CLINICAL TRIALS PROFILE FOR BETAPACE AF

All Clinical Trials for BETAPACE AF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00589303 ↗	AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study	Terminated	Medtronic	Phase 3	2007-12-01	The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).
NCT00589303 ↗	AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study	Terminated	Mayo Clinic	Phase 3	2007-12-01	The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	Abbott Medical Devices	N/A	2006-09-01	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	Duke Clinical Research Institute	N/A	2006-09-01	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	St. Jude Medical	N/A	2006-09-01	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00578617 ↗	Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial	Completed	Mayo Clinic	N/A	2006-09-01	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00392106 ↗	High Intensity Focused Ultrasound (HIFU) Ablation System Study	Suspended	ProRhythm, Inc.	Phase 3	2006-04-01	The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.

Clinical Trial Conditions for BETAPACE AF

Condition Name

Condition Name for BETAPACE AF
Intervention	Trials
Atrial Fibrillation	4
Arrhythmia	1
Heart Failure	1
Ventricular Tachycardia	1

Condition MeSH

Condition MeSH for BETAPACE AF
Intervention	Trials
Atrial Fibrillation	4
Heart Failure	1
Tachycardia, Ventricular	1
Tachycardia	1

Clinical Trial Locations for BETAPACE AF

Trials by Country

+

−

Trials by Country for BETAPACE AF
Location	Trials
United States	33
Czech Republic	1
China	1
Canada	1

Trials by US State

+

−

Trials by US State for BETAPACE AF
Location	Trials
Maryland	3
Pennsylvania	3
Ohio	3
California	2
Minnesota	2

Clinical Trial Progress for BETAPACE AF

Clinical Trial Phase

Clinical Trial Phase for BETAPACE AF
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
N/A	2

Clinical Trial Status

Clinical Trial Status for BETAPACE AF
Clinical Trial Phase	Trials
Terminated	2
Completed	1
Suspended	1

Clinical Trial Sponsors for BETAPACE AF

Sponsor Name

Sponsor Name for BETAPACE AF
Sponsor	Trials
Duke Clinical Research Institute	2
Mayo Clinic	2
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	1

Sponsor Type

Sponsor Type for BETAPACE AF
Sponsor	Trials
Other	7
Industry	5

BETAPACE AF: Clinical Trials, Market Analysis, and Projections

Introduction

BETAPACE AF, containing the active ingredient sotalol hydrochloride, is a medication used to maintain normal sinus rhythm and delay the recurrence of atrial fibrillation (AFIB) and atrial flutter (AFL). Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Electrophysiological Effects

Clinical trials have demonstrated that BETAPACE AF exhibits both Class II (beta-blockade) and Class III (antiarrhythmic) electrophysiological effects. These effects include increased sinus cycle length, decreased AV nodal conduction, and increased refractory periods of atrial and ventricular muscle and conduction tissue[1][2].

Efficacy in AFIB/AFL

In a pooled clinical trial population consisting of four placebo-controlled studies, BETAPACE AF was shown to prolong the time to the first symptomatic, ECG-documented recurrence of AFIB/AFL. The 120 mg dose was more effective than the 80 mg dose, although the 160 mg dose did not provide additional benefits. These studies indicated that BETAPACE AF reduced the risk of recurrence at both 6 and 12 months[1].

Safety and Adverse Events

The trials also highlighted the safety profile of BETAPACE AF. However, there were instances of proarrhythmia, including Torsade de Pointes, particularly at higher doses (above 320 mg/day). The incidence of Torsade de Pointes was significantly lower in patients receiving total daily doses of 320 mg or less[1].

Pediatric and Special Populations

In a multicenter trial involving children with supraventricular and ventricular tachyarrhythmias, BETAPACE AF was administered in ascending doses. The study showed dose-related increases in the QTc interval, but the drug was generally well-tolerated in this population[1].

Intravenous Sotalol Loading

The DASH-AF trial explored the feasibility and safety of intravenous sotalol loading for rapid initiation of oral therapy in patients with atrial arrhythmias. This study found that IV sotalol loading was safe and effective compared to traditional oral dosing, allowing for quicker discharge and monitoring via mobile cardiac outpatient telemetry[5].

Market Analysis

Current Market

The global market for atrial fibrillation therapeutics has been growing steadily. As of 2015, the annualized market revenue for AF therapeutics was significant, and forecasts indicated continued growth through 2025. BETAPACE AF, being a key player in this market, benefits from this trend[3].

Treatment Usage Patterns

The treatment usage patterns for AFIB/AFL have shifted towards more effective and safer therapies. BETAPACE AF, with its dual-action mechanism, has been a preferred choice for maintaining sinus rhythm and preventing recurrence of atrial arrhythmias. This preference is reflected in its market share and usage patterns[3].

Competitive Landscape

The market for AFIB/AFL treatments is competitive, with several drugs and therapies available. However, BETAPACE AF's unique dual-action mechanism and established efficacy make it a strong contender. The market analysis suggests that BETAPACE AF will continue to hold a significant position in the treatment landscape for atrial fibrillation[3].

Projections

Market Growth

The global AF therapeutics market is projected to continue growing through 2025, driven by increasing prevalence of atrial fibrillation, advancements in treatment options, and improved diagnostic techniques. BETAPACE AF is expected to benefit from this growth, maintaining its market share and potentially expanding it as more patients are diagnosed and treated for AFIB/AFL[3].

Cost of Therapy

The annual cost of therapy for AFIB/AFL is expected to rise, but BETAPACE AF remains a cost-effective option compared to some newer therapies. This cost-effectiveness, combined with its proven efficacy, is likely to sustain its market position[3].

Future Research Directions

Future clinical trials and research may focus on optimizing dosing regimens, particularly for intravenous loading, and exploring the use of BETAPACE AF in combination with other therapies. These advancements could further enhance the drug's safety and efficacy profile, contributing to its continued market relevance[5].

Key Takeaways

• Efficacy: BETAPACE AF is effective in maintaining sinus rhythm and delaying the recurrence of AFIB/AFL.
• Safety: The drug has a well-documented safety profile, although higher doses can increase the risk of proarrhythmia.
• Market Position: BETAPACE AF holds a significant position in the AF therapeutics market and is expected to continue growing.
• Future Directions: Ongoing research, including intravenous loading and combination therapies, will likely enhance the drug's profile.

FAQs

Q: What are the primary indications for BETAPACE AF?

A: BETAPACE AF is indicated for the maintenance of normal sinus rhythm and the delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)[2].

Q: What are the Class II and Class III electrophysiological effects of BETAPACE AF?

A: Class II effects include increased sinus cycle length and decreased AV nodal conduction, while Class III effects include prolongation of atrial and ventricular monophasic action potentials and refractory period prolongation[1][2].

Q: What are the common adverse events associated with BETAPACE AF?

A: Common adverse events include proarrhythmia, such as Torsade de Pointes, particularly at higher doses, and other cardiac-related side effects[1].

Q: How does the market for AF therapeutics look for BETAPACE AF?

A: The market is projected to grow through 2025, with BETAPACE AF expected to maintain its significant market share due to its efficacy and cost-effectiveness[3].

Q: What future research directions are anticipated for BETAPACE AF?

A: Future research may focus on optimizing dosing regimens, including intravenous loading, and exploring combination therapies to enhance safety and efficacy[5].

Sources

1. FDA Label: BETAPACE AF (sotalol HCl) - AccessData FDA.
2. FDA Label: BETAPACE (sotalol HCl) - AccessData FDA.
3. Atrial Fibrillation – Global Drug Forecast and Market Analysis to 2025 - GlobalData.
4. Update on Atrial Fibrillation - Penn Medicine.
5. Feasibility and Safety of Intravenous Sotalol Loading in Adult Patients with Atrial Fibrillation/Flutter - Journal of the American College of Cardiology.