban, is administered in an amount of, or equivalent to, about 20 mg to about 80 mg of betrixaban free base per day.
11 . The method of claim 1 , wherein betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban, is administered in an amount of, or equivalent to, about 40 mg to about 80 mg of betrixaban free base per day.
12 . The method of claim 1 , wherein betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban, is administered with food.
13 . The method of claim 7 , wherein the patient receives a dose of betrixaban, or a pharmaceutically acceptable salt thereof, or a crystalline polymorph of betrixaban, or a crystalline polymorph of a pharmaceutically acceptable salt of betrixaban in an amount of, or equivalent to, about 160 mg of betrixaban free base, prior to the daily administration.
14 . The method of claim 1 , wherein the thrombosis is venous thrombosis.