Propranolol effective for infant hemangiomas

March 11, 2013

The beta-blocker propranolol has been shown to clear or mostly clear infant hemangiomas after 6 months of treatment, according to preliminary findings from a clinical trial presented at the meeting of the American Academy of Dermatology in Miami Beach, Florida.

The beta-blocker propranolol has been shown to clear or mostly clear infant hemangiomas after 6 months of treatment, according to preliminary findings from a clinical trial presented at the recent meeting of the American Academy of Dermatology in Miami Beach, Florida.

The randomized clinical trial was conducted in 15 countries and included 456 infants aged 1 to 5 months with proliferating hemangiomas. Participants were randomized to placebo or to 1 of 4 propranolol regimens: 1 mg/kg per day for 6 months, 3 mg/kg per day for 6 months, or 1 of the 2 doses for 3 months followed by placebo for another 3 months. The primary endpoint was complete or near-complete resolution of a lesion at 24 weeks; secondary endpoints were minimal telangiectasia, erythema, skin thickening, soft-tissue swelling, or anatomical distortion. A total of 319 infants completed the 6 months of the study.

Researchers found the clearance rate to be 60.4% with 24 weeks’ of continuous propranolol therapy compared with 3.6% clearance rate in the placebo group. Final analysis was based on patients randomized either to 3 mg/kg of propranolol or placebo for 6 months and clearly showed the advantage in favor of the propranolol therapy. The results exceeded what researchers had hypothesized (55% clearance rate for propranolol vs 10% for placebo).

There were no unexpected safety issues with propranolol or obvious dose-related association with adverse events.

Infantile hemangiomas are found in as many as 3% of newborns in the United States and corticosteroids historically have been first-line treatment. The researchers’ rationale for using propranolol for hemangiomas is based on the beta-blocker’s history of effectiveness in treating hypertension and other cardiovascular conditions.