Safety and tolerance of propranolol in neonates with severe infantile hemangiomas: a prospective study

Yi Ji,Liqing Qiu,Bo Xiang,Siyuan Chen,Yang Yang

doi:10.1038/s41598-017-01321-2

Abstract

Although the efficacy of propranolol for the treatment of infantile hemangiomas (IHs) has been well documented, there is a paucity of clinical data regarding the safety and tolerance of propranolol in neonates. A prospective study of 51 patients less than 30 days of age with severe IH was conducted. All patients were admitted to the hospital for monitoring during initial propranolol treatment at day 0 with dose adjustments at days 7 and 28. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), blood glucose (BG) levels and potential side effects were evaluated during treatment. There were significant decreases in mean heart rate and SBP after the initiation of propranolol therapy (P < 0.05). In contrast, no significant differences in mean DBP and BG levels were observed after each dose during hospitalization (P > 0.05). Bradycardia and hypotension were noted in at least 1 recorded instance in 11.8% and 5.9% of patients, respectively. These hemodynamic changes were not persistent and were asymptomatic. Two patients who had a history of neonatal pneumonia reported severe bronchial hyperreactivity during treatment. This study demonstrated that propranolol administered to properly selected young infants was safe and well tolerated. However, close monitoring should be considered in high-risk young patients.

Highlights

Infantile hemangiomas are the most common vascular tumor in children
Many clinicians remain cautious about the administration of oral propranolol for infantile hemangiomas (IHs), especially in young infants, because these drugs act systemically and affect the cardiovascular system
A prospective study was performed in infants with problematic IHs who were hospitalized for propranolol initiation between October 2013 and September 2015

Summary

Introduction

Infantile hemangiomas are the most common vascular tumor in children. If left untreated, the typical characteristic evolution of these tumors is rapid postnatal proliferation, stabilization and slow, spontaneous involution. The options in life-threatening cases include treatment with vincristine, interferon-α or cyclophosphamide[1] None of these therapeutic modalities is ideal due to their restrictions or potentially serious side effects, such as temporary growth retardation, increased risk of infection and behavioral changes[2, 3]. An elaborate study by Tollefson et al.[11] further demonstrated that the most dramatic growth of IHs occurs between 5.5 and 7.5 weeks, which was much earlier than previously estimated The authors of these studies suggested the need for a paradigm shift in the timing of referral and initiation of treatment for high-risk IH so that therapy can be initiated before or early during the most rapid growth, rather than after it is already completed. This prompted us to assess the safety and tolerance of propranolol in our young patients with the purpose of providing evidence-based data for future treatment recommendations

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