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[Podcast] An Overview of the Sotalol IV PEAKS Registry

The Sotalol IV Podcast

Description

We continue our conversation with T. Jared Bunch, MD, focusing on the Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry. Bunch highlights the value the new data has in understanding typical IV Sotalol patients, evaluating practice patterns across the country, and the impact the registry alongside existing modeling data has on the future of diagnosing arrhythmias.

About Dr. Eva Nelson: 

Eva Nelson, MD, RPh is AltaThera Pharmaceuticals’ Director of Education and Training. She has decades of experience as a physician, anesthesiologist, healthcare advocate, and educator.

About Dr. Jared Bunch

T. Jared Bunch, M.D. is currently the section chief of electrophysiology at the University of Utah and is the Jerry and Barbara Stringfellow Professor of Medicine. A graduate of the University of Utah School of Medicine, Dr. Bunch completed his internal medicine residency and fellowships in cardiovascular diseases and electrophysiology at the Mayo Clinic and served as an Assistant Professor of Medicine at the Mayo Clinic from 2003-08. He joined the cardiovascular team at Intermountain Heart Institute in 2008, directed heart rhythm research and served as medical director of heart rhythm services from 2010-19. The recipient of numerous accolades throughout his esteemed career, Dr. Bunch was an Affiliated Clinical Associate Professor for Stanford University from 2015-19 while at Intermountain.  With an interest in heart rhythm treatments and outcomes, he has published over 220 manuscripts, 13 book chapters, and 40 editorial comments.

Dr. Bunch specializes in the diagnosis and management of heart rhythm disorders.  He performs a broad range of procedures including endocardial and epicardial catheter ablation, insertion of implantable loop recorders, leadless and traditional pacemakers, subcutaneous and traditional implantable cardioverter defibrillators, and biventricular ICDs and pacemakers.  He has extensive ablation experience in treatment of abnormal heart rhythms including supraventricular tachycardia, atrial fibrillation, Wolff-Parkinson-White syndrome, ventricular tachycardia, ventricular fibrillation, and premature ventricular contractions.

References

  1. Wang Y, Zhu H, Madabushi R, Liu Q, Huang SM, Zineh I. Model-Informed Drug Development: Current US Regulatory Practice and Future Considerations. Clin Pharmacol Ther. 2019 Apr;105(4):899-911. doi: 10.1002/cpt.1363. Epub 2019 Mar 1. PMID: 30653670.
  2. Sotalol IV [package insert]. Chicago, IL: AltaThera Pharmaceuticals; 2023. sotaloliv.com/pi
  3. BetaPace [package insert]. Zug, Switzerland: Covis Pharma; 2023.
  4. Somberg JC, Vinks AA, Dong M, Molnar J. Model-Informed Development of Sotalol Loading and Dose Escalation
    Employing an Intravenous Infusion. Cardiol Res. 2020;11(5):294-304. doi:10.14740/cr1143
  5. Steinberg BA, Holubkov R, Deering T, et al. Expedited Loading with Intravenous Sotalol is Safe and Feasible – Primary
    Results of the Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry. Heart Rhythm. Published online
    February 26, 2024. doi:10.1016/j.hrthm.2024.02.046
  6. Varela DL, Burnham TS, T May H, et al. Economics and outcomes of sotalol in-patient dosing approaches in patients
    with atrial fibrillation. J Cardiovasc Electrophysiol. 2022;33(3):333-342. doi:10.1111/jce.15342
 
SIV-POD-002.2-032024

Highlights of Prescribing Information

Boxed Warning, Indications, and Important Safety Information

WARNING: LIFE THREATENING PROARRHYTHMIA

Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. To minimize the risk of drug induced arrhythmia, initiate or uptitrate intravenous sotalol in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
Do not initiate intravenous sotalol therapy if the baseline QTc is longer than 450 ms. If the QTc prolongs to 500 ms or greater, reduce the dose or discontinue. (2.3)