Udenafil Composition for Fontan Circulation and Single Ventricle Function
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Solution Overview
Problem
There is a need for new pharmacotherapies to improve exercise performance, single ventricular performance, and myocardial performance index (MPI) in single ventricle heart disease (SVHD) patients, including Fontan patients, to address complications such as reduced cardiac output, elevated venous pressure, and diminished exercise capacity, as current treatments are lacking.
Innovation Solution
Administering udenafil or a pharmaceutically acceptable salt thereof to SVHD patients, including Fontan patients, to improve MPI, ventricular performance, and exercise capacity by enhancing systolic and diastolic function, cardiac output, and reducing venous pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current treatments are used for single ventricle heart disease patients, then the treatment regimen is simple, but exercise performance, single ventricular performance, and myocardial performance index are not improved
Solution Approach 1:
The patent applies parameter changes by introducing udenafil, a PDE5 inhibitor, which changes the pharmacological parameters of the treatment regimen. This drug specifically targets phosphodiesterase type 5 to enhance cGMP signaling, thereby improving myocardial relaxation and diastolic function without requiring complex procedural interventions. The parameter change from conventional therapy to PDE5 inhibition resolves the contradiction by providing measurable improvements in exercise performance and MPI while maintaining a relatively simple oral medication regimen.
2Productivity
If conventional therapy is administered, then treatment simplicity is maintained, but cardiac output remains reduced and venous pressure remains elevated
Solution Approach 1:
The patent employs an intermediary mechanism by using udenafil as a pharmacological mediator that acts on the cGMP-PKG signaling pathway. This intermediary approach allows the drug to indirectly improve cardiac output by enhancing nitric oxide-mediated vasodilation and improving myocardial relaxation, rather than requiring direct mechanical or surgical intervention. The intermediary pharmacological action effectively increases cardiac output while avoiding complex procedural treatments.
3Reliability
If no pharmacotherapy is available for SVHD, then treatment complexity is low, but exercise capacity and myocardial performance index are diminished
Solution Approach 1:
The patent applies parameter changes by introducing udenafil, a PDE5 inhibitor, which changes the pharmacological parameters of the treatment regimen. This drug specifically targets phosphodiesterase type 5 to enhance cGMP signaling, thereby improving myocardial relaxation and diastolic function without requiring complex procedural interventions. The parameter change from conventional therapy to PDE5 inhibition resolves the contradiction by providing measurable improvements in exercise performance and MPI while maintaining a relatively simple oral medication regimen.
Data Source
AI summary
Various methods and compositions for treating single ventricle heart disease (SVHD) patients, including patients who have undergone Fontan surgery and who have Fontan circulation (Fontan patient), to improve exercise performance, single ventricular performance, cardiac output and myocardial performance index (MPI) in the SVHD patients, including the Fontan patients, using udenafil compositions.In one exemplary embodiment, the methods of the present invention include administering an effective amount of udenafil or a pharmaceutically acceptable salt thereof to a SVHD patient, including a Fontan, to improve the ventricular performance of the SVHD patient's, including the Fontan patient's, single functioning ventricle.In another exemplary embodiment, the methods of the present invention include administering an effective amount of udenafil or a pharmaceutically acceptable salt thereof to a SVHD patient, including a Fontan patient, to improve the SVHD patient's, including the Fontan patient's, MPI.In still another exemplary embodiment, the methods of the present invention include administering an effective amount of udenafil or a pharmaceutically acceptable salt thereof to a SVHD patient, including a Fontan patient, to improve the SVHD patient's, including the Fontan patient's, cardiac output.In yet another exemplary embodiment, the methods of the present invention include administering an effective amount of udenafil or a pharmaceutically acceptable salt thereof to a SVHD patient, including a Fontan patient, who is about 6 years of age or older, to improve at least one or more or all of the following in the SVHD patient, including the Fontan patient: (a) ventricular performance of the SVHD patient's, including a Fontan patient's, single functioning ventricle as measured by MPI; (b) exercise capacity as measured by oxygen consumption at anaerobic threshold (VAT); (c) exercise capacity as measured by oxygen consumption at maximal effort or max VO2; (d) work rate at VAT; (e) VE/VCO2 at VAT; diastolic blood pressure at rest; and (g) oxygen saturation (%) at rest.