Digoxin-mortality: randomized vs. observational comparison in the DIG trial.

ABSTRACT:

Aims

The Digitalis Investigation Group (DIG) trial, the only large randomized trial of digoxin in heart failure, reported a neutral effect on mortality and a significant reduction in heart failure hospitalizations. Recent observational studies reported increased mortality with digoxin treatment. We present further analyses of the DIG trial displaying the inability to control bias in observational treatment comparisons despite extensive statistical adjustments.

Methods and results

Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment. We contrast the main randomization-based result of the DIG trial with the observational non-randomized comparison of patients

SUBMITTER: Aguirre Davila L 

PROVIDER: S-EPMC6801940 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature