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Digoxin is Not Related to Mortality in Patients with Heart Failure: Results from the SELFIE-TR Registry

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Abstract

Aims

Digoxin has been used in the treatment for heart failure for centuries, but the role of this drug in the modern era is controversial. A particular concern is the recent observational findings suggesting an increase in all-cause mortality with digoxin, although such observations suffer from biased results since these studies usually do not provide adequate compensation for the severity of disease. Using a nationwide registry database, we aimed to investigate whether digoxin is associated with 1-year all-cause mortality in patients with heart failure irrespective of phenotype.

Methods

A total of 1014 out of 1054 patients in the registry, of whom 110 patients were on digoxin, were included in the study. Multivariable adjustments were done and propensity scores were calculated for various prognostic indicators, including signs and symptoms of heart failure and functional capacity. Crude mortality, mortality adjusted for covariates, mortality in the propensity score-matched cohort, and Bayesian factors (BFs) were analyzed.

Results

Crude 1-year mortality rate did not differ between patients on and off digoxin (17.3% vs 20.1%, log-rank p = 0.46), and digoxin was not related to mortality following multivariable adjustment (hazard ratio 0.87, 95% confidence interval 0.539–1.402, p = 0.57). Similarly, all-cause mortality was similar in 220 propensity-score adjusted patients (17.3% vs 20.0%, log-rank p = 0.55). On Bayesian analyses, there was moderate to strong evidence suggesting a lack of difference between in unmatched cohort (BF10 0.091) and weak-to-moderate evidence in the matched cohort (BF10 0.296).

Conclusions

In this nationwide cohort, we did not find any evidence for an increased 1-year mortality in heart failure patients on digoxin.

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Acknowledgements

The authors thank the investigators of the original SELFIE-TR registry study.

Author information

Author notes

  1. Rengin Çetin Güvenç and Tolga Sinan Güvenç have contributed equally to the manuscript.

Authors and Affiliations

  1. Division of Cardiology, Department of Internal Medical Sciences, Istanbul Okan University School of Medicine, Tepeören Mahallesi Tuzla Kampüsü, 34959, Istanbul, Turkey

    Rengin Çetin Güvenç, Mert Efe Çağlar, Abdullah Ayar Al Arfaj & Ailin Behrad

  2. Division of Cardiology, Department of Internal Medical Sciences, Istinye University School of Medicine, Istanbul, Turkey

    Tolga Sinan Güvenç

  3. Division of Cardiology, Department of Internal Medical Sciences, Dokuz Eylul University School of Medicine, Istanbul, Turkey

    Mehmet Birhan Yılmaz

Authors
  1. Rengin Çetin Güvenç
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Corresponding author

Correspondence to Rengin Çetin Güvenç.

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Conflict of Interest

The authors have no competing interests to declare that are relevant to the content of this article. Rengin Çetin Güvenç, Tolga Sinan Güvenç, Mert Efe Çağlar, Abdullah Ayar Al Arfaj, Ailin Behrad, and Mehmet Birhan Yılmaz declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.

Funding

The authors did not receive support from any organization for the submitted work.

Ethical Standards

The study was conducted according to the principles outlined in the 1975 Declaration of Helsinki and its subsequent revisions, and all patients gave their informed consent before participating in the original registry, with no further consent sought for this particular analysis. The study was approved by an ethics committee (decision registration no. B.10.4.ISM.4.06.68.49, protocol no. 288-AU/003).

Data Availability

The authors declare that the data are available upon reasonable request.

Author Contributions

RCG: Conceptualization, design, data curation, writing, review. TSG: Conceptualization, design, methodology, analysis, writing, review. MEC: Design, data curation, writing. AAA: Conceptualization, data curation, analysis, writing. AB: Design, data curation, writing. MBY: Conceptualization, analysis, writing, review.

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Supplementary Information

Below is the link to the electronic supplementary material.

Supplemental Figure 1. Flow diagram of the study. (PDF 853 KB)

40256_2024_639_MOESM2_ESM.tiff

Supplemental Figure 2. Kaplan Meier curves for one-year survival in patients presented with acute (A) or chronic (B) heart failure at baseline. Numbers in parentheses denote confidence intervals. (TIFF 425 KB)

40256_2024_639_MOESM3_ESM.tiff

Supplemental Figure 3. Kaplan-Meier curves for one-year survival in patients presented with reduced (A) or mildly reduced / preserved (B) ejection fraction at baseline. Numbers in parentheses denote confidence intervals. (TIFF 419 KB)

40256_2024_639_MOESM4_ESM.tiff

Supplemental Figure 4. Kaplan-Meier curves for one-year survival in patients with sinus or pacemaker rhythm (A) and atrial fibrillation (B) at baseline. Numbers in parentheses denote confidence intervals. (TIFF 461 KB)

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Çetin Güvenç, R., Güvenç, T.S., Çağlar, M.E. et al. Digoxin is Not Related to Mortality in Patients with Heart Failure: Results from the SELFIE-TR Registry. Am J Cardiovasc Drugs (2024). https://doi.org/10.1007/s40256-024-00639-3

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