METHODS OF IMPROVING MYOCARDIAL PERFORMANCE IN FONTAN PATIENTS USING UDENAFIL COMPOSITIONS
The present invention relates generally to the field of using udenafil or a pharmaceutically acceptable salt thereof in patients who have undergone the Fontan operation.
31 - 68 . (canceled)
69 . A method of treating a single ventricle heart disease (SVHD) patient with udenafil, or a pharmaceutically acceptable salt thereof, to improve the SVHD patient's exercise capacity, wherein the SVHD patient has undergone Fontan palliation, the method comprising:
administering to the SVHD patient an effective daily dose of udenafil, or a pharmaceutically acceptable salt thereof, to treat the SVHD patient to improve the SVHD patient's exercise capacity,
wherein the udenafil, or a pharmaceutically acceptable salt thereof, is administered in a total daily dose of about 125 mg of udenafil, or a pharmaceutically acceptable salt thereof.
70 . The method of claim 69 , wherein the udenafil, or a pharmaceutically acceptable salt thereof, is formulated as an oral dosage form.
71 . The method of claim 70 , wherein the oral dosage form is a solid or semi-solid oral dosage form selected from a group of solid or semi-solid oral dosage forms consisting of a tablet, a capsule, a gel, a liquid dispersion, a pill, a powder, and a suspension.
72 . The method of claim 70 , wherein the oral dosage form is a tablet.
73 . The method of claim 70 , wherein the oral dosage form comprises about 125 mg of udenafil or a pharmaceutically acceptable salt thereof, and wherein the method comprises orally administering the oral dosage form to the SVHD patient once daily.
74 . The method of claim 69 , wherein the patient's exercise capacity is improved at both the patient's VO 2 max and anaerobic threshold.
75 . The method of claim 69 , wherein the SVHD patient is between about 12 years old and about 18 years old.
76 . The method of claim 75 , wherein the udenafil, or a pharmaceutically acceptable salt thereof, is formulated as an oral dosage form.
77 . The method of claim 76 , wherein the oral dosage form is a solid or semi-solid oral dosage form selected from a group of solid or semi-solid oral dosage forms consisting of a tablet, a capsule, a gel, a liquid dispersion, a pill, a powder, and a suspension.
78 . The method of claim 76 , wherein the oral dosage form is a tablet.
79 . The method of claim 76 , wherein the oral dosage form comprises about 125 mg of udenafil, or a pharmaceutically acceptable salt thereof, and wherein the method comprises orally administering the oral dosage form to the SVHD patient once daily.
80 . A method of treating a single ventricle heart disease (SVHD) patient with udenafil, or a pharmaceutically acceptable salt thereof, to improve the SVHD patient's exercise capacity, wherein the SVHD patient has undergone Fontan palliation, the method comprising:
administering to the SVHD patient an effective daily dose of udenafil, or a pharmaceutically acceptable salt thereof, to treat the SVHD patient to improve the SVHD patient's exercise capacity,
wherein the udenafil, or a pharmaceutically acceptable salt thereof, is administered in a total daily dose of about 125 mg to about 175 mg of udenafil, or a pharmaceutically acceptable salt thereof.
81 . The method of claim 80 , wherein the udenafil, or a pharmaceutically acceptable salt thereof, is formulated as an oral dosage form.
82 . The method of claim 81 , wherein the oral dosage form is a solid or semi-solid oral dosage form selected from a group of solid or semi-solid oral dosage forms consisting of a tablet, a capsule, a gel, a liquid dispersion, a pill, a powder, and a suspension.
83 . The method of claim 81 , wherein the oral dosage form is a tablet.
84 . The method of claim 81 , wherein the oral dosage form comprises about 125 mg of udenafil or a pharmaceutically acceptable salt thereof, and wherein the method comprises orally administering the oral dosage form to the SVHD patient once daily.
85 . The method of claim 80 , wherein the patient's exercise capacity is improved at both the patient's VO 2 max and anaerobic threshold.
86 . The method of claim 80 , wherein the SVHD patient is between about 12 years old and about 18 years old.
87 . A pharmaceutical composition for oral administration to a single ventricle heart disease (SVHD) patient who has undergone Fontan palliation, the pharmaceutical composition comprising:
udenafil, or a pharmaceutically acceptable salt thereof, in an amount effective to improve the SVHD patient's exercise capacity; and
a pharmaceutically acceptable excipient.
88 . The pharmaceutical composition of claim 81 , wherein the pharmaceutical composition comprises udenafil, or a pharmaceutically acceptable salt thereof in an amount of about 87.5 mg to about 125 mg.