Atrial Fibrillation
Conditions
Brief 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.
Interventions
DRUGdronedarone
Pharmaceutical form is tablet and route of administration is oral
DRUGsotalol
Pharmaceutical form is tablet and route of administration is oral
Sponsors
Sanofi
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with atrial fibrillation (AFib) recurrence | As reported in studies included in the systematic review up to 10 years | — |
| Number of participants with Cardiovascular (CV) hospitalization | As reported in studies included in the systematic review up to 10 years | CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke |
| 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 | As reported in studies included in the systematic review up to 10 years | includes arrhythmia-related mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with conduction disorders | As reported in studies included in the systematic review up to 10 years | Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants |
| 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 | — |
Countries
France
Outcome results
None listed