Why the study?
Is oral propranolol safe for the treatment of infantile hemangioma in children <3 years of age?
Is oral propranolol safe for the treatment of infantile hemangioma in children <3 years of age?
Oral propranolol demonstrates a good safety profile in healthy children with infantile hemangioma, though cardiovascular events are more frequent in those with underlying congenital heart disease.
Supports monitoring for cardiovascular events in children with underlying disease; leaves open need for randomized safety trials in infantile hemangioma.
OBJECTIVES: The safety of oral propranolol for infantile hemangioma has not yet been studied at population level since the pediatric use marketing authorization was obtained in Europe. METHODS: = 269). RESULTS: In all, 1753 patients <3 years of age had at least 2 deliveries of oral propranolol. In the healthy population, we observed 2 cardiovascular events (SMR = 2.8 [0-6.7]), 51 respiratory events (SMR = 1.7 [1.2-2.1]), and 3 metabolic events (SMR = 5.1 [0-10.9]). In the population with an underlying disease (mainly congenital heart disease), we observed 11 cardiovascular events leading to an SMR of 6.0 (2.5-9.6). SMRs were not significantly raised for respiratory or metabolic events in this "nonhealthy" population. CONCLUSIONS: In this study on a large continuous nationwide claims database, we confirm the safety profile of oral propranolol in healthy children to be good.
No takes yet. Share an insight, caveat, or question.
Droitcourt et al. (2018) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: