Study provides more data on propranolol for infantile hemangioma

October 6, 2014

A French research team has issued an encouraging report on a cohort of children who underwent propranolol therapy for severe infantile hemangioma.

A French research team has issued an encouraging report on a cohort of children who underwent propranolol therapy for severe infantile hemangioma.

Over the past few years, propranolol has emerged as the gold-standard treatment for infantile hemangioma, despite the fact that there’s relatively little data regarding the safety of beta-blockers for pediatric use.

In an effort to provide more data, researchers from the University of Bordeaux Segalen and pharma/cosmetics firm Laboratoire Pierre Fabre analyzed the prospective cohort of the French compassionate use program (CUP) for a new pediatric formulation of oral propranolol from 2010 to 2013. The database included patients with proliferating infantile hemangioma who required systemic therapy. Safety information was collected during intake and for two years after treatment began.

The CUP included 922 pediatric patients - 74.9 percent female - with a median age of 114 days at inclusion. Forty percent of target infantile hemangioma were ulcerated, 72.4 percent led to functional impairment and 16.2 percent were life-threatening. The median daily propranolol dosage was 2 mg/kg, and median exposure duration was 6.5 months. Propranolol was discontinued following good efficacy in 83.7 percent of the patients.

The researchers found 104 adverse events (AE) in 81 patients, with 24 patients (2.6 percent) experiencing serious adverse events (SAE). The most frequent AE (slightly more than 38 percent) were respiratory, mainly bronchiolitis and bronchitis. Other AE included sleep disorders (24.7 percent), vascular (11.1 percent) with hypotension and acrocyanosis, and digestive (11.1 percent), mainly diarrhea. Slightly more than 41 percent of all SAE were respiratory, with 16.7 percent metabolic, 12.5 percent cardiovascular and 8.3 percent peripheral vascular. Most AE were transient and allowed maintenance or reintroduction of propranolol.

According to the study, this first large cohort of children tolerated the propranolol treatment well. “However,” the authors wrote, “prescribers and caretakers must consider carefully the potential severe risk of bronchoreactivity during bronchial infection, and the risk of hypoglycemia in case of low food intake or fasting.”

The study findings were published in the September issue of the Journal of Investigative Dermatology

Related content:

FDA approves drug for infantile hemangioma

Infant's growing birthmark causes blurry vision

Hemangioma treatment must begin sooner