Simple and safe digitoxin dosing in heart failure based on data from the DIGIT-HF trial
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:112 |
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| Enthalten in: |
Clinical research in cardiology : official journal of the German Cardiac Society - 112(2023), 8 vom: 22. Aug., Seite 1096-1107 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bavendiek, Udo [VerfasserIn] |
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| Links: |
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| Themen: |
Cardiac glycosides |
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| Anmerkungen: |
Date Completed 21.07.2023 Date Revised 24.07.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s00392-023-02199-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM355912287 |
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| 100 | 1 | |a Bavendiek, Udo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Simple and safe digitoxin dosing in heart failure based on data from the DIGIT-HF trial |
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| 500 | |a Date Revised 24.07.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cardiac glycosides | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Digitoxin | |
| 650 | 4 | |a Dose titration | |
| 650 | 4 | |a Heart failure | |
| 650 | 7 | |a Digitoxin |2 NLM | |
| 650 | 7 | |a E90NZP2L9U |2 NLM | |
| 700 | 1 | |a Großhennig, Anika |e verfasserin |4 aut | |
| 700 | 1 | |a Schwab, Johannes |e verfasserin |4 aut | |
| 700 | 1 | |a Berliner, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Xiaofei |e verfasserin |4 aut | |
| 700 | 1 | |a Maier, Lars |e verfasserin |4 aut | |
| 700 | 1 | |a Gaspar, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Rieth, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Philipp, Sebastian |e verfasserin |4 aut | |
| 700 | 1 | |a Hambrecht, Rainer |e verfasserin |4 aut | |
| 700 | 1 | |a Westenfeld, Ralf |e verfasserin |4 aut | |
| 700 | 1 | |a Münzel, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Winkler, Sebastian |e verfasserin |4 aut | |
| 700 | 1 | |a Hülsmann, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Westermann, Dirk |e verfasserin |4 aut | |
| 700 | 1 | |a Zdravkovic, Marja |e verfasserin |4 aut | |
| 700 | 1 | |a Lichtinghagen, Ralf |e verfasserin |4 aut | |
| 700 | 1 | |a von der Leyen, Heiko |e verfasserin |4 aut | |
| 700 | 1 | |a Zimmermann, Silke |e verfasserin |4 aut | |
| 700 | 1 | |a Veltmann, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Böhm, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Störk, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Koch, Armin |e verfasserin |4 aut | |
| 700 | 1 | |a Bauersachs, Johann |e verfasserin |4 aut | |
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