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.
OBJECTIVE
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 microg/kg), 43 received a medium dose (250 microg/kg), and 37 received a high dose (500 microg/kg). The primary outcomes were the change in 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.


CONCLUSIONS
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 microg/kg, esmolol significantly decreased systolic blood pressure.
Tabbutt
Sarah
S
Cardiac Intensive Care Unit, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA. tabbutt@email.chop.edu
Nicolson
Susan C
SC
Adamson
Peter C
PC
Zhang
Xuemei
X
Hoffman
Marc L
ML
Wells
Winfield
W
Backer
Carl L
CL
McGowan
Francis X
FX
Tweddell
James S
JS
Bokesch
Paula
P
Schreiner
Mark
M
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001017:Aortic Coarctation / Q000503:physiopathology / Q000601:surgery*; D001794:Blood Pressure / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000209:etiology; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011183:Postoperative Complications; D011412:Propanolamines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics
D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D011412:Propanolamines; C036604:esmolol