Reference Laboratory Values for Digoxin Following Publication of Digitalis Investigation Group (DIG) Trial Data

Hauptman, Paul J.; McCann, Patrick J.; Romero, Jorge M. Ramirez; Mayo, Mary

doi:10.1001/jamainternmed.2013.7756

Cited by 17 publications

(12 citation statements)

References 7 publications

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“…However, dissemination of 0.5–0.9 ng/mL as the standard reference range is inconsistent; many sources still indicate 2.0 ng/mL as the upper level of the therapeutic range for serum digoxin levels [8]. Furthermore, many hospital laboratories still consider digoxin levels of 2.0 ng/mL to be within normal range [36]. Targeting the lower range would likely further reduce the number of patients who inadvertently experience digoxin toxicity from serum digoxin levels that are clearly supratherapeutic.…”

Section: Discussionmentioning

confidence: 99%

Emergency Department Visits and Hospitalizations for Digoxin Toxicity

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Shehab

Kegler

et al. 2014

Circ: Heart Failure

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Background Recent data on digoxin prescribing and adverse events are lacking but could help inform the management of digoxin in contemporary heart failure treatment. Methods and Results We determined nationally-representative numbers and rates of emergency department (ED) visits for digoxin toxicity in the United States using 2005–2010 reports from the National Electronic Injury Surveillance System—Cooperative Adverse Drug Event Surveillance project and the National Ambulatory (and Hospital Ambulatory) Medical Care Surveys. Based on 441 cases, an estimated 5,156 (95% confidence interval [CI], 2,663–7,648) ED visits for digoxin toxicity occurred annually in the United States; over three-fourths (78.8% [95% CI, 73.5%–84.1%]) resulted in hospitalization. Serum digoxin level was ≥2.0 ng/mL for 95.8% (95% CI, 93.2%–98.4%) of estimated ED visits with levels reported (n=251 cases). The rate of ED visits per 10,000 outpatient prescription visits among patients ≥85 years was twice that of patients 40–84 years (rate ratio, 2.4 [95% CI, 1.2–5.0]); among females, the rate was twice that of males (rate ratio, 2.3 [95% CI, 1.1–4.7]). Digoxin toxicity accounted for an estimated 1.0% (95% CI, 0.6%–1.4%) of ED visits for all adverse drug events (ADEs) among patients ≥40 years, but an estimated 3.3% (95% CI, 2.3%–4.4%) of ED visits and 5.9% (95% CI, 4.0%–7.9%) of hospitalizations for all ADEs among patients ≥85 years. Estimated annual ED visits and hospitalizations remained relatively constant from 2005–2010. Conclusion Digoxin toxicity is not declining; more careful prescribing to high-risk groups and improved monitoring of serum levels might be needed to reduce morbidity from outpatient digoxin use.

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Section: Discussionmentioning

confidence: 99%

Emergency Department Visits and Hospitalizations for Digoxin Toxicity

See

Shehab

Kegler

et al. 2014

Circ: Heart Failure

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“…Furthermore, a post-hoc analyses of the DIG trial revealed that compared with SDCs ≥1 ng/mL, lower SDCs between 0.5 and 0.9 ng/mL were associated with significant decrease in all-cause mortality and hospitalisations in patients with HF 14. Importantly, the reference range varies across clinical laboratories, which has important implications for potential toxity 15 16. Hence, much more supportive evidence exists for use of lower SDCs between 0.5 and 1.0 ng/mL, and while a therapeutic range of 0.8–2.0 ng/mL is still often used in practice, the updated American College of Cardiology (ACC)/American Heart Association (AHA) guidelines actually recommend therapeutic range of 0.5–1.0 ng/mL 15…”

Section: Pharmacologymentioning

confidence: 99%

Digoxin: its role in contemporary medicine

Stucky

Goldberger

2015

Postgraduate Medical Journal

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Digoxin has been a key therapeutic for heart failure and atrial tachyarrhythmias for over 200 years following Withering's groundbreaking work depicting the therapeutic benefit of the common botanical foxglove in his 1785 monograph. The use of digoxin preceded any randomised evidence or even basic understanding of its mechanism of action. Over the past two decades, there has been mounting evidence further challenging the safety and efficacy of digoxin, while multiple other therapies for both heart failure and atrial tachyarrhythmias have proven to be more effective and safe. Altogether, digoxin still has an important role in contemporary pharmacotherapeutics, though its role remains controversial and should be reserved for selective patients and clinical situations, with careful attention to serum concentrations.

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“…Further, the approved labelling for many digoxin assays still refers to this older therapeutic range. Collaboration is needed between clinicians and major laboratories to establish a new evidence‐based ‘therapeutic target’ range for heart failure …”

Section: Practical Use Of Digoxin: Successfully Targeting Serum Concementioning

confidence: 99%

A perspective on re‐evaluating digoxin's role in the current management of patients with chronic systolic heart failure: targeting serum concentration to reduce hospitalization and improve safety profile

Ghali

Patterson

Stough

et al. 2014

European J of Heart Fail

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Digoxin improves exercise tolerance and reduces hospitalizations in patients with systolic heart failure, but its use has declined progressively for the past two decades. The Digitalis Investigation Group trial showed that digoxin reduced hospitalizations but had a neutral effect on total mortality. There was evidence that mortality caused by worsening heart failure was less, but there was also a signal suggesting an increase in other cardiac (presumed arrhythmic) death. Use of digoxin has declined substantially and recent guideline recommendations have significantly de-emphasized the importance of this drug in the management of heart failure. Two developments suggest that re-evaluation of the contemporary role of digoxin in the management of heart failure with reduced ejection fraction is warranted. First, heart failure remains progressive, characterized by chronic debility, exercise intolerance, and frequent and costly hospitalizations, despite evidence-based drug and device therapies that prolong survival. Health economics have made reducing hospitalizations in patients with heart failure a major priority. Second, a strong association has emerged between serum concentration and the safety and efficacy of digoxin, which indicates a change in our approach to dosing this agent is needed. Experimental and clinical results suggest that optimizing therapeutic benefit and avoiding harm means dosing to achieve low serum digoxin concentrations (0.5-0.9 ng/mL). Digoxin is an inexpensive agent and the totality of evidence indicates that it reduces hospitalizations and improves symptoms safely when dosed to achieve low serum concentrations. These findings suggest digoxin should have a more prominent therapeutic role in patients with heart failure and reduced ejection fraction.

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Reference Laboratory Values for Digoxin Following Publication of Digitalis Investigation Group (DIG) Trial Data

Cited by 17 publications

References 7 publications

Emergency Department Visits and Hospitalizations for Digoxin Toxicity

Emergency Department Visits and Hospitalizations for Digoxin Toxicity

Digoxin: its role in contemporary medicine

A perspective on re‐evaluating digoxin's role in the current management of patients with chronic systolic heart failure: targeting serum concentration to reduce hospitalization and improve safety profile

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