CLINICAL TRIALS PROFILE FOR PACERONE

All Clinical Trials for Pacerone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00300495 ↗	Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection	Terminated	Beth Israel Deaconess Medical Center	Phase 3	2006-02-01	Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
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.
NCT00587483 ↗	Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation	Completed	Mayo Clinic	N/A	2007-11-01	This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.) Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart after the aortic cross clamp is removed.

Clinical Trial Conditions for Pacerone

Condition Name

Condition Name for Pacerone
Intervention	Trials
Atrial Fibrillation	6
Heart Failure	2
Lung Cancer	1

Condition MeSH

Condition MeSH for Pacerone
Intervention	Trials
Atrial Fibrillation	8
Heart Failure	2
Sepsis	1

Clinical Trial Locations for Pacerone

Trials by Country

Trials by Country for Pacerone
Location	Trials
United States	23
Czech Republic	1
China	1
Poland	1
Canada	1

Trials by US State

Trials by US State for Pacerone
Location	Trials
Minnesota	2
Texas	2
New York	2
Massachusetts	2
Oregon	1

Clinical Trial Progress for Pacerone

Clinical Trial Phase

Clinical Trial Phase for Pacerone
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	4
N/A	1

Clinical Trial Status

Clinical Trial Status for Pacerone
Clinical Trial Phase	Trials
Terminated	3
Completed	2
Unknown status	2

Clinical Trial Sponsors for Pacerone

Sponsor Name

Sponsor Name for Pacerone
Sponsor	Trials
Mayo Clinic	2
Population Health Research Institute	1
Medtronic	1

Sponsor Type

Sponsor Type for Pacerone
Sponsor	Trials
Other	9
Industry	5
NIH	1

Clinical Trials, Market Analysis, and Projections for Pacerone (Amiodarone HCl)

Introduction to Pacerone

Pacerone, also known as Amiodarone HCl, is a potent antiarrhythmic medication used primarily for the treatment of life-threatening recurrent ventricular fibrillation and hemodynamically unstable tachycardia in adults who have not responded to other antiarrhythmic agents or cannot tolerate them[1].

Clinical Trials Experience

Adverse Reactions and Discontinuation Rates

Clinical trials and post-marketing surveillance have highlighted the significant side effect profile of Pacerone. At the usual maintenance dose of 400 mg/day and above, Pacerone causes adverse reactions in about three-fourths of all patients, leading to discontinuation in 7 to 18% of cases. Common reasons for discontinuation include pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes[1].

Specific Side Effects

• Thyroid Issues: Both hypothyroidism and hyperthyroidism are common side effects, reflecting the drug's impact on thyroid function.
• Cardiovascular: Congestive heart failure, cardiac arrhythmias, and SA node dysfunction are frequently observed.
• Pulmonary Toxicity: This is a significant concern, with rates as high as 17% and a fatality rate of about 10% in severe cases. Pulmonary toxicity can manifest as hypersensitivity pneumonitis or interstitial/alveolar pneumonitis[1].

Postmarketing Experience

Post-approval reports have identified additional adverse reactions, including hematologic issues like hemolytic anemia and agranulocytosis, immune reactions such as anaphylactic/anaphylactoid reactions, and neurologic symptoms like pseudotumor cerebri and parkinsonian symptoms[1].

Market Analysis

Current Market Position

Pacerone is a niche product within the broader cardiovascular drug market. Its use is limited to severe and life-threatening arrhythmias, which restricts its market size compared to more widely used cardiovascular medications.

Competition and Alternatives

The antiarrhythmic market is competitive, with various drugs available for different types of arrhythmias. Pacerone's unique position is its efficacy in treating life-threatening conditions that are unresponsive to other treatments. However, its side effect profile and the availability of alternative treatments can limit its market share.

Market Projections

General Trends in Cardiovascular Drugs

The global pharmaceutical market, including cardiovascular drugs, is expected to grow due to increasing R&D expenditure and outsourcing trends. However, Pacerone's market is not expected to expand significantly due to its specific and limited indications[5].

Impact of Side Effects on Market

The high rate of adverse reactions and the severity of some side effects, such as pulmonary toxicity, can deter physicians from prescribing Pacerone unless absolutely necessary. This caution can limit the drug's market growth.

No Significant Growth Expected

Given the niche nature of Pacerone and the availability of other antiarrhythmic agents, significant market growth is not anticipated. The drug will likely maintain its current market position as a last-line treatment for severe arrhythmias.

Key Takeaways

• Clinical Trials: Pacerone has a high rate of adverse reactions, leading to discontinuation in a significant percentage of patients.
• Side Effects: Pulmonary toxicity, thyroid issues, and cardiovascular problems are among the most concerning side effects.
• Market Position: Pacerone is a niche product with limited market growth potential due to its specific indications and side effect profile.
• Competition: The antiarrhythmic market is competitive, with Pacerone's use restricted to severe and life-threatening cases.

FAQs

What is Pacerone used for?

Pacerone is used for the treatment of documented, life-threatening recurrent ventricular fibrillation and hemodynamically unstable tachycardia in adults who have not responded to other antiarrhythmic agents or cannot tolerate them[1].

What are the common side effects of Pacerone?

Common side effects include pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, elevation of liver enzymes, hypothyroidism, and hyperthyroidism[1].

How often do patients discontinue Pacerone due to side effects?

Patients discontinue Pacerone due to side effects in 7 to 18% of cases[1].

Is Pacerone associated with any severe side effects?

Yes, Pacerone is associated with severe side effects such as pulmonary toxicity, which can be fatal in about 10% of cases[1].

What is the market outlook for Pacerone?

The market outlook for Pacerone is stable but not expected to grow significantly due to its niche indications and high side effect profile[5].

Sources

1. RxList: Pacerone (Amiodarone HCl Tablets): Side Effects, Uses...
2. Drug-Dev: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
3. MMM-Online: Pipeline Report 2024: See the life-changing therapies showing...
4. JAMA Network: Prophylactic Oral Amiodarone for the Prevention of Arrhythmias That...
5. GlobeNewswire: Pharmaceutical CRO Market Report 2025-2030, Featuring...