Safety profile of a divided dose of propranolol for heart rate in children with infantile haemangioma during 16 weeks of treatment

BACKGROUND: Although propranolol has been accepted as a first-line drug for infantile haemangioma (IH), no study has systematically characterized changes in heart rates during long-term propranolol treatment. OBJECTIVES: To evaluate the influence of a divided dose of propranolol on heart rates in patients with IH. METHODS: A prospective study was conducted from January 2009 to December 2013. All patients with IH were administered propranolol at 0·67 mg kg(-1) per day as a single dose on days 1 and 2, gradually increased to the full dose (2 mg kg(-1) per day) on day 5, which was given in three divided doses. Heart rates were recorded before treatment and were closely monitored during treatment. Heart rates in controls were monitored once a week. RESULTS: All heart rates monitored during treatment were found to be within the normal range. Fluctuations in heart rates were observed after every dose from the first day to the first dose of the sixth day; however, from the second dose of the sixth day onwards, no significant differences in heart rates were observed after each dose on successive days. During the second week of drug therapy, no significant differences in heart rates were observed at 1 h after the first dose (P = 1·00). Also, no significant differences (P = 0·73) in heart rates were observed between patients and controls at 1 h after the first dose on Mondays from week 1 to 16 of treatment. CONCLUSIONS: A three-times-daily dosing regimen of propranolol had no significant sustained effects on heart rates in subjects with IH.