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Efficacy, safety equal for propranolol, steroid in infantile hemangioma

There were no significant differences in efficacy and safety between propranolol and steroid in treating infantile hemangioma, according to study results recently published in JAMA Dermatology. 

“After propranolol was introduced for [infantile hemangioma] treatment in 2008, it has been used worldwide because it is considered more effective and safer than steroid treatment,” researchers in Seoul, South Korea, wrote. “However, there has been limited evidence for propranolol’s efficacy and safety because of a lack of randomized clinical trials.”

The researchers conducted a clinical noninferiority study of 34 infants (19 girls; mean age, 3.3 months) who were diagnosed with infantile hemangioma between June 2013 and October 2014 at Seoul National University Hospital. The infants had normal heart function and had not received previous treatment for infantile hemangioma.

Patients were randomly assigned to either propranolol or steroid treatment. Patients in the propranolol cohort received treatment of 2 mg/kg per day, in which the patients were admitted, observed for adverse events for 3 days after beginning treatment and released and treated as outpatients for a total of 16 weeks of treatment. Patients in the steroid group were treated as outpatients with orally administered prednisolone syrup 2 mg/kg per day for 16 weeks.

Guardians for two patients in the steroid cohort withdrew their consent, and one patient in the propranolol cohort did not complete the efficacy test. Efficacy evaluation was conducted for 30 patients and safety evaluation included 33 patients.

Treatment response rates were 95.65% in the propranolol cohort and 91.94% in the steroid cohort, according to intention-to-treat analysis. With a 3.71% (95% CI, –15.43 to 22.84) difference in response rate between the two treatment groups, propranolol was classified as noninferior.

Regarding safety outcomes, there were not significant differences between the treatment cohorts, and no serious adverse events were reported.

“Our trial demonstrated that propranolol was not inferior to steroid with respect to therapeutic effects in [infantile hemangioma].” – by Bruce Thiel

Disclosure: The researchers report no relevant financial disclosures.