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

Bavendiek, Udo and Grosshennig, Anika and Schwab, Johannes and Berliner, Dominik and Liu, Xiaofei and Maier, Lars and Gaspar, Thomas and Rieth, Andreas and Philipp, Sebastian and Hambrecht, Rainer and Westenfeld, Ralf and Muenzel, Thomas and Winkler, Sebastian and Huelsmann, Martin and Westermann, Dirk and Zdravkovic, Marja and Lichtinghagen, Ralf and von der Leyen, Heiko and Zimmermann, Silke and Veltmann, Christian and Boehm, Michael and Stoerk, Stefan and Koch, Armin and Bauersachs, Johann (2023) Simple and safe digitoxin dosing in heart failure based on data from the DIGIT-HF trial. CLINICAL RESEARCH IN CARDIOLOGY, 112 (8). pp. 1096-1107. ISSN 1861-0684, 1861-0692

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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 m(2), and BMI < 27 kg/m(2) 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 sensi-tivity/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/1.73m(2), BMI < 27 kg/m(2), or age =75 years. In any other patient, digitoxin may be safely started at 0.07 mg o.d. [GRAPHICS]

Item Type: Article
Uncontrolled Keywords: DIGOXIN; GLYCOSIDES; PHARMACOKINETICS; HOSPITALIZATION; GUIDELINES; REDUCTION; MORTALITY; Cardiac glycosides; Digitoxin; Heart failure; Clinical trial; Dose titration
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin II
Depositing User: Dr. Gernot Deinzer
Date Deposited: 18 Apr 2024 13:08
Last Modified: 18 Apr 2024 13:08
URI: https://pred.uni-regensburg.de/id/eprint/60841

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