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

Sanofi87,810 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

87,810

Conditions

Atrial Fibrillation

Interventions

dronedaroneDRUG

Pharmaceutical form is tablet and route of administration is oral

sotalolDRUG

Pharmaceutical form is tablet and route of administration is oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Sanofi-Aventis, France

Chilly-Mazarin, France

Outcomes

Primary Outcomes

Number of participants with Cardiovascular (CV) hospitalization

CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke