PURPOSE: Remodulin (treprostinil) infusion is indicated to treat pulmonary arterial hypertension (PAH) to diminish exerciseassociated symptoms. The pediatric safety profile is not established. Real-world data were analyzed for adverse drug reactions (ADR) in pediatrics versus adults.METHODS: This retrospective study compared United Therapeutics' pharmacovigilance data of pediatrics (<18 yo) versus adults ($18 yo) to determine any significant difference between the two populations. The database search ranged from 03Feb1998 to 01Sep2020 and included postmarketing surveillance and unblinded serious clinical trial reports of patients with PAH. The ADRs compared are listed events for Remodulin. The difference in ADR percentage for pediatrics versus adults, the 95% CI of the difference, and ADRs occurring at frequency of $4% were summarized.RESULTS: A total of 6,128 adults and 338 pediatric patients were analyzed. 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%) were the most frequently experienced ADRs in pediatrics and adults respectively. ADRs more frequent in pediatrics were Infusion Site Erythema (15.1% vs. 10.2%), Pyrexia (7.9% vs. 3.0%), Oxygen Saturation Decreased (6.0% vs. 3.0%), Infusion Site Discharge (6.0% vs. 2.8%), Dehydration (4.1% vs. 1.7%), and Infusion Site Reaction (4.1% vs. 0.9%). The lower bound of 95% CI of the difference for pediatrics versus adults is >0. Of ADRs occurring $4%, Infusion Site Pain (23%), Infusion Site Erythema (15.1%), Diarrhea (10.7%), Infusion Site Swelling (10.4%), and Dyspnea (7.9%) were most frequent in pediatrics, while Dyspnea (20.4%), Diarrhea (20.1%), Headache (19.9%), Infusion Site Pain (19%), and Nausea (16.8%) were most frequent in adults. A fatal outcome of progressive disease was 5.7% and 17.5% in pediatrics versus adults respectively. CONCLUSIONS: Remodulin safety profile is comparable between pediatric and adult PAH population. However, local reactions were observed more in pediatrics.
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