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Digoxin versus placebo, no intervention, or other medical interventions for atrial fibrillation and atrial flutter: a
Naqash J Sethi1, Sanam Safi2, Joshua Feinberg2
1Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. hvg658@alumni.ku.dk.
Insights
This systematic review protocol evaluates digoxin for atrial fibrillation and atrial flutter. It aims to clarify the drug
Area of Science:
- Cardiology
- Pharmacology
- Evidence-Based Medicine
Background:
- Atrial fibrillation and atrial flutter are common heart arrhythmias with increased mortality risks.
- Current evidence on digoxin's benefits and harms for these conditions is unclear.
- Heart rate control is crucial for preventing heart failure and cardiomyopathy in affected patients.
Purpose of the Study:
- To systematically review the beneficial and harmful effects of digoxin.
- To compare digoxin against placebo, no intervention, or other medical treatments.
- To inform clinical practice regarding digoxin use in atrial fibrillation and atrial flutter.
Main Methods:
- Systematic review protocol adhering to Cochrane guidelines.
- Inclusion of all relevant randomized clinical trials comparing digoxin with control or other interventions.
- Comprehensive literature search across multiple databases (CENTRAL, MEDLINE, EMBASE, etc.).
- Risk of bias assessment and meta-analysis using Review Manager and Trial Sequential Analysis.
- GRADE assessments for quality of evidence and 'Summary of Findings' tables.
Main Results:
- This section will be populated upon completion of the systematic review.
- Anticipated to identify benefits and harms of digoxin for atrial fibrillation and atrial flutter.
Conclusions:
- This systematic review will provide evidence on digoxin's efficacy and safety.
- Findings have the potential to impact millions of patients and healthcare economics.
- Results will guide clinical decision-making for managing atrial fibrillation and atrial flutter.
Background:
Atrial fibrillation is the most common arrhythmia of the heart with a prevalence of approximately 2% in the western world. Atrial flutter, another arrhythmia, occurs less often with an incidence of approximately 200,000 new patients per year in the USA. Patients with atrial fibrillation and atrial flutter have an increased risk of death and morbidities. In the management of atrial fibrillation and atrial flutter, it is often necessary to use medical interventions to lower the heart rate. Lowering the heart rate may theoretically prevent the development of heart failure and tachycardia-mediated cardiomyopathy. The evidence on the benefits and harms of digoxin compared with placebo or with other medical interventions is unclear. This protocol for a systematic review aims at identifying the beneficial and harmful effects of digoxin compared with placebo, no intervention, or with other medical interventions for atrial fibrillation and atrial flutter.
Methods:
This protocol for a systematic review was conducted following the recommendations of Cochrane and the eight-step assessment procedure suggested by Jakobsen and colleagues. We plan to include all relevant randomised clinical trials comparing digoxin with placebo, no intervention, or with other medical interventions. We plan to search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, Science Citation Index Expanded on Web of Science, and BIOSIS to identify relevant trials. Any eligible trial will be assessed and classified as either at high risk of bias or low risk of bias, and our primary conclusions will be based on trials with low risk of bias. We will perform our meta-analyses of the extracted data using Review Manager 5.3 and Trial Sequential Analysis ver. 0.9.5.5 beta. For both our primary and secondary outcomes, we will create a 'Summary of Findings' table based on GRADE assessments of the quality of the evidence.
Discussion:
The results of this systematic review have the potential to benefit millions of patients worldwide as well as healthcare economy.
Systematic Review Registration:
PROSPERO CRD42016052935.