Nadolol non inferior to propranolol for treatment of infantile hemangiomas: JAMA

Infantile hemangioma (IH) is the most common tumor that affects babies. Infantile hemangiomas are more common in girls than boys and are more common in Caucasian children. During a baby's first five months, an infantile hemangioma will grow quickly. In most cases, they stop growing and begin to shrink by the baby's first birthday. It will begin to flatten and appear less red.

A prospective study by Elena Pope, MD, MSc and team has revealed that Oral Nadolol was noninferior to oral propranolol, indicating it may be an efficacious and safe alternative in cases of propranolol unresponsiveness or adverse events, or when faster involution is required.

The findings of the study are published in JAMA Pediatrics.

The objective of the study was to document the noninferiority and safety of oral nadolol compared with oral propranolol in infants with IH.

The study was double-blind noninferiority prospective study with a noninferiority margin of 10% compared propranolol with nadolol in infants aged 1 to 6 months with problematic IH. The study was conducted in 2 academic pediatric dermatology centers in Canada between 2016 and 2020. Infants aged 1 to 6 months with a hemangioma greater than 1.5 cm on the face or 3 cm or greater on another body part causing or with potential to cause functional impairment or cosmetic disfigurement. Oral propranolol and nadolol in escalating doses up to 2 mg/kg/d. Between-group differences comparing changes in the bulk (size and extent) and color of the IH at week 24 with baseline using a 100-mm visual analog scale.

The results of the study were

• A total of 71 patients. Of these, 36 were treated with propranolol and 31 individuals (86%) were female. 35 infants were treated with nadolol and 26 individuals (74%) were female.

• The difference in IH between groups by t test was 8.8 (95% CI, 2.7-14.9) for size and 17.1 (95% CI, 7.2-30.0) for color in favor of the nadolol group, demonstrating that nadolol was noninferior to propranolol.

• Similar differences were noted at 52 weeks: 6.0 (95% CI, 1.9-10.1) and 10.1 (95% CI, 2.9-17.4) for size and color improvement, respectively.

• For each doubling of time unit (week), the coefficient of involution was 2.4 (95% CI, 0.5-4.4) higher with nadolol compared with propranolol. Safety data were similar between the 2 interventions.

Pope, and team concluded that "Oral nadolol was non inferior to oral propranolol, indicating it may be an efficacious and safe alternative in cases of propranolol unresponsiveness or adverse events, or when faster involution is required."

Reference: Pope E, Lara-Corrales I, Sibbald C, et al. Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma: A Randomized Clinical Trial. JAMA Pediatr. Published online November 08, 2021. doi:10.1001/jamapediatrics.2021.4565.