Abstract
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. To document the noninferiority and safety of oral nadolol compared with oral propranolol in infants with IH. 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. 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 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. 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. ClinicalTrials.gov Identifier: NCT02505971.
Highlights
Infantile hemangiomas (IHs) are the most common tumors in infancy and affect 4.5% of infants worldwide.1,2 They are benign vascular endothelial neoplasms, seen more frequently in female infants (5:1 ratio), in premature infants with a birth weight of less than 1500 g, and in twins
In June 2008, spurred by an anecdotal observation, the β-blocker propranolol was reported to be beneficial in the treatment of IHs either alone or in combination with corticosteroids
Univariable Cox proportional hazards models showed that nadolol had a 59% higher rate in achieving 75% shrinkage of IH compared with propranolol and 105% higher in achieving 100% shrinkage (HR, 2.1; 95% CI, 1.2-3.7; P = .02)
Summary
Infantile hemangiomas (IHs) are the most common tumors in infancy and affect 4.5% of infants worldwide. They are benign vascular endothelial neoplasms, seen more frequently in female infants (5:1 ratio), in premature infants with a birth weight of less than 1500 g, and in twins. Infantile hemangiomas (IHs) are the most common tumors in infancy and affect 4.5% of infants worldwide.. Infantile hemangiomas (IHs) are the most common tumors in infancy and affect 4.5% of infants worldwide.1,2 They are benign vascular endothelial neoplasms, seen more frequently in female infants (5:1 ratio), in premature infants with a birth weight of less than 1500 g, and in twins. The indications for treatment are limitation or interference with normal functions (eg, breathing, vision, and hearing), persistent or intractable ulceration, and permanent structural abnormalities resulting in cosmetically unacceptable deformities.. In June 2008, spurred by an anecdotal observation, the β-blocker propranolol was reported to be beneficial in the treatment of IHs either alone or in combination with corticosteroids.. A large international randomized clinical trial documented the efficacy and relative safety of propranolol in patients with IHs The indications for treatment are limitation or interference with normal functions (eg, breathing, vision, and hearing), persistent or intractable ulceration, and permanent structural abnormalities resulting in cosmetically unacceptable deformities. In June 2008, spurred by an anecdotal observation, the β-blocker propranolol was reported to be beneficial in the treatment of IHs either alone or in combination with corticosteroids. A large international randomized clinical trial documented the efficacy and relative safety of propranolol in patients with IHs
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