Safety and efficacy of digoxin: systematic review and meta-analysis of observational and controlled trial data
Why the study?
Does digoxin reduce all cause mortality and hospital admissions compared to placebo or no treatment?
Population
52 studies comprising 621,845 patients from observational and randomised controlled trials published from…
Comparison
Digoxin vs Control (placebo or no treatment)
Design
Meta-analysis
Follow-up
4,006,210 patient years of follow-up (combined total)
Authors
Discussion
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Implication
Supports digoxin for lowering admissions without mortality increase; confirms neutral death effect in RCTs while extending admission data.
Key Points
- To determine the true effect of digoxin on mortality and hospital admissions across randomized controlled trials and observational studies while accounting for confounding and study design.
- Searched Medline, Embase, Cochrane Library, and trial registries from 1960 to July 2014 (PROSPERO CRD42014010783) for trials comparing digoxin with placebo or no treatment.
- Synthesized data across 52 studies comprising 621,845 patients and 75 analyses (4,006,210 patient-years of follow-up) using random-effects meta-analysis and meta-regression stratified by study design and bias risk.
- Digoxin was associated with excess mortality in unadjusted observational studies (RR 1.76, 95% CI 1.57 to 1.97) and adjusted analyses (RR 1.61, 95% CI 1.31 to 1.97), but this attenuated in propensity-matched studies (RR 1.18, 95% CI 1.09 to 1.26) and was completely neutral in randomized controlled trials (RR 0.99, 95% CI 0.93 to 1.05).
- Digoxin treatment was associated with a significant reduction in all-cause hospital admissions across all study types (RR 0.92, 95% CI 0.89 to 0.95; P<0.001; n=29,525).
Structured PICO
Does digoxin reduce all cause mortality and hospital admissions compared to placebo or no treatment?
P
Population
52 studies comprising 621,845 patients from observational and randomised controlled trials published from 1960 to July 2014.
I
Intervention
Digoxin
C
Comparator
Control (placebo or no treatment)
O
Outcome
All cause mortalityhard clinical
Digoxin has a neutral effect on mortality in randomized trials but is associated with a lower rate of hospital admissions, suggesting that the increased mortality observed in observational studies is likely driven by prescription bias.
Limitations
- Prescription biases limit the value of observational data
Cite This Study
Ziff et al. (2015) studied this question.