Skip to main content

  • Efficacy and Safety of Propranolol for Infantile Hemangioma

    By Lynda Seminara
    Selected By: Deepak P. Edward, MD
    Add to My Bookmarks

    Journal Highlights

    JAMA Dermatology
    2017;153:529-536

    Download PDF

    Kim et al. conducted a randomized trial to assess the utility of propranolol as first-line treatment for infantile heman­gioma (IH). This agent proved nonin­ferior to prednisolone in therapeutic effect, and the drugs’ safety profiles were similar.

    The research was performed at an academic hospital in Seoul, South Ko­rea. Eligible participants for the nonin­feriority study were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not received treatment for IH. Enrollees were assigned randomly to receive pow­dered propranolol (2 mg/kg/d, divided into 3 daily oral administrations) or prednisolone syrup (1 mg/mL syrup; 2 mg/kg/d), each for 16 weeks.

    Patients in the propranolol group (n = 17) were admitted, observed for adverse effects during the first 3 days, and treated as outpatients for the remaining time. Patients in the steroid group (n = 17) were treated as outpa­tients for the entire duration of treat­ment. The primary efficacy variable was change in hemangioma volume from baseline to week 16, determined from magnetic resonance images. Adverse events (AEs) were monitored through­out the study.

    Of the 34 patients randomized (mean age, 3.3 months), 31 completed the entire study. The intent-to-treat analysis, which included multiple im­putations, showed a treatment response rate of 95.65% in the propranolol group and 91.94% in the steroid group. The difference of 3.71% indicated that propranolol was not inferior to pred­nisolone. Sensitivity analyses produced similar results. Although tumor volume reduction was greater in the propran­olol group (55.87% vs. 46.52% reduc­tion), the difference was not significant.

    After the initial dose, the following parameters were significantly lower for propranolol recipients: heart rate (131.88 bpm vs. 147.63 bpm), body temperature (36.66°C vs. 36.96°C), and blood glucose level (103 mg/dL vs. 121 mg/dL). There were no serious AEs. Two patients in the steroid group had growth disability. The rates of overall and other AEs were comparable for the 2 groups. No AE was attributed to propranolol.

    The authors concluded that pro­pranolol is not inferior to prednisolone in terms of efficacy, and they added that larger studies are warranted to validate this finding, examine costs of propranolol, and comprehensively evaluate safety.

    The original article can be found here.