Abstract
BackgroundDespite not being licensed for the treatment of infantile hemangiomas (IH) in infants younger than 5 weeks or older than 5 months, propranolol is often used in these age groups to prevent or to treat potentially severe complications. The objective of the present study was to review the experience of 8 Italian pediatric and dermatologic centers regarding propranolol treatment for IH started before 5 weeks or after 5 months of age.MethodsWe retrospectively reviewed the records of patients followed up for IH, on propranolol treatment started before 5 weeks or after 5 months of age, and collected information on sociodemographic data, treatment indications, IH involution, IH relapse, and treatment side effects.ResultsA total of 343 patients were enrolled; 15 were started on propranolol before 5 weeks (group 1), 328 were started after 5 months of age (group 2). The most frequent indications were permanent aesthetical disfigurement (91.8%) and function threatening complications (42.6%).In most cases, the treatment was effective. The involution was partial in 67.7% of patients. In 11.8% of cases a relapse was observed. No relapse was observed in group 1. Treatment complications were reported in 15.8% of children, most frequently sleep disorders (6.6%), followed by irritability (5.1%) and diarrhea (2.2%). Only a case of mild constipation was observed in group 1.ConclusionThe safety and effectiveness profile of propranolol in infants younger than 5 weeks or older than 5 months may be acceptable. Taking in account propranolol's potential in preventing severe complications, further studies should assess the acceptability of propranolol treatment, especially in the <5-week age group .
Highlights
Despite not being licensed for the treatment of infantile hemangiomas (IH) in infants younger than 5 weeks or older than 5 months, propranolol is often used in these age groups to prevent or to treat potentially severe complications
We retrospectively reviewed the records of patients followed up for IH in the participating centers between June, 2008 and June, 2015, who had been treated with oral propranolol started before 5 weeks or after 5 months of age, and who had discontinued the treatment for at least one month
With the present descriptive study, we show that the off-label use of oral propranolol for IHs in infants, with treatment start before 5 weeks or after 5 months of age, may have an acceptable profile of effectiveness and safety
Summary
Despite not being licensed for the treatment of infantile hemangiomas (IH) in infants younger than 5 weeks or older than 5 months, propranolol is often used in these age groups to prevent or to treat potentially severe complications. The objective of the present study was to review the experience of 8 Italian pediatric and dermatologic centers regarding propranolol treatment for IH started before 5 weeks or after 5 months of age. The natural history of IHs is characterized by an onset within the first weeks of life, followed by a proliferative phase with rapid growth, generally lasting until 5 months of age; in some cases, the proliferative phase may last up to 10-11 months [6]. In 10-15% of cases, a treatment is required, with the following indications: life threatening complications, function threatening complications, ulceration not responding to local treatments, pain and potential permanent disfigurement [6, 9,10,11,12,13,14,15].
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