| Trial | control | p<0.05 | harm | NS |
|---|
| Fleg, 1982 | vs placebo | | | clinical deterioration NaN [NaN; NaN] |
| Lee, 1982 | vs placebo | | | clinical deterioration 0.67 [0.28; 1.59] |
| Taggart, 1983 | vs placebo | | | clinical deterioration 0.53 [0.11; 2.56] |
| Captopril-Digoxin Multicenter Research Group (CDMRG), 1988 | vs placebo | hospitalization for worsening heart failure 0.28 [0.08; 0.99] clinical deterioration 0.28 [0.10; 0.81] | | all cause death 1.22 [0.42; 3.49] |
| German and Austrian Xamoterol Study, 1988 | vs placebo | | | all cause death 0.00 [0.00; NaN] clinical deterioration 0.70 [0.20; 2.41] |
| Guyatt, 1988 | vs placebo | | | clinical deterioration 0.00 [0.00; NaN] |
| DiBianco, 1989 | vs placebo | clinical deterioration 0.31 [0.16; 0.61] | | all cause death 0.79 [0.17; 3.75] |
| Pugh, 1989 | vs placebo | | | clinical deterioration 0.45 [0.17; 1.20] |
| Blackwood, 1990 | vs placebo | | | all cause death 0.00 [0.00; NaN] clinical deterioration 0.00 [0.00; NaN] |
| Radiance, 1993 | vs placebo | hospitalisation for heart failure 0.18 [0.04; 0.79] clinical deterioration 0.19 [0.07; 0.53] | | hospitalization for worsening heart failure 0.24 [0.05; 1.09] all cause death 3.28 [0.35; 30.96] |
| Proved, 1993 | vs placebo | | | hospitalization for worsening heart failure 0.55 [0.15; 2.05] all cause death 0.55 [0.05; 5.82] clinical deterioration 0.61 [0.22; 1.67] |
| DIMT, 1993 | vs placebo | | | all cause death 0.64 [0.11; 3.69] clinical deterioration 0.00 [0.00; NaN] |
| Digitalis Investigation Group (DIG), 1997 | vs placebo | death due to worsening heart failure 0.88 [0.77; 1.00] hospitalization for worsening heart failure 0.77 [0.72; 0.83] hospitalisation for heart failure 0.77 [0.72; 0.83] hospitalisation of cardiovascular cause 0.92 [0.88; 0.96] | | non cardiovascular death 0.87 [0.71; 1.07] all cause death 0.99 [0.93; 1.06] Cardiovascular death 0.99 [0.93; 1.06] |
| Trial | Treatments | Patients | Method |
|---|
| Fleg, 1982 | digoxin titrated to serum level of 1.0 to 2.0 ng/mL (n=30) vs. placebo (n=30) | patients with chronic clinically compensated congestive heart failure and normal sinus rhythm | dobl eblind cross-over Sample size: 30/30 Primary endpoint: FU duration: 3 months |
| Lee, 1982 | digoxin titrated to mean serum level of 1.15 ng/mL, mean dig dosage .435 mg/day (n=25) vs. placebo (n=25) | outpatients without atrial fibrillation | double blind cross-over Sample size: 25/25 Primary endpoint: FU duration: 53 days |
| Taggart, 1983 | digoxin (mean plasma dig level 1.2 ng/mL) (n=22) vs. placebo (digoxin withdrawal) (n=22) | patients with sinus rhythm who had a previous history of frank heart failure | double blind cross-over Sample size: 22/22 Primary endpoint: FU duration: 3 months |
| Captopril-Digoxin Multicenter Research Group (CDMRG), 1988 | digoxin of .125-.375 mg/day titrated to serum levels of .7-2.5 ng/mL (n=-9) vs. placebo (digoxin withdrawal) (n=-9) | patients with mild to moderate heart failure. | double blind parallel group Sample size: -9/-9 Primary endpoint: FU duration: 6 months |
| German and Austrian Xamoterol Study, 1988 | digoxin .125 mg twice dayly (mean plasma dig level .87 ng/mL) (n=-9) vs. placebo (n=-9) | patients aged 29-80 with mild to moderate heart failure | double blind parallel group Sample size: -9/-9 Primary endpoint: FU duration: 3 months |
| Guyatt, 1988 | digoxin titrated to serum level of 1.54– 2.56 nmol/L (1.2–2.0 ng/mL), mean dig dosage 0.391 mg/day (n=20) vs. placebo (n=20) | congestive heart failure patients in sinus rhythm | double blind cross-over Sample size: 20/20 Primary endpoint: FU duration: 7 weeks |
| DiBianco, 1989 | digoxin .125-.5 mg/ day (n=-9) vs. placebo (n=-9) | patients in sinus rhythm with moderately severe heart failure | double blind parallel group Sample size: -9/-9 Primary endpoint: FU duration: 3 months |
| Pugh, 1989 | digoxin (patient’s “usual dose” ) (n=44) vs. placebo (digoxin withdrawal) (n=44) | patients with stable heart failure in sinus rhythm and plasma digoxin concentrations over 0.8 ng/ml | double blind cross-over Sample size: 44/44 Primary endpoint: FU duration: 2 months |
| Blackwood, 1990 | digoxin .25 mg/day (n=61) vs. placebo (n=0) | patients with heart failure | double blind parallel group Sample size: 61/0 Primary endpoint: FU duration: 3 months |
| Radiance, 1993 | digoxin titrated to serum level of 1.2 ng/mL (mean dig dosage .38 mg/day) (n=85) vs. placebo (digoxin withdrawal) (n=93) | patients with New York Heart Association class II or III heart failure and left ventricular ejection fractions of 35 percent or less in normal sinus rhythm who were clinically stable while receiving digoxin, diuretics, and an angiotensin-converting-enzyme inhibitor (captopril or enalapril) | double blind Sample size: 85/93 Primary endpoint: FU duration: 3 months |
| Proved, 1993 | digoxin titrated to serum level of 1.2 ng/mL (median dig dosage .375 mg/day) (n=42) vs. placebo (digoxin withdrawal) (n=46) | patients with chronic, stable mild to moderate heart failure | double blind withdrawal trial Sample size: 42/46 Primary endpoint: FU duration: 3 months |
| DIMT, 1993 | digoxin .25 mg/day (mean plasma level .94 ng/mL) (n=55) vs. placebo (n=53) | patients with mild to moderate chronic heart failure | double blind parallel group Sample size: 55/53 Primary endpoint: FU duration: 6 months |
| Digitalis Investigation Group (DIG), 1997 | digoxin dosage at investigators’ discretion (median baseline dosage in main trial of .25 mg/day) (n=3397) vs. placebo (n=3403) median dose of digoxin, 0.25 mg per day | patients with left ventricular ejection fractions of 0.45 or less and normal sinus rhythm The left ventricular
ejection fraction was assessed by radionuclide left ventriculography,
left ventricular contrast angiography, or two-dimensional
echocardiography. | Double blind Parallel groups Sample size: 3397/3403 Primary endpoint: mortality FU duration: 37 mo (mean) |
