NEW YORK (Reuters Health) – The beta-blocker propranolol is superior to traditional first-line oral corticosteroids in the treatment of infantile hemangiomas (IHs), conclude pediatric dermatologists from Miami, Florida.
Their conclusion is based on a multicenter retrospective chart review of 110 patients with IH located primarily on the head and neck that were treated at University of Miami and Miami Children’s Hospital. The study appears in the August 15 issue of Archives of Dermatology.
“Our study addressed several unanswered questions regarding propranolol’s efficacy and safety for treating IH in a larger pediatric population without underlying cardiac abnormalities,” study author Dr. Carol Lattouf noted in an email to Reuters Health.
“Propranolol was more effective in IHs clearance, required fewer surgical referrals after treatment, and demonstrated superior tolerance with minimal side-effects. No major side effects occurred in our patients. In addition, propranolol was more cost-effective with a greater than 50% cost reduction per patient,” she noted.
Of the 110 patients studied, 68 received propranolol (daily cumulative dose 2 mg/kg/day) for an average of 7.9 months and 42 received oral corticosteroids (2 to 4 mg/kg/day) for 5.2 months on average.
The clinicians say 82% of infants (56 of 68) treated with propranolol had tumor clearance of 75% or more compared with 29% of infants (12 of 42) treated with oral corticosteroids (P < 0.01).
The outcome in the propranolol group did not seem to be greatly affected by previous oral corticosteroid therapy, the researchers note. It also didn’t seem to matter whether treatment was administered during the proliferative phase of IH, as outcomes were similar in patients treated with propranolol before and after 1 year of age.
“This finding indicates that propranolol’s long-term effect is not solely related to its antiproliferative effect on the vasculature but is also due to its apoptosis and vasoconstriction,” the researchers say.
Side effects were more common with corticosteroids than with propranolol (P < 0.01). In the propranolol group, 1 patient had hypoglycemia and 2 had a nonspecific skin eruption that was not associated with propranolol therapy. In contrast, all 42 infants treated with corticosteroids had 1 or more side effect.
Two of 68 patients treated with propranolol had a relapse after the drug was discontinued, but both patients responded to reinitiation of the drug.
Eight patients in the propranolol group (12%) required referral to a surgeon for treatment compared with 12 (29%) in the corticosteroid group (P < 0.01).
Until recently, corticosteroids have been the mainstay of treatment for IHs, Dr. Lattouf and colleagues note in their report. Only in complicated or refractory cases have other treatment modalities, like propranolol, been considered.
However, since 2008, several reports have demonstrated the effectiveness of propranolol for IH.
For example, clinicians from France reported in May of this year that 37 of 39 children with IH of the head and neck responded “dramatically” to propranolol (or acebutolol) within 2 days to 2 weeks. Not only did the lesions become smaller, but they also flattened and became lighter. (See Reuters Health May 17, 2011 report: Propranolol a good first-line therapy for infantile hemangioma).
Given the mounting evidence of safety and clinical efficacy, propranolol “should be considered a first-line” therapy for IH, Dr. Lattouf and colleagues conclude.
It’s also less extensive, they note. In their study, the average cost of oral corticosteroids per IH treated was $416 compared with $205 for propranolol. The propranolol cost, however, does not include a pediatric cardiology consult for cardiac clearance to initiate therapy.
Arch Dermatol 2011.