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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dronedarone | Drug | Pharmaceutical form is tablet and route of administration is oral |
| |
| sotalol | Drug | Pharmaceutical form is tablet and route of administration is oral |
|
| 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 |
| 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 |
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Inclusion Criteria:
Following eligibility criteria are defined to select relevant studies from the literature
Exclusion Criteria:
Exclusion criteria for potential participants are:
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Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months])
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences and Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis, France | Chilly-Mazarin | 91380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37025083 | Result | 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):589-597. doi: 10.1002/clc.24011. Epub 2023 Apr 6. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077764 | Dronedarone |
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |