Journal-based CME Course: Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma

Activity ID

9241

Expires

January 4, 2025

Format Type

Journal-based

CME Credit

1

Fee

$30

CME Provider: JAMA Pediatrics

Description of CME Course

Importance  Propranolol for infantile hemangiomas (IH) has been shown to be effective and relatively safe. However, other less lipophilic β-blockers, such as nadolol, may be preferable in individuals who experience propranolol unresponsiveness or adverse events.

Objective  To document the noninferiority and safety of oral nadolol compared with oral propranolol in infants with IH.

Design, Setting, and Participants  This 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.

Interventions  Oral propranolol and nadolol in escalating doses up to 2 mg/kg per day.

Main Outcomes and Measure  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.

Results  The study included 71 patients. Of these, 36 were treated with propranolol. The mean (SD) age in this group was 3.1 (1.4) months, and 31 individuals (86%) were female. Thirty-five infants were treated with nadolol. The mean (SD) age in this group was 3.2 (1.6) months, 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.

Conclusions and Relevance  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.

Trial Registration  ClinicalTrials.gov Identifier: NCT02505971

Disclaimers

1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

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