By: Nivaj Haque; PharmD Candidate c/o 2027

Recent advancements in cardiology have revolutionized the management of arrhythmias, offering new hope for patients with conditions like supraventricular tachycardia (SVT). Supraventricular tachycardia (SVT) significantly affects patients’ lives, leading to approximately 50,000 emergency department visits annually in the United States.¹ This statistic underscores the urgency of developing effective management strategies to prevent disruptions to patients’ daily activities, reduce the emotional and physical toll of recurring episodes, and improve their overall quality of life. These episodes, while often benign, can cause significant symptoms such as palpitations, dizziness, chest discomfort, and, in severe cases, hemodynamic instability. For patients with recurrent or severe SVT, these symptoms can interfere with daily life and pose a risk of complications, emphasizing the need for safe and effective treatment options tailored to individual patient needs.² 

Standard guidelines from leading organizations such as the American Heart Association (AHA) and the European Society of Cardiology (ESC) emphasize the use of beta-blockers, calcium channel blockers, and catheter ablation for managing SVT.³ Beta-blockers are often the first-line pharmacological therapy due to their ability to reduce heart rate and suppress arrhythmias. However, traditional beta-blockers like propranolol and metoprolol have a broad mechanism of action, affecting not only the heart but also other systems, leading to side effects such as bronchospasm, fatigue, and hypotension.⁴ This systemic impact limits their use in certain patient populations, particularly critically ill patients who require precise and rapid control of heart rate with minimal adverse effects.  

A recent breakthrough in SVT management is the FDA approval of landiolol hydrochloride (Rapiblyk), a highly cardioselective beta-1 adrenergic blocker developed by AOP Orphan Pharmaceuticals. On November 14, 2024, the FDA approved Rapiblyk for the treatment of perioperative and ICU-related SVT, marking a significant milestone for patients requiring precision therapy.⁵ This approval adds a crucial option to the arsenal of treatments available for SVT, addressing limitations seen with conventional therapies.  

Landiolol is distinguished by its ultra-short half-life, high beta-1 selectivity, and rapid onset of action. These features make it particularly suitable for use in critically ill patients who may require minute-to-minute adjustments in therapy to manage their cardiac conditions effectively.⁶ Its high cardioselectivity minimizes the risk of bronchospasm and other systemic effects associated with non-selective beta-blockers, providing a safer profile for patients with coexisting conditions such as asthma or chronic obstructive pulmonary disease (COPD). Additionally, landiolol’s ultra-short half-life (approximately 4 minutes) allows for quick cessation of its effects if adverse reactions occur, providing clinicians with greater control over therapy.⁶

The drug is administered as an intravenous infusion, with a recommended initial dose of 1 µg/kg/min, titrated based on the patient’s heart rate and hemodynamic response.⁷ Adverse events associated with landiolol are rare but may include hypotension, bradycardia, and, in isolated cases, cardiac arrest. These potential risks highlight the importance of close monitoring during administration, particularly in settings such as the ICU or operating room where patients may have compromised cardiovascular status.  

The pivotal approval of Rapiblyk was based on data from a multicenter, double-blind, randomized trial evaluating the safety and efficacy of landiolol in 200 patients with perioperative or ICU-related SVT. The study reported an 85% success rate in heart rate control within 20 minutes of administration, compared to 45% in the placebo group (p < 0.001).⁸ Patients receiving landiolol also demonstrated faster resolution of arrhythmias, fewer episodes of hemodynamic instability, and a reduction in the need for secondary interventions, such as electrical cardioversion. ⁹

An exploratory analysis of the trial further highlighted the tolerability of landiolol, particularly in patients with compromised cardiac function. Patients with reduced ejection fraction (LVEF <40%) experienced no significant adverse effects, underscoring its safety in high-risk populations.¹⁰ This finding is particularly noteworthy as traditional beta-blockers are often contraindicated or used cautiously in patients with heart failure or reduced cardiac output due to their potential to worsen hemodynamics.  

