Diagnosis and Management of Infantile Hemangioma

studies of nadolol and atenolol. No harms were observed in four small studies of timolol. We
considered SOE to be low for lack of association of timolol with harms.
Detailed Analysis
Propranolol Versus Placebo or Observation
One good quality RCT conducted in 56 centers in 16 countries randomized 460 infants with a
proliferating IH measuring at least 1.5 cm in diameter to treatment with either placebo twice
daily for 6 months (n=55) or one of four oral propranolol treatment regimens (1 mg/kg/day of
propranolol divided twice daily for 3 months (n= 99) or 6 months (n= 103); 3 mg/kg/day of
propranolol divided twice daily for 3 months (n= 101) or 6 months (n= 102). 92 Two independent,
trained, validated readers centrally assessed digital photographs taken at each patient’s 15 study
visits for complete or nearly complete resolution, hemangioma evolution, and change in
hemangioma size and color. Investigators at each site performed these same assessments, and
assessed complications, adverse events, and use of other treatment for IH. Parents or guardians
also assessed changes in IH since the previous visit.
Overall, 61 of 101 patients (60%) assigned to propranolol 3mg/kg/day for 6 months and 2 of
55 patients (4%) assigned to placebo had complete or near complete resolution of hemangioma at
week 24 (p