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Simple and safe digitoxin dosing in heart failure based on data from the DIGIT-HF trial

2023; Springer Science+Business Media; Volume: 112; Issue: 8 Linguagem: Inglês

10.1007/s00392-023-02199-z

1861-0692

Udo Bavendiek, Anika Großhennig, Johannes Schwab, Dominik Berliner, Xiaofei Liu, Lars S. Maier, Thomas Gaspar, Andreas Rieth, Sebastian Philipp, Rainer Hambrecht, Ralf Westenfeld, Thomas Münzel, Sebastian Winkler, Martin Hülsmann, Dirk Westermann, Marja Zdravkovic, Ralf Lichtinghagen, Heiko von der Leyen, Silke Zimmermann, Christian Veltmann, Michael Böhm, Stefan Störk, Armin Koch, Johann Bauersachs,

Cardiovascular Function and Risk Factors

The present study aimed to develop a simple dosing score when starting the cardiac glycoside digitoxin in heart failure with reduced ejection fraction (HFrEF) employing first data from the randomized, double-blinded DIGIT-HF trial.In DIGIT-HF, digitoxin was started with a dose of 0.07 mg once daily (o.d.) in all patients. For score derivation, 317 patients were analyzed who had been randomized to digitoxin. In these patients, after scheduled determination of serum levels at study week 6, the digitoxin dose had remained unchanged or had been reduced to 0.05 mg o.d. (97% of patients) to achieve serum concentrations within a predefined range (10.5-23.6 nmol/l). In logistic regression analyses, sex, age, body mass index (BMI), and estimated glomerular filtration rate (eGFR) were associated with need for dose reduction and, therefore, selected for further developing the dosing score. Optimal cut-points were derived from ROC curve analyses. Finally, female sex, age ≥ 75 years, eGFR < 50 ml/min/1.73 m2, and BMI < 27 kg/m2 each were assigned one point for the digitoxin dosing score. A score of ≥ 1 indicated the need for dose reduction with sensitivity/specificity of 81.6%/49.7%, respectively. Accuracy was confirmed in a validation data set including 64 patients randomized to digitoxin yielding sensitivity/specificity of 87.5%/37.5%, respectively.In patients with HFrEF, treatment with digitoxin should be started at 0.05 mg o.d. in subjects with either female sex, eGFR < 50 ml/min/1.73m2, BMI < 27 kg/m2, or age ≥ 75 years. In any other patient, digitoxin may be safely started at 0.07 mg o.d.