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. 2014 Apr 28;2014(4):CD002901. doi: 10.1002/14651858.CD002901.pub3

DIG study 1997.

Methods Three‐ to five‐yr (mean follow‐up 37 mo) multicenter parallel trial; primary endpoint—mortality; secondary endpoint—hospitalization for HF
Participants 6800 pts with EF ≤ 0.45 in main trial; mean age 63; 88% male; 54% Class II, 31% Class III; 82% on diuretics, 94% on ACEI; EF 0.29 & 0.28 (dig & pla); median duration of HF 17 & 16 mo (dig & pla); prior dig Rx in 44%; dx—71% ischemic, 15% idiopathic. Note: ancillary trial carried out in 988 additional pts with EF > 0.45
Interventions dig dosage at investigators' discretion; median baseline dosage in main trial of 0.25 mg/d
Outcomes main trial mortality, dig versus pla: overall 34.8% & 35.1% (P value 0.80), from "worsening heart failure" 11.6% & 13.2% (P value 0.06), from "other cardiac" 15.0% & 13.0% (P value 0.04); main trial hospitalization, dig versus pla: 26.8% & 34.7% (P < 0.001); ancillary trial mortality 23.4% in both groups
Notes blind allocation—yes
 blinded to outcomes—?
 baselines comparable—yes
 main trial loss to follow‐up—1.4%
 dig titrated to level—no
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A—Adequate