Adverse drug events that occur following eltrombopag treatment differ between different age groups, found a new study published in the journal Clinical Pharmacology and Therapeutics.
This finding suggests that “patients of different age groups should be evaluated for different risks before applying eltrombopag,” according to the authors.
Eltrombopag sold under the brand name Promacta is an oral small-molecule thrombopoietin receptor agonist that was initially approved for use in adults with immune thrombocytopenia (ITP), among others. Then, its use gradually expanded to children. However, little is known about the drug’s overall safety among different age groups, the researchers noted.
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In the present study, a team of researchers from China analyzed the clinical features of adverse drug events associated with the use of the treatment in different age groups. The team used individual case safety reports from the US Food and Drug Administration Adverse Event Reporting System database and World Health Organization database VigiBase between 2008 and 2022. They also conducted a meta-analysis of data from randomized clinical trials published up until July 28, 2022.
The researchers conducted disproportionality analyses by age group. First, they divided patients into 2: children and adults. Then, they further divided the children into 3 groups: those who were 0 to 23 months of age, those who were 2 to 11 years of age, and those who were 12 to 17 years of age. They also divided the adults into 2 groups: those who were 18 to 64 years of ages, and those who were 65 years of age and over.
They found that adverse drug events, including subcutaneous tissue disorders, skin, hepatobiliary disorders, thrombosis, and infections, occurred differently between different age groups.
The results of their meta-analysis showed that there were differences in 4 system organ classes between children and adults with the disease. These were infections and infestations, general disorders and administration site conditions, skin and subcutaneous tissue disorders, and investigations.
The researchers also saw signals of elevated aspartate aminotransferase, alanine aminotransferase, and blood bilirubin levels in patients of all ages. While they saw signals of urinary tract infections and back pain in children only.
“Due to the inherent limitations of pharmacovigilance studies, more experiments are needed to assess the risks of eltrombopag in different ages,” they concluded.
Qu H, Wu J, Ma C, et al. Safety profile of eltrombopag in different age groups: an analysis of real-world pharmacovigilance and randomized clinical trials. Clin Pharmacol Ther. Published online April 23, 2023. doi:10.1002/cpt.2918