Matthew Garrett, PharmD candidate 2015
Mercer University College of Pharmacy
Infantile hemangioma are benign growths of vascular neoplasms that develop on the skin in the early stages of infancy. The majority of infantile hemangiomas do not require medical or surgical intervention.1 Propranolol is a non-selective beta-blocker and has been approved by the Food and Drug Administration for the treatment of infantile hemangioma.2
|Title: A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma|
|Design||Multicenter, randomized, double-blind, adaptive, phase 2–3 trial|
|Objective||Efficacy of propranolol in infantile hemangioma|
|Study groups||Placebo, propranolol 1mg/kg/day for 3 months, propranolol 1mg/kg/day for 6 months, propranolol 3mg/kg/day for 3 months, propranolol 3mg/kg/day for 6 months|
|Methods||For this study 460 patients underwent randomization. Patients participated in the following 15 visits: at screening; baseline (day 0); days 7, 14, and 21; and weeks 5, 8, 12, 16, 20, 24, 36, 48, 72, and 96. Infants were randomly assigned to receive placebo or one of four
propranolol regimens. A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis
|Duration||24 weeks||Primary Outcome Measure||The primary outcome was success or failure of trial treatment at week 24 versus baseline according to centralized evaluation.|
|Baseline Characteristics||Patients were 35 to 150 days of age and had proliferating infantile hemangioma requiring systemic therapy.|
|Results||At the end of the study, 61 of 101 patients (60%) assigned to the selected propranolol regimen and 2 of 55 patients (4%) assigned to placebo had successful treatment at week 24 (P<0.001).|
|Adverse Events||Common Adverse Events: diarrhea 17%, sleep disorder 10%, agitation 12%|
|Serious Adverse Events: hypotension 2%, bronchospasms 2%, bradycardia 1%|
|Percentage that Discontinued due to Adverse Evens: 29%|
|Study Author Conclusions||Oral propranolol 3mg/kg/day for 6 months is effective in the treatment of infantile hemangioma.|
There is very little literature on propranolol use in infantile hemangioma. This study aimed to improve the literature and show that propranolol 3mg/kg/day for 6 months is the most effective regimen.
1. Medscape. Infantile Hemangioma. 2015. Available at: http://emedicine.medscape.com/article/1083849-overview. Accessed February 2. 24, 2015.
2. Propranolol Oral: MedlinePlus Drug Information. Nlm.nih.gov 2015. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682607.html. Accessed February 23, 2015.
3. Léauté-labrèze C, Hoeger P, Mazereeuw-hautier J, et al. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015;372(8):735-46.