Evaluation of the Tolerability of Intermittent Intravenous Sildenafil in Pediatric Patients With Pulmonary Hypertension.

OBJECTIVES: The primary purpose of this study was to determine the tolerability of intermittent intravenous (IV) sildenafil for the treatment of pulmonary hypertension in pediatric patients. Secondary objectives were to evaluate parameters related to efficacy.
METHODS: This was a retrospective chart review from January 2013 to August 2014 of pediatric patients under age 18 years treated with intermittent doses of IV sildenafil for pulmonary hypertension. Patients were excluded if they were over age 18 years or received sildenafil for other indications. Measures collected to assess tolerability include blood pressure and heart rate before and after the administration of IV sildenafil, as well as adverse events.
RESULTS: Thirty-seven patients (21 females and 16 males) were identified meeting inclusion criteria, and 21 (56.8%) were on oral sildenafil prior to the initial IV dose. The mean decrease in blood pressure after the first dose of IV sildenafil was 7.16/2.74 mmHg. The decrease in systolic blood pressure was statistically significant. During the study period, 5 patients experienced medication related adverse events, primarily hypotension. Despite this, none of the patients had the medication discontinued due to these events. For secondary objectives, a statistically significant difference was not found between other clinical measures before and after intermittent IV sildenafil dosing.
CONCLUSIONS: Sildenafil, when administered as intermittent IV doses, was tolerated by the majority of patients evaluated in this study. For pediatric patients with pulmonary hypertension in whom enteral or continuous IV sildenafil cannot be administered, intermittent IV sildenafil may be considered as an alternative administration option.