Risk Prediction for Adverse Events during Initiation of Sotalol and Dofetilide for the Treatment of Atrial Fibrillation

Agusala, Kartik; Oesterle, Adam; Kulkarni, B; Caprio, Timothy; Subačius, Haris; Passman, M.S.C.E. Rod

doi:10.1111/pace.12586

Cited by 16 publications

(7 citation statements)

References 20 publications

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“…Agusala and colleagues were not able to identify any significant predictors of ADRs. The authors concluded ADRs are common during initiation and that these results establish need for close inpatient monitoring [11] .The rates of bradycardia and QT prolongation during admission in our study of renally impaired patients (15.9% and 23.1%, respectively) are lower than that reported despite twice daily dosing strategy. Furthermore, sotalol product labeling describes bradycardia incidence of 13.1% [3] .…”

Section: Original Researchcontrasting

confidence: 47%

Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review

Rabatin

et al. 2018

Journal of Atrial Fibrillation

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Background:The class III antiarrhythmic sotalol is renally eliminated with a dose-related propensity to cause adverse drug reactions (ADR) potentially leading to life-threatening arrhythmias. Although product labeling recommends once daily dosing in patients with renal impairment, twice daily dosing is commonly utilized. This study evaluates the safety of this practice. Methods:This retrospective, observational study examined renally impaired patients with atrial fibrillation or atrial flutter admitted for sotalol initiation from July 1, 2012-December 31, 2014, then for up to 20 months after initiation. Primary endpoints included rates of ADR and therapy changes due to ADR. Secondary endpoints included therapy changes due to arrhythmia recurrence, admissions due to arrhythmia recurrence, and therapy changes for any cause. Results: Analysis included 134 patients with an average creatinine clearance of 51 ml/min, followed over a median of 170 days. Length of stay averaged 3 days with ADR occurring in 53.7% of patients, most commonly QT prolongation or bradycardia. Therapy change due to ADR occurred in 45.5% of patients (n=61). Therapy change due to arrhythmia recurrence occurred in 23.1% (n=31), admission due to arrhythmia recurrence occurred in 24.6% (n=33), and therapy change for any cause occurred in 74.6%(n=100). Conclusion:Initiating sotalol twice daily in renally impaired patients results in ADR and therapy change rates consistent with rates seen in clinical practice for non-renally impaired patients, with minimal length of stay.This practice may be reasonable when initiated in the acute care setting with subsequent outpatient monitoring, however further study is needed.

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Section: Original Researchcontrasting

confidence: 47%

Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review

Rabatin

et al. 2018

Journal of Atrial Fibrillation

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“…Geographically, 12/36 studies were done in USA, multicenter studies account for 11/36 studies, one study was done in UK/France/Germany/Turkey/Greece/Taiwan/Iran, two studies were done in Switzerland. Study design distributions were: cross sectional studies in 3/36, prospective observational in 3/36, retrospective studies in 10/36 and randomized controlled trials in 19/36 ( Table 1 , [ 3 - 38 ]).…”

Section: Resultsmentioning

confidence: 99%

“…TdP was found in 49 patients (0.33 %), SCD was found in five patients and 586 were found to have all-cause mortality. Only two studies reported ventricular arrhythmias [ 3 , 36 ]; two studies reported TdP [ 9 , 19 ]; one study reported SCD [ 9 ]; and four studies reported death [ 18 - 20 , 36 ]. Remaining studies either didn’t report ventricular arrhythmias or didn’t have any episodes of ventricular arrhythmias.…”

Section: Resultsmentioning

confidence: 99%

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Impact of Drug Induced Long QT Syndrome: A Systematic Review

et al. 2018

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BackgroundDrug induced long QT syndrome is quite common in daily clinical practice but its impact is unknown.MethodsPubMed and EMBASE databases (until May 2, 2017) were searched to identify studies reporting drug induced long QT syndrome and followed the PRISMA guidelines. The main outcomes measured in these studies were QTc prolongation, ventricular arrhythmias, torsade de pointes (TdP) and death.ResultsOut of 176 non-duplicate reports, 36 studies satisfied inclusion criteria and provided data on patients exposed to drugs that can potentially cause long QT. Totally, 14,756 patients were exposed and 930 patients (6.3%) were found to have QTc prolongation. The number of males was 6,400 and females were 5,723 patients. The mean age of the patients was 43.8 ± 9.36 years. Ventricular arrhythmias were found in 379 patients (2.6%), 26 patients were found to have premature atrial contractions (PACs) and premature ventricular contractions (PVCs). TdP was found in 49 patients (0.33 %), sudden cardiac death (SCD) was found in five patients and 586 patients were found to have all-cause mortality.ConclusionsAround 6% of patients have risk of QT prolongation when exposed but only 0.3% developed TdP and 2.6% developed ventricular arrhythmias. Risk of developing arrhythmias is higher with concomitant use of multiple QT prolonging drugs.

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“…These rates are somewhat higher compared to those of similar single-center studies. 16,17 The mean maximal QTc interval during medication initiation was also higher in the nonstandard group. Additionally, it was greater than the maximum recommended QTc interval of 500 ms.…”

Section: Discussionmentioning

confidence: 90%

Assessment of Sotalol and Dofetilide Dosing at a Large Academic Medical Center

Ting

Malloy

Knowles

2020

J Cardiovasc Pharmacol Ther

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Background: Patients initiated on sotalol and dofetilide require inpatient monitoring and dose adjustments due to risks of corrected QT (QTc) prolongation and Torsades de pointes (TdP). Patients may receive higher initial doses than recommended due to close monitoring by specialized practitioners. The objective of this study was to describe prescribing practices of sotalol and dofetilide and to compare safety outcomes between standard and nonstandard dosing strategies. Methods: This was a single-center retrospective analysis of adult inpatients who underwent sotalol or dofetilide initiation between June 1, 2015, and August 1, 2018. The end points of this study included the percentage of patients who received standard and nonstandard dosing, incidence of QTc prolongation (≥500 milliseconds or ≥15% from baseline), incidence of TdP, and dose reduction or medication discontinuation. Results: A total of 379 patients (195 sotalol and 184 dofetilide) were included in this analysis. There were 110 (56.4%) patients in the sotalol group and 111 (58.4%) patients in the dofetilide group that received nonstandard initial dosing. Nonstandard dosing was associated with a greater incidence of QTc prolongation compared to standard dosing (57.5% vs 43.0%, P = .005). Only one patient in the nonstandard dosing group experienced TdP. Patients initiated on nonstandard dosing required dose reduction or therapy discontinuation (37.6% vs 23.4%, P = .003) more frequently. Conclusion: Higher than recommended initial doses of sotalol or dofetilide were associated with higher incidence of QTc prolongation and more frequent therapy modification.

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Risk Prediction for Adverse Events during Initiation of Sotalol and Dofetilide for the Treatment of Atrial Fibrillation

Abstract: In conclusion, AEs are common during DF and SL initiation but rarely severe in hospitalized inpatients. Baseline QTc predicts AEs for DF patients only and AE are common even in "low-risk" patients. These results support in-hospital drug initiation for all DF and SL patients.

Cited by 16 publications

References 20 publications

Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review

Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review

Impact of Drug Induced Long QT Syndrome: A Systematic Review

Assessment of Sotalol and Dofetilide Dosing at a Large Academic Medical Center

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