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

Author:

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

Abstract

Abstract Background 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. Methods and results 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. Conclusion 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. Graphical Abstract

Funder

Bundesministerium für Bildung und Forschung

Deutsche Herzstiftung

Braukmann-Wittenberg-Herzstiftung

Medizinische Hochschule Hannover (MHH)

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine,General Medicine

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