What is the recommended dosing of sotalol (beta blocker and antiarrhythmic) for rhythm control in older adults with impaired renal function?

From the Guidelines

Sotalol dosing for rhythm control in older adults with impaired renal function should be carefully adjusted based on creatinine clearance, with a recommended starting dose of 80 mg once daily for patients with a creatinine clearance of 30-60 mL/min, titrated cautiously to 80 mg twice daily if needed and tolerated, as supported by the 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation 1. When considering rhythm control in older adults with sotalol, several key factors must be taken into account to minimize risks and maximize benefits. The patient's renal function, as indicated by creatinine clearance, plays a crucial role in determining the appropriate dose of sotalol.

• For patients with a creatinine clearance of 30-60 mL/min, the initial dose should be 80 mg once daily.
• For those with more severe renal impairment (creatinine clearance 10-30 mL/min), the dose should be reduced to 80 mg every 48 hours.
• Sotalol is generally not recommended for patients with creatinine clearance below 10 mL/min due to the increased risk of adverse effects. Before initiating sotalol therapy, it is essential to assess baseline ECG, electrolytes, and renal function.
• QT interval monitoring is critical because sotalol can prolong the QT interval, increasing the risk of torsades de pointes, particularly in older adults with renal impairment.
• Potassium and magnesium levels should be normalized before starting treatment and maintained within the normal range to reduce the risk of arrhythmias. Dose titration should occur in a monitored setting, preferably with telemetry for at least 3 days when initiating therapy or increasing doses, to promptly identify and manage any adverse effects.
• This cautious approach is necessary because sotalol's half-life is significantly prolonged in renal impairment, increasing the risk of adverse effects including bradycardia and proarrhythmia, as noted in the guidelines for the management of patients with atrial fibrillation 1.

From the FDA Drug Label

The starting dose of Sotalol AF is 80 mg twice daily (BID) if the creatinine clearance is >60 mL/min, and 80 mg once daily (QD) if the creatinine clearance is 40 to 60 mL/min. If the creatinine clearance is <40 mL/min Sotalol AF is contraindicated. The dose of Sotalol AF must be individualized according to calculated creatinine clearance In patients with a creatinine clearance >60 mL/min Sotalol AF is administered twice daily (BID) while in those with a creatinine clearance between 40 and 60 mL/min, the dose is administered once daily (QD).

The recommended dosing of sotalol for rhythm control in older adults with impaired renal function is as follows:

• If the creatinine clearance is >60 mL/min, the starting dose is 80 mg twice daily (BID).
• If the creatinine clearance is 40 to 60 mL/min, the starting dose is 80 mg once daily (QD).
• If the creatinine clearance is <40 mL/min, sotalol is contraindicated. It is essential to monitor QT intervals and adjust the dose accordingly to minimize the risk of proarrhythmic events 2 2.

From the Research

Rhythm Control in Older Adults with Sotalol

• The recommended dosing of sotalol for rhythm control in older adults with impaired renal function is not explicitly stated in the provided studies.
• However, it is known that sotalol is a beta blocker and antiarrhythmic that can be used for rhythm control in patients with atrial fibrillation 3.
• A study published in 2021 found that outpatient initiation of sotalol was effective and safe in select patients with cardiac implantable electronic devices (CIEDs) for continuous remote monitoring and surveillance capabilities 3.
• The study used a median dose of 80 mg twice daily, with a mean dose of 105 ± 42 mg in patients who maintained sinus rhythm 3.
• Another study published in 2001 noted that sotalol is moderately effective in maintaining sinus rhythm in patients with chronic atrial fibrillation, but its safety in patients with impaired renal function is poorly understood 4.
• The risk of torsades de pointes (TdP) with sotalol increases with renal dysfunction, highlighting the need for careful dosing and monitoring in patients with impaired renal function 4, 5, 6.
• A study published in 2020 found that nonstandard dosing of sotalol was associated with a greater incidence of QTc prolongation and more frequent therapy modification 5.
• A 2024 study found that patients with heart failure with preserved ejection fraction (HFpEF) had an increased risk of QT interval prolongation associated with dofetilide and sotalol, highlighting the need for careful consideration of dosing in this population 6.
• A comparative effectiveness study published in 2016 found that sotalol was associated with less atrial fibrillation recurrence compared to dronedarone, but the study did not specifically address dosing in older adults with impaired renal function 7.