The safety, efficacy, and pharmacokinetics of esmolol for blood pressure control immediately after repair of coarctation of the aorta in infants and children: A multicenter, double-blind, randomized trial

Objectives: Blood pressure control is important after repair of coarctation of the aorta. We report the first prospective multi-institutional trial addressing the safety and efficacy of esmolol after repair of coarctation of the aorta in infants and children. Methods: The primary objective of this phase IIIb, multicenter, double-blind, randomized, dose-ranging trial was the efficacy of esmolol to control hypertension. Candidates included subjects younger than 6 years and weighing 2.5 kg or more who underwent surgical intervention for coarctation of the aorta and required therapy for systemic hypertension. One hundred sixteen subjects received esmolol: 36 received a low dose (125 mu g/kg), 43 received a medium dose (250 mu g/ka), and 37 received a high dose (500 mu g/kg). The primary outcomes were the change ill systolic blood pressure and the need for additional antihypertensive rescue medication 5 minutes after the initiation of esmolol. Results: All dose groups showed a significant decrease from baseline in systolic blood pressure (-9.6 +/- 16.3 mm Hg, P <.001). There were no differences in systolic blood pressure response at 5 minutes between dose groups (high, medium, or low) or age groups. The need for rescue medication at 5 minutes was not different between dose groups. All dose groups showed similar incidences of adverse events. There were no serious adverse events. Discussion: Esmolol can be administered safely to patients younger than 6 years after repair of coarctation of the aorta. In the dose range of 125 to 500 mu g/kg, esmolol significantly decreased systolic blood pressure.