Sotalol in neonates for arrhythmias: Dosing, safety, and efficacy

Abstract

Introduction Various agents may be utilized to manage supraventricular tachycardia (SVT) in neonates and infants. Recently, sotalol has piqued interest given its reported success in managing neonates and infants with SVTs, especially with the intravenous formulation. While the manufacturer recommends using an age‐related nomogram in neonates and young infants to guide doses, clinical reports describe various dosing based on weight (mg/kg) or on body surface area (BSA) in mg/m2. Given the reported variation in clinical practice with regard to dosing in neonates, there is a gap in the literature and translation into clinical practice regarding applicability of the nomogram into clinical practice. The purpose of this study was to describe sotalol doses based on body weight and BSA in neonates for SVT. Methods This is a single center retrospective study evaluating effective sotalol dosing from January 2011 and June 2021 (inclusive). Neonates who received intravenous (IV) or oral (PO) sotalol for SVT were eligible for inclusion. The primary outcome was to describe sotalol doses based on body weight and BSA. Secondary outcomes include comparison of doses to the manufacturer nomogram, description of dose titrations, reported adverse outcomes, and change in therapy. Two‐sided Wilcoxon signed‐rank tests were used to determine statistically significant differences. Results Thirty‐one eligible patients were included in this study. The median (range) age and weight were 16.5 (1−28) days and 3.2 (1.8−4.9) kg, respectively. The median initial dose was 7.3 (1.9−10.8) mg/kg or 114.3 (30.9−166.7) mg/m2/day. Fourteen (45.2%) of patients required a dose increase for SVT control. The median dose required for rhythm control was 8.5 (2−14.8) mg/kg/day or 120.7 (30.9−225) mg/m2/day. Of note, the median recommended dose per manufacturer nomogram for our patients would have been 51.3 (16.2−73.8) mg/m2/day, which is significantly lower than both the initial dose (p < .001) and final doses (p < .001) utilized in our study. A total of 7 (22.9%) patients were uncontrolled on sotalol monotherapy using our dosing regimen. Two patients (6.5%) had reports of hypotension and one patient (3.3%) had a report of bradycardia requiring discontinuation of therapy. The average change in baseline QTC following sotalol initiation was 6.8%. Twenty‐seven (87.1%), 3 (9.7%), 1 (3.3%) experienced prolongation, no change, or a decrease in QTc, respectively. Conclusions This study demonstrates that a sotalol strategy significantly higher than the manufacture dose recommendations are required for rhythm control in neonates with SVT. There were few adverse events reported with this dosing. Further prospective studies would be advantageous to confirm these findings.

Pharmacological Management of Cardiac Arrhythmias in the Fetal and Neonatal Periods: A Scientific Statement From the American Heart Association

“…73 Nonetheless, several studies have reported that sotalol doses substantially higher than those recommended by the nomogram are safe and effective for neonates and infants with refractory supraventricular arrhythmias. 56,74…”