A newly developed intravenous (IV) loading protocol for sotalol, “One Day Sotalol Loading Protocol” (ODSL) has been shown to be safe and feasible, with the potential to produce significant healthcare savings while also freeing up personnel and resources, according to study results presented at the American Heart Association (AHA) Scientific Sessions 2021, held from November 13 to 15, 2021.
Sotalol is a common therapy used to manage atrial arrhythmias, and it was recently approved for IV administration, according to researchers. The protocol for IV loading is based on computer-simulated plasma concentration instead of clinical data. The availability of IV sotalol produces an opportunity to shorten loading time.
For the study, researchers used the IV sotalol formulation to develop an ODSL protocol that they used for the management of atrial fibrillation (AF). Data on patients undergoing this protocol from June 2020 to December 2020 were analyzed. The primary study endpoint was the successful initiation of sotalol therapy, and the secondary study endpoint was sinus rhythm maintenance at 30 days. Safety endpoints included ventricular arrhythmias, excessive QT interval prolongation, and sinus bradycardia that required dose adjustment. Patient demographics and comorbidities were also evaluated, and a cost savings analysis was performed.
Among the 55 participants included for analysis, 30 had paroxysmal AF; 25 had persistent AF; the mean age was 70±9.82 years; 60.7% were men; the average ejection fraction was 52.91±9.25%; and the average creatinine clearance was 83.58±44.35 mL/min. Fifty-one participants (92.7%) had a successful ODSL. Of these, 6 experienced adverse events that resulted in dose reductions due to adverse events, and 7 (12.7%) experienced significant QT prolongation during loading. ODSL was terminated in 4 participants: 1 for prolonged QTc and symptomatic bradycardia, and 3 for failure of cardioversion. At 30-day follow-up, 42 (76%) of participants remained on sotalol, and 32 (58%) maintained their sinus rhythm. The ODSL allowed for same-day discharge, leading to healthcare costs being reduced by 18%.
“We present first real-world data demonstrating that abbreviated ODSL is feasible, safe, and leads to significant health care savings while freeing up resources and personnel. Further patient enrollment and data analysis [are] ongoing to further solidify this novel loading approach,” the study authors noted.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Jacobs S, Oren J, Storm R, et al. One day intravenous sotalol loading for treatment of atrial arrhythmia. Presented at: AHA Scientific Sessions 2021; November 13-15, 2021. Poster P938.