Methods of improving myocardial performance in Fontan patients using udenafil compositions
Inventors
Yeager, James L. • Goldberg, David J. • Paridon, Stephen M.
Assignees
Mezzion Pharma Co Ltd • Childrens Hospital of Philadelphia CHOP
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Publication Number
US-10653698-B2
Publication Date
2020-05-19
Expiration Date
Abstract
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.
Core Innovation
The disclosure describes treating patients born with functional single ventricle congenital heart disease who have undergone Fontan palliation by orally administering udenafil, or a pharmaceutically acceptable salt thereof, in an oral dosage form. The treatment is directed to improving the patient's exercise capacity or increasing the likelihood of improving the patient's exercise capacity, wherein exercise capacity is determined by maximum oxygen uptake at maximum exercise output (VO2 measurement).
The disclosed methods target patients whose exercise capacity is adversely affected due to a decline in heart function after Fontan palliation. The treatment regimen comprises orally administering an oral dosage form comprising an effective dose of udenafil, or a pharmaceutically acceptable salt thereof, to improve the patient's VO2 measurement or increase the likelihood of improving the patient's VO2 measurement.
The disclosure further defines that the oral dosage form comprises an effective dose and includes embodiments in which the oral dosage form is a tablet, and embodiments in which the oral dosage form is a solid or semi-solid oral dosage form selected from a listed group. The patient is a human adolescent between about 12 years old and about 18 years old, and the dosage regimen includes twice daily administration in at least one embodiment and total daily dosing from about 125 mg to about 175 mg.
Claims Coverage
The provided content includes multiple independent claims, and the core coverage centers on oral administration of udenafil (or a pharmaceutically acceptable salt) to human adolescents after Fontan palliation to improve VO2-based exercise capacity. The inventive features focus on VO2 measurement, the Fontan-palliated patient population, adolescent age range, declining heart function after Fontan palliation, and specified dosing regimens including twice daily administration and total daily dose ranges.
Oral udenafil treatment to improve VO2-based exercise capacity after Fontan palliation
A method of treating a human patient born with functional single ventricle congenital heart disease who has undergone Fontan palliation for improving the patient's exercise capacity or for increasing the likelihood of improving the patient's exercise capacity, wherein exercise capacity is determined by maximum oxygen uptake at maximum exercise output (VO2 measurement), comprising orally administering an oral dosage form comprising an effective dose of udenafil, or a pharmaceutically acceptable salt thereof, to improve the patient's VO2 measurement or to increase the likelihood of improving the patient's VO2 measurement.
Adolescent Fontan palliation with specified twice-daily udenafil dosing
The method wherein the patient is a human, wherein the patient has undergone Fontan surgery, wherein the human patient is between about 12 years old and about 18 years old, wherein the effective dose of udenafil, or a pharmaceutically acceptable salt thereof, is about 87.5 mg, and wherein the treatment regimen comprises orally administering the oral dosage form to the human adolescent twice daily.
Total daily udenafil dose range for improving VO2-based exercise capacity after Fontan palliation
A method of treating a patient born with functional single ventricle congenital heart disease who has undergone Fontan palliation for improving the patient's exercise capacity or for increasing the likelihood of improving the patient's exercise capacity, wherein exercise capacity is determined by maximum oxygen uptake at maximum exercise output (VO2 measurement), comprising orally administering an oral dosage form comprising an effective dose of udenafil, or a pharmaceutically acceptable salt thereof, wherein the patient is a human, wherein the patient has undergone Fontan surgery, wherein the human patient is between about 12 years old and about 18 years old, and wherein the total daily dose of udenafil, or a pharmaceutically acceptable salt thereof, is from about 125 mg to about 175 mg.
Udenafil administration for Fontan-palliated patients with declining heart function
A method of treating a patient born with a congenital heart defect who has undergone Fontan palliation for improving the patient's exercise capacity or for increasing the likelihood of improving the patient's exercise capacity, whose exercise capacity is adversely affected due to a decline in the patient's heart function after Fontan palliation, wherein the patient is in need of treatment to improve the patient's exercise capacity or to increase the likelihood of improving the patient's exercise capacity, wherein exercise capacity is determined by maximum oxygen uptake at maximum exercise output (VO2 measurement), comprising orally administering an oral dosage form comprising an effective dose of udenafil, or a pharmaceutically acceptable salt thereof, to improve the patient's VO2 measurement or to increase the likelihood of improving the patient's VO2 measurement.
Across the independent claims, the claim coverage is directed to oral administration of udenafil (or pharmaceutically acceptable salts) to human adolescents after Fontan palliation, with exercise capacity defined by VO2 measurement at maximum exercise output. The claims require that exercise capacity is adversely affected due to a decline in heart function after Fontan palliation and specify either an effective dose of about 87.5 mg twice daily or a total daily dosing range from about 125 mg to about 175 mg.
Stated Advantages
Improving the patient's VO2 measurement and thereby improving exercise capacity.
Increasing the likelihood of improving the patient's VO2 measurement and thereby increasing the likelihood of improving exercise capacity.
Documented Applications
Treating human adolescents about 12 to 18 years old with functional single ventricle congenital heart disease or congenital heart defect who have undergone Fontan palliation and have impaired exercise capacity, using oral udenafil to improve VO2-based exercise capacity.
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