Investigators from multiple institutions conducted a randomized controlled non-inferiority trial comparing propranolol and atenolol in the management of infantile hemangiomas (IH). Patients seen at 1 of 6 tertiary referral centers in China were eligible if they were 5-20 weeks old and had IH that required systemic therapy (IH with a diameter of ≥1.5 cm on the face, ≥3 cm outside of the face, or ≥1.5cm in any location if ulcerated). Patients with a contraindication to a β-blocker or who had been previously treated with IH therapies were excluded. Demographics and clinical characteristics (eg, IH location, size) were collected at baseline. Participants were randomized 1:1 to receive either 6 months of oral propranolol or atenolol. Dosages were adjusted for weight weekly or monthly. Treatments were tapered or discontinued if IH resolved before month 6. The primary outcome was any IH response at 6 months, defined as complete (no redundant tissue or telangiectasia identified), nearly complete (minimal degree of telangiectasias, erythema, and skin thickening), or partial (size reduction or change in color) response. A secondary outcome was hemangioma activity score (HAS), a measure of the IH proliferative activity (higher scores representing high proliferative activity), measured at baseline, and 1, 4, 12, and 24 weeks post-intervention. Adverse events were monitored and classified as serious if they involved persistent hypotension, bradycardia, or central nervous-system-related adverse effects. Investigators performed an intention-to-treat analysis to assess the effect of the treatment group on outcomes.
There were 377 participants enrolled, with 190 in the propranolol group and 187 in the atenolol group. Demographics and clinical characteristics were balanced across treatment groups. The most common location of IH among participants was the headface area (52.8%). There was no significant difference in the proportion of participants with any IH response at 6 months across treatment groups (93.7%, propranolol group vs 92.5%, atenolol group; difference, 1.2%; 95% CI, -4.1%, 6.6%). There was no significant difference in HAS scores between the 2 groups at any time-point. The frequency of adverse events was significantly higher in the propranolol (vs atenolol) group (70% vs 44.4%; difference, 25.6%; 95% CI, 15.7%, 34.8%), though there was no significant difference in the frequency of serious adverse events.
The authors conclude that atenolol is as effective as propranolol in treatment of IH and is better tolerated.
Dr Chung has disclosed no financial relationship relevant to this commentary, which does not contain a discussion of an unapproved/investigative use of a commercial product/device.
IH, the most common vascular neoplasm, occur in 4% to 5% of infants, with a 1.4 to 3:1 ratio among females to males.1 The most rapid growth of IH occurs between 1 and 3 months of age.2 Most IH will self-resolve. It is recommended that high-risk (eg, segmental, ulcerative,...