The approval of Rapiblyk represents a valuable tool for managing SVT, particularly in perioperative and critical care settings. Its unique pharmacokinetic and pharmacodynamic properties enable targeted heart rate control with minimal side effects, addressing a critical gap in current therapeutic options. Furthermore, its rapid onset and offset of action make it an ideal choice for managing acute arrhythmias in dynamic clinical situations, such as during surgery or in unstable ICU patients.  

As landiolol becomes integrated into clinical practice, further real-world studies will elucidate its long-term benefits and optimal use across various patient populations. These studies may also provide insights into its potential applications in other cardiac arrhythmias or conditions requiring precise heart rate management. The approval of Rapiblyk not only marks a step forward in arrhythmia management but also reflects a broader commitment within the field of cardiology to develop therapies tailored to the nuanced needs of diverse patient populations.  

The addition of landiolol to the treatment landscape underscores the ongoing evolution of precision medicine in cardiology, offering hope to patients and clinicians alike. Its introduction as a highly targeted beta-1 blocker reaffirms the importance of innovation in addressing unmet clinical needs and improving patient outcomes in complex cardiovascular conditions.  

References 

1. Murman DH, McDonald AJ, Pelletier AJ, Camargo CA. U.S. Emergency Department Visits for Supraventricular Tachycardia, 1993-2003. Academic Emergency Medicine. 2007;14(6):578-581. doi:https://doi.org/10.1197/j.aem.2007.01.013 
2. Mayo Clinic. Supraventricular Tachycardia – Symptoms and Causes. Mayo Clinic. Published April 30, 2022. https://www.mayoclinic.org/diseases-conditions/supraventricular-tachycardia/symptoms-causes/syc-20355243 
3. Blomström-LundqvistC, Scheinman MM, Aliot EM, et al. ACC/AHA/ESC Guidelines for the Management of Patients With Supraventricular Arrhythmias—Executive Summary. Circulation. 2003;108(15):1871-1909. doi:https://doi.org/10.1161/01.cir.0000091380.04100.84 
4.  Beta-Blockers. Physiopedia. Accessed November 22, 2021. https://www.physio-pedia.com/Beta-Blockers 
5. U.S. FDA approves AOP Health’s Rapiblyk^TM. AOP Health. Published 2024. Accessed December 21, 2024. https://www.aop-health.com/global_en/press/press-releases/us-fda-approves-rapiblyk/ 
6. Floria M, Alexandru Florinel Oancea, Paula Cristina Morariu, et al. An Overview of the Pharmacokinetics and Pharmacodynamics of Landiolol (an Ultra-Short Acting β1 Selective Antagonist) in Atrial Fibrillation. Pharmaceutics. 2024;16(4):517-517. doi:https://doi.org/10.3390/pharmaceutics16040517 
7. Part 6: Advanced Cardiovascular Life Support. Circulation. 2000;102(suppl_1). doi:https://doi.org/10.1161/circ.102.suppl_1.i-129 
8. Landiolol Approved for Critical Care Treatment of Supraventricular Tachycardia. Rare Disease Advisor. Published December 5, 2024. Accessed December 21, 2024. https://www.rarediseaseadvisor.com/news/landiolol-approved-treatment-supraventricular-tachycardia/ 
9. von Haehling S, Bělohlávek J, Er F, Gassanov N, Guarracino F, Bouvet O. Landiolol for rate control management of atrial fibrillation in patients with cardiac dysfunction. European Heart Journal Supplements. 2018;20(suppl_A):A19-A24. doi:https://doi.org/10.1093/eurheartj/sux035 
10. Levy B, Slama M, Lakbar I, et al. Landiolol for Treatment of New-Onset Atrial Fibrillation in Critical Care: A Systematic Review. Journal of Clinical Medicine. 2024;13(10):2951. doi:https://doi.org/10.3390/jcm13102951 

Published by Rho Chi Post