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Investigators from multiple institutions conducted a blinded randomized trial to compare the effectiveness and safety of nadolol and propranolol for treatment of children with infantile hemangioma (IH). Study participants were enrolled at 2 academic pediatric dermatology clinics in Canada and included infants with a corrected gestational age of 1-6 months who had a facial IH >1.5 cm or IH ≥3 cm on other parts of the body with the potential to cause functional impairment or cosmetic disfigurement. At enrollment, study patients were randomized to receive oral nadolol or propranolol. Infants in both groups were begun on 0.5 mg/kg/day, with the dose increased to a maximum of 2.0 mg/kg/d. Participants were enrolled for up to 52 weeks. At study visits, investigators, blinded to treatment group, assessed change from baseline in IH bulk and color using 100 mm visual analogue scales (VAS) that had previously been validated, with VAS scores ranging from -100, indicating increase in bulk or persistent dis-coloration, to +100, indicating complete resolution or normal skin color. The primary outcome was change in VAS scores for bulk and color at 24 weeks. A priori, it was determined that nadolol was non-inferior to propranolol if the difference in bulk and color VAS scores between groups was >-10 units. T-tests were used to compare scores between groups. Cox regression was used to compare rates of achieving 75% and 100% shrinkage of IH among children in the 2 treatment groups. Parents reported adverse events in their children, and decreases in blood pressure and blood glucose levels were assessed at study visits.
Data were analyzed on 71 patients, including 35 receiving nadolol and 36 randomized to propranolol. The mean age at enrollment was 3.2 months for those in the nadolol group and 3.1 months for infants receiving propranolol; 74% and 86%, respectively, of participants in the nadolol and propranolol groups were female. At 24 weeks, differences in VAS scores for bulk and color between children in the 2 treatment groups were 8.8 units (95% CI, 2.7, 14.9) and 17.1 units (95% CI, 7.2, 30), both in favor of nadolol and meeting the non-inferiority criteria. Time to 100% involution was significantly shorter in infants receiving nadolol than in those receiving propranolol (hazard ratio [HR], 2.1; 95% CI, 1.2, 3.7); there was not a statistically significance between groups in time to 75% involution (HR, 1.6; 95% CI, 0.9, 2.6). Adverse events were similar in the 2 groups, with no serious adverse events related to study participation reported.
The authors conclude that nadolol was non-inferior to propranolol for treatment of children with IH.
Dr Dubik has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device....
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