Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05279833
• Other study ID #: CSA0010
• Status: Completed
• Start date: September 24, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87810
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Following eligibility criteria are defined to select relevant studies from the literature

• Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))

• Participants have received either Dronedarone or Sotalol

• controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies

Exclusion Criteria:

Exclusion criteria for potential participants are:

• Children/adolescents

• Permanent atrial fibrillation (AFib)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• dronedarone
Pharmaceutical form is tablet and route of administration is oral
• sotalol
Pharmaceutical form is tablet and route of administration is oral

Locations

Country	Name	City	State
France	Sanofi-Aventis, France	Chilly-Mazarin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

References & Publications (1)

Singh JP, Blomstrom-Lundqvist C, Turakhia MP, Camm AJ, Fazeli MS, Kreidieh B, Crotty C, Kowey PR. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023 Jun;46(6):589-5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Cardiovascular (CV) hospitalization	CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke	As reported in studies included in the systematic review up to 10 years
Primary	Number of participants with ventricular proarrhythmia		As reported in studies included in the systematic review up to 10 years
Primary	Number of all-cause mortality events		As reported in studies included in the systematic review up to 10 years
Primary	Number of cardiovascular mortality events	includes arrhythmia-related mortality	As reported in studies included in the systematic review up to 10 years
Primary	Number of participants with atrial fibrillation (AFib) recurrence		As reported in studies included in the systematic review up to 10 years
Secondary	Number of participants with myocardial infarction		As reported in studies included in the systematic review up to 10 years
Secondary	Number of participants with stroke		As reported in studies included in the systematic review up to 10 years
Secondary	Number of participants with heart failure hospitalization		As reported in studies included in the systematic review up to 10 years
Secondary	Number of participants with AFib hospitalization		As reported in studies included in the systematic review up to 10 years
Secondary	Number of participants with conduction disorders	Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants	As reported in studies included in the systematic review up to 10 years