title: Propranolol (Hemangiol) and severe infantile haemangiomas. The drug of first choice.
abstract: Haemangiomas are benign vascular tumours that generally arise in the skin during the first days of life. They usually grow for a few months before stabilising and regressing over a period of several years, sometimes leaving sequelae. Because of their size or location, some haemangiomas cause: impairment of vital functions (vision, breathing); disfigurement with major problems of self-image; painful skin ulcers; and unsightly scars. When the growth of haemangioma is likely to cause complications, treatment with oral prednisolone at a dose of 2 to 3 mg/kg per day for several months can hasten its regression but carries a risk of numerous adverse effects, including electrolyte disturbances, cardiovascular and musculoskeletal disorders, hypercorticism, behavioural disorders, immunosuppression and growth retardation. Regrowth of the haemangioma sometimes occurs after prednisolone discontinuation. Propranolol, a beta-blocker, has been authorised in the European Union for the treatment of severe infantile haemangiomas, in the form of an oral solution to be used at a dose of 3 mg/kg per day for several months. Two randomised, unblinded trials with low statistical power compared propranolol with prednisolone in respectively 19 and 30 infants treated for several months. No difference in efficacy was observed. Treatment withdrawal seemed less frequent with propranolol. Two randomised, double-blind, placebo-controlled trials tested a 6-month course of propranolol. Propranololled to tumour regression in about half of the infants in one trial but, 17 months after propranolol withdrawal, tumour regrowth occurred in about 40% of the children considered to be in clinical remission. In the other trial, the haemangiomas shrank on average by about 60% with propranolol versus 14% with placebo. The known adverse effects of propranolol differ from those of corticosteroids. They mainly consist of hypoglycaemia, bradycardia, hypotension, bronchospasm, sleep disturbances, and gastrointestinal disorders. In comparative trials, treatment discontinuation because of adverse effects appeared to be less frequent with propranolol than with prednisolone. Severe adverse effects, some of which were fatal, have been reported in infants treated with propranolol. In practice, when medication is warranted for infantile haemangioma, propranolol is the drug of first choice. Parents and healthcare professionals must monitor infants closely for adverse effects. Treatment initiation and each dose increase should take place in hospital.
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D006391:Hemangioma / Q000188:drug therapy*; D006801:Humans; D011239:Prednisolone / Q000009:adverse effects; D011433:Propranolol / Q000009:adverse effects*
chemical_list: D000319:Adrenergic beta-Antagonists; D011239:Prednisolone; D011433:Propranolol