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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: dronedarone
* Drug: sotalol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dronedarone|Pharmaceutical form is tablet and route of administration is oral|
|Drug: sotalol|Pharmaceutical form is tablet and route of administration is oral|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of participants with ventricular proarrhythmia |  | As reported in studies included in the systematic review up to 10 years | 
| Number of all-cause mortality events |  | As reported in studies included in the systematic review up to 10 years | 
| Number of cardiovascular mortality events | includes arrhythmia-related mortality | As reported in studies included in the systematic review up to 10 years | 
| Number of participants with atrial fibrillation (AFib) recurrence |  | As reported in studies included in the systematic review up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with myocardial infarction |  | As reported in studies included in the systematic review up to 10 years | 
| Number of participants with stroke |  | As reported in studies included in the systematic review up to 10 years | 
| Number of participants with heart failure hospitalization |  | As reported in studies included in the systematic review up to 10 years | 
| Number of participants with AFib hospitalization |  | As reported in studies included in the systematic review up to 10 years | 
| 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 |