The present systematic review and meta- analysis of all available data sources suggest that digoxin use is associated with an increased mortality risk , particularly among patients suffering from AF
There are conflicting data regarding the effect of digoxin use on mortality in patients with atrial fibrillation ( AF ) or with congestive heart failure ( CHF ) .
The aim of this meta- analysis was to provide detailed analysis of the currently available study reports .
Association of serum digoxin concentration and outcomes in patients with heart failure.
CONTEXT The Digitalis Investigation Group ( DIG ) trial reported that digoxin provided no overall mortality benefit and only a modest reduction in hospitalizations among patients with heart failure and depressed left ventricular systolic function . The clinical outcomes associated with digoxin therapy at different serum concentrations in the DIG trial have not been assessed . OBJECTIVE To assess variations in serum digoxin concentration ( SDC ) and their association with mortality and hospitalization in patients with heart failure . DESIGN , SETTING , AND PATIENTS Post hoc analysis of the r and omized , double-blinded , placebo-controlled DIG trial , conducted from August 1991 to December 1995 , with the main analysis restricted to men with a left ventricular ejection fraction of 45 % or less ( n = 3782 ) . Patients r and omly assigned to receive digoxin were divided into 3 groups based on SDC at 1 month ( 0.5 - 0.8 ng/mL , n = 572 ; 0.9 - 1.1 ng/mL , n = 322 ; and > or = 1.2 ng/mL , n = 277 ) and compared with patients r and omly assigned to receive placebo ( n = 2611 ) . MAIN OUTCOME MEASURE All-cause mortality at a mean follow-up of 37 months . RESULTS Higher SDCs were associated with increased crude all-cause mortality rates ( 0.5 - 0.8 ng/mL , 29.9 % ; 0.9 - 1.1 ng/mL , 38.8 % ; and > or = 1.2 ng/mL , 48.0 % ; P = .006 for trend ) . Patients with SDCs of 0.5 to 0.8 ng/mL had a 6.3 % ( 95 % confidence interval [ CI ] , 2.1%-10.5 % ) lower mortality rate compared with patients receiving placebo . Digoxin was not associated with a reduction in mortality among patients with SDCs of 0.9 to 1.1 ng/mL ( 2.6 % increase ; 95 % CI , - 3.0 % to 8.3 % ) , whereas patients with SDCs of 1.2 ng/mL and higher had an 11.8 % ( 95 % CI , 5.7%-18.0 % ) higher absolute mortality rate than patients receiving placebo . The association between SDC and mortality persisted after multivariable adjustment ( SDC 0.5 - 0.8 ng/mL hazard ratio [ HR ] 0.80 , 95 % CI , 0.68 - 0.94 ; SDC 0.9 - 1.1 ng/mL HR 0.89 , 95 % CI , 0.74 - 1.08 ; SDC > or = 1.2 ng/mL HR 1.16 , 95 % CI , 0.96 - 1.39 ; and HR of 1.00 [ referent ] for placebo ) . CONCLUSIONS Our findings demonstrate that higher SDCs were associated with increased mortality and suggest that the effectiveness of digoxin therapy in men with heart failure and a left ventricular ejection fraction of 45 % or less may be optimized in the SDC range of 0.5 to 0.8
The present systematic review and meta- analysis of all available data sources suggest that digoxin use is associated with an increased mortality risk , particularly among patients suffering from AF
There are conflicting data regarding the effect of digoxin use on mortality in patients with atrial fibrillation ( AF ) or with congestive heart failure ( CHF ) .
The aim of this meta- analysis was to provide detailed analysis of the currently available study reports .