CLINICAL TRIALS PROFILE FOR MULTAQ

All Clinical Trials for Multaq

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01026090 ↗	Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)	Terminated	Sanofi	Phase 4	2009-11-01	Primary Objective: To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF. Secondary Objectives: Main Secondary : - To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation; - To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient); - To compare the rates of early recurrences of AF between the two treatment strategies; Other secondary: - To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies; - To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies; - To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion; - To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies; - To assess whether there is a difference in quality of life between the two treatment strategies.
NCT01047566 ↗	Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)	Completed	Sanofi	Phase 4	2010-04-01	The primary objective of this study is to: Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy. The secondary objectives of this study are to compare both study arms with regard to: - Ventricular rate after 3 months - Number of registered AF episodes - Number of symptomatic AF episodes - Severity of AF and AF-like symptoms - Rate of premature study discontinuation - Number of symptomatic episodes of bradycardia - Incidence of low heart rate (<60 bpm)
NCT01070667 ↗	Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation	Unknown status	Eastbourne General Hospital	Phase 4	2010-03-01	The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.
NCT01151137 ↗	Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy	Terminated	Sanofi	Phase 3	2010-07-01	Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

Clinical Trial Conditions for Multaq

Condition Name

Condition Name for Multaq
Intervention	Trials
Atrial Fibrillation	5
Paroxysmal Atrial Fibrillation	1

Condition MeSH

Condition MeSH for Multaq
Intervention	Trials
Atrial Fibrillation	6

Clinical Trial Locations for Multaq

Trials by Country

Trials by Country for Multaq
Location	Trials
Netherlands	2
Canada	2
United Kingdom	2
Austria	1
Malaysia	1

Trials by US State

Trials by US State for Multaq
Location	Trials
New Jersey	1

Clinical Trial Progress for Multaq

Clinical Trial Phase

Clinical Trial Phase for Multaq
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Multaq
Clinical Trial Phase	Trials
Terminated	2
Completed	2
Unknown status	1

Clinical Trial Sponsors for Multaq

Sponsor Name

Sponsor Name for Multaq
Sponsor	Trials
Sanofi	5
Eastbourne General Hospital	1
University of Utah	1

Sponsor Type

Sponsor Type for Multaq
Sponsor	Trials
Industry	5
Other	4

Multaq (Dronedarone): Clinical Trials, Market Analysis, and Projections

Introduction

Multaq, also known as dronedarone, is an anti-arrhythmic drug developed by Sanofi-aventis to treat patients with non-permanent atrial fibrillation (AF) or atrial flutter (AFL). Here, we will delve into the clinical trials, market analysis, and projections for this significant therapeutic innovation.

Clinical Trials Overview

ATHENA Trial

The ATHENA trial was a landmark study that evaluated the efficacy and safety of Multaq in patients with AF or AFL. This trial involved 4,628 patients, with over 2,300 receiving Multaq on top of standard therapy. The results showed a 24% reduction in the combined endpoint of cardiovascular hospitalization or death from any cause compared to placebo, meeting the study's primary endpoint[4].

Other Clinical Trials

In addition to the ATHENA trial, Multaq was studied in several other international, multi-center, randomized clinical trials, including ANDROMEDA, EURIDIS, ADONIS, and DAFNE. These trials collectively involved nearly 6,300 patients and further supported the efficacy and safety profile of Multaq[4].

PALLAS Study

The PALLAS study, however, had a different outcome. This trial was terminated early due to a significantly higher number of cardiovascular events in the Multaq-treated group compared to the placebo group, highlighting the increased risk of serious cardiovascular events when used in patients with permanent AF[3].

Market Analysis

Global Market Forecast

The global market for atrial fibrillation therapeutics, including Multaq, has been forecasted up to 2025. According to market analysis, the AF therapeutics market is driven by the increasing incidence of atrial fibrillation, particularly in aging populations. Multaq, being one of the few new treatment options in the last twenty years, has played a significant role in this market[2].

