Journal of Family Practice - Optimal digoxin range for men is 0.5 to 0.8 ng/mL
Rathore SS, Curtis JP, Wang Y, Bristow MR, Krumholz, HM. Association of serum digoxin concentration and outcomes in patients with heart failure. JAMA 2003; 289:871-878.
* PRACTICE RECOMMENDATIONS
The optimal serum drug concentration for digoxin among men in sinus rhythm with stable heart failure is 0.5 to 0.8 ng/mL. This range is associated with decreased risk of hospitalization and mortality compared with placebo. Higher levels are associated with either no reduction, or an increased risk of hospitalization and mortality compared with placebo.
* BACKGROUND
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The Digitalis Investigation Group (DIG) trial of patients with heart failure found no effect on mortality from digoxin therapy at serum concentrations of 0.5 to 2.0 ng/mL, but did find that hospitalization due to worsening heart failure was modestly reduced. The original investigators did not evaluate the relative efficacy of different concentrations.
Other studies have demonstrated an association between serum drug concentrations 4 signs or symptoms of heart failure. Other medications known to benefit heart failure, such as angiotensin-converting enzyme inhibitors and diuretics, were continued. Patients using digoxin at the time of enrollment could be allocated to drug or placebo.
* STUDY DESIGN AND VALIDITY
This study is a post-analysis of data collected from the DIG study. The DIG study was a double-blind, placebo-controlled study of digoxin in the treatment of heart failure. Digoxin dosing was based on a published algorithm; serum digoxin levels were drawn 1 month after randomization. The present study is a subgroup analysis of men based on serum drug concentrations at 1 month of 0.5-0.8 ng/mL, 0.9-1.1 ng/mL, or [greater than or equal to] 1.2 ng/mL. These ranges have been used in previous studies of digoxin in the treatment of heart failure.
The study was sufficiently well done to draw conclusions about use of digoxin in treatment of heart failure. Patients and data investigators were blinded with respect to treatment, and cause of death was determined without knowledge of assigned treatment group. Digoxin levels were reported from the 1 month visit only. No subsequent levels were documented.
Generalizability to the general population is limited, as only men with heart failure in sinus rhythm and a left ventricular ejection fraction
