A new retrospective study concluded there was no significant difference between the safety profile of treprostinil sodium (Remodulin®) in pediatric and adult pulmonary arterial hypertension (PAH) populations. The results of the study conducted by Habaradas et al are being presented at the Chest 2021 Annual Meeting, which is being held virtually from October 17 to 20, 2021.
“This study provides a better understanding of Remodulin’s pediatric safety profile,” the authors stated.
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According to their findings, the most frequent adverse drug reactions (ADRs) in pediatric and adult patients were infusion site pain (23% vs 19%), diarrhea (10.7% vs 20.1%), vomiting (9.1% vs 7.9%), nausea (8.2% vs 16.8%), and headache (6.3% vs 19.9%).
The ADRs more frequently observed in pediatric patients were infusion site erythema (15.1%), pyrexia (7.9%), decreased oxygen saturation (6.0%), infusion site discharge (6.0%), dehydration (4.1%), and infusion site reaction (4.1%). These ADRs were observed in 10.2%, 3.0%, 3.0%, 2.8%, 1.7%, and 0.9% of adults, respectively.
Local reactions were more common in pediatric patients. Considering the ADRs occurring at a frequency of ≥4%, the most frequent in pediatric patients were infusion site pain (23%), infusion site erythema (15.1%), diarrhea (10.7%), infusion site swelling (10.4%), and dyspnea (7.9%), whereas the most frequent in adult patients were dyspnea (20.4%), diarrhea (20.1%), headache (19.9%), infusion site pain (19%), and nausea (16.8%).
The authors observed a fatal outcome of progressive disease in 5.7% of pediatric patients and 17.5% of adult patients.
This study included data from 6128 adults (≥18 years) and 338 children (<18 years) who were enrolled in United Therapeutics’ pharmacovigilance database. The ADRs compared between the 2 populations in this study are currently listed on the labeling for treprostinil sodium.
Treprostinil sodium infusion is used to treat patients with PAH, and it is indicated for decreasing exercise-associated symptoms. Despite its well-established safety profile in the adult population, its safety remains largely unknown in pediatric patients.
Habaradas R, Higgins A, Abdelfattah I, et al. Analysis of real-world pharmacovigilance data of parenteral treprostinil for pulmonary arterial hypertension in the pediatric vs adult population. Chest. 2021;160(4):A2248-A2249. doi:10.1016/j.chest.2021.07.1978