The Effect of Udenafil on Heart Rate and Blood Pressure in Adolescents With the Fontan Circulation - ScienceDirect

• The exploratory component of this analysis was designed to evaluate the effect of udenafil on patients believed to be at higher risk of having an adverse hemodynamic reaction upon its initiation, including smaller patients and those already on afterload-reducing agents. Some studies of PDE-5 inhibitors have suggested an exaggerated response in patients on other afterload-reducing agents, with more pronounced changes in blood pressure.12 This was not observed in the FUEL cohort, an important finding given the prevalent use of these medications in children and adolescents with Fontan physiology.19 Similarly, the youngest and smallest patients in the cohort did not have clinically significant changes in vital signs with the introduction of udenafil. Importantly, the FUEL protocol did not specify that udenafil administration needed to be staggered with respect to other daily medications.

• In conclusion, initiation of treatment with udenafil in patients with Fontan circulation was associated with small and clinically insignificant changes in HR and BP, implying that for patients similar to those enrolled in the FUEL trial, udenafil can be initiated in the outpatient setting.

https://www.sciencedirect.com/science/article/abs/pii/S0002914923011359