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Neonatal Intensive Care Drug Manual
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| bet | 174/654 | | Sana | 03.01.2022 | | Hajmi | 1,5 Mb. | | #14803 |
Evidence summary
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Efficacy
Heart failure: Digoxin has traditionally been used in the setting of atrial fibrillation and advanced heart failure. In a systematic review of the effects on total mortality in patients with systolic heart failure, digoxin did not reduce all-cause and heart failure mortality but did reduce heart failure symptoms and readmissions for heart failure by 32% (OR 0.68, 95% CI 0.61–0.75, P <0.00001). Benefits appeared greater in patients with severely reduced ejection fraction (≤25%) or NYHA III–IV functional class. Post-hoc subgroup analyses by serum digoxin concentrations (SDC) found patients within the range 0.5–0.8 ng/mL had their risk of all-cause mortality reduced by 20% (HR 0.80, 95% CI 0.68–0.94, P = 0.005). Increased arrhythmic complications have been identified in patients with SDC concentrations ≥1.2 ng/mL. If used in the context of any renal impairment, digoxin requires very careful dose and level monitoring to prevent toxicity.[1, 2]
In a systematic review of RCTs of digoxin therapy for cor pulmonale in adult patients, 4 studies with only 76 patients were included and found overall there was no statistically significant improvement in RVEF, exercise capacity, NYHA class, heart failure score or body weight.[3]
However, there are no RCTs comparing digoxin versus placebo or other drug therapy in infants with heart failure. Digoxin has been a component of standard treatment in several trials of other drug therapy in paediatric populations with heart failure in the context of congenital heart disease [4-7] and dilated cardiomyopathy [8, 9]. One of these trials, Buchhorn et al 2001 in an RCT of propranolol and standard therapy versus standard therapy alone (digoxin and diuretics) in 20 infants with congenital heart disease and left-to-right shunts reported propranolol treatment but not digoxin and diuretics alone reduced clinical symptoms of heart failure.
Recommendation: The Pediatric Cardiac Intensive Care Society 2014 Consensus Statement reported that digoxin is not currently used as a first-line therapy in the management of heart failure. Digoxin has a class IIa recommendation to potentially decrease heart failure-related admissions in adult patients with reduced left ventricular ejection fraction unless otherwise contraindicated. The current recommendations are based on results from the Digitalis Investigation Group study that showed no mortality benefit over placebo, but did document a reduction in overall hospitalizations and heart failure–related hospitalizations). Careful attention to dosing and concomitant renal dysfunction must be considered when using digoxin. Serum levels of 0.5–0.9 ng/mL are typically targeted for optimal benefit. Digoxin should be used with caution in patients receiving drugs that can affect sinoatrial or atrioventricular nodal function or therapies that may alter digoxin levels including amiodarone and/or beta blockers.[10] [LOE III-2 GOR D]
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