Sales Forecasts

Global sales forecasts for Multaq indicate a steady market presence, although the drug's use is limited to specific patient populations due to safety concerns. The sales forecasts from 2015 to 2025 show a trend that reflects the drug's niche but important position in the AF treatment landscape[2].

Competitive Landscape

Multaq competes with other anti-arrhythmic and anticoagulant drugs such as Xarelto (rivaroxaban), Eliquis (apixaban), and Savaysa (edoxaban). Each of these drugs has its own strengths and weaknesses, and the market is influenced by factors such as efficacy, safety, and patient compliance[2].

Safety and Efficacy

FDA Approval and Recommendations

Multaq was approved by the FDA in July 2009 to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent AF or AFL. The FDA emphasizes the importance of following the revised drug label to ensure safe use, particularly in patients with non-permanent AF[4].

Risk Evaluation and Mitigation Strategy (REMS)

To ensure the safe use of Multaq, Sanofi-aventis developed the mPACT (Multaq Partnership for Appropriate Care and Treatment) program, a REMS that includes a communication plan for healthcare professionals, a medication guide for patients, and post-marketing surveillance[4].

Market Drivers and Barriers

Growing Incidence of Atrial Fibrillation

The incidence of atrial fibrillation is increasing globally, driven by aging populations. This trend is a significant driver for the AF therapeutics market, including Multaq. Atrial fibrillation affects about 2.5 million people in the United States and 4.5 million people in the European Union, making it a public health concern[4].

Safety Concerns

Despite its benefits, Multaq's use is limited by safety concerns, particularly the increased risk of serious cardiovascular events in patients with permanent AF. This has led to a cautious approach in prescribing the drug, which can act as a barrier to wider adoption[3].

Projections and Future Outlook

Patent Expiration

Multaq's patents are set to expire, which could lead to the introduction of generic versions of the drug. This could impact the market dynamics and pricing strategies for Multaq[5].

Market Competition

The AF therapeutics market is highly competitive, with several drugs vying for market share. Multaq's future success will depend on its ability to maintain its niche in the treatment of non-permanent AF and AFL, while navigating the competitive landscape[2].

Key Takeaways

• Clinical Trials: Multaq has shown significant efficacy in reducing cardiovascular hospitalizations in patients with non-permanent AF or AFL, as demonstrated in the ATHENA trial.
• Market Analysis: The global AF therapeutics market is driven by the increasing incidence of atrial fibrillation, with Multaq holding a specific but important position.
• Safety and Efficacy: Multaq is approved for use in non-permanent AF, with a REMS program in place to ensure safe use.
• Market Drivers and Barriers: The growing incidence of atrial fibrillation is a key driver, while safety concerns act as a barrier.
• Projections: The future outlook includes the potential impact of patent expiration and ongoing market competition.

FAQs

What is Multaq used for?

Multaq (dronedarone) is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL)[4].

What were the key findings of the ATHENA trial?

The ATHENA trial showed a 24% reduction in the combined endpoint of cardiovascular hospitalization or death from any cause in patients with AF or AFL treated with Multaq compared to placebo[4].

Why was the PALLAS study terminated?

The PALLAS study was terminated early due to a significantly higher number of cardiovascular events in the Multaq-treated group compared to the placebo group, indicating an increased risk of serious cardiovascular events in patients with permanent AF[3].

What is the mPACT program for Multaq?

The mPACT (Multaq Partnership for Appropriate Care and Treatment) program is a REMS developed to ensure the safe use of Multaq, including a communication plan for healthcare professionals, a medication guide for patients, and post-marketing surveillance[4].

When do the patents for Multaq expire?

The patents for Multaq are set to expire, which could lead to the introduction of generic versions of the drug[5].

Sources

1. Sanofi-aventis Press Release: FDA Advisory Committee Recommends Approval of Multaq.
2. GlobalData Report: Atrial Fibrillation – Global Drug Forecast and Market Analysis to 2025.
3. FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular events.
4. Sanofi-aventis Press Release: FDA Approves Multaq for Patients with Atrial Fibrillation or Atrial Flutter.
5. DrugPatentWatch: Summary for MULTAQ.

Last updated: 2025-01-07