Table 2.
Absolute Risk (AR), AR Reduction (ARR), Crude and Adjusted Odds Ratios (OR) with Bonferroni adjusted confidence interval, and p values for All-Cause Mortality in Women with Heart Failure Receiving Digoxin by Serum Digoxin Concentration (SDC) Versus Placebo (Reference), Data for All Women, and Stratified by Ejection Fraction (EF) 35%
| N (%) | AR | ARR | Crude OR (97.5% CI) | P value | Adjusted* OR (97.5% CI)** | P value | ||
|---|---|---|---|---|---|---|---|---|
| All Women (N=1,366) | Placebo | 955 (69.9%) | 26.9% | Reference | 1 | Reference | 1 | Reference |
| SDC 0.5-1.1 ng/ml | 282 (20.6%) | 26.6% | 0.3% | 0.98 (0.70 – 1.39) | 0.916 | 1.05 (0.73 – 1.51) | 0.762 | |
| SDC ≥1.2 ng/ml | 129 (9.4%) | 40.3% | -13.4% | 1.83 (1.19 – 2.83) | 0.002 | 1.80 (1.14 – 2.86) | 0.004 | |
| Women with EF <35% (N=677) | Placebo | 463 (68.4%) | 32.6% | Reference | 1 | Reference | 1 | Reference |
| SDC 0.5-1.1 ng/ml | 148 (21.9%) | 27.0% | 5.6% | 0.77 (0.48 – 1.23) | 0.203 | 0.77 (0.47 – 1.26) | 0.233 | |
| SDC ≥1.2 ng/ml | 66 (9.7%) | 47.0% | -14.4% | 1.83 (1.01 – 3.32) | 0.023 | 1.77 (0.94 – 3.36) | 0.044 | |
| Women with EF ≥35% (N=689) | Placebo | 492 (71.4%) | 21.5% | Reference | 1 | Reference | 1 | Reference |
| SDC 0.5-1.1 ng/ml | 134 (19.4%) | 26.1% | -4.6 | 1.29 (0.78 – 2.13) | 0.262 | 1.58 (0.92 – 2.72) | 0.058 | |
| SDC ≥1.2 ng/ml | 63 (9.1%) | 33.3% | -11.8 | 1.82 (0.95 – 3.48) | 0.038 | 1.87 (0.93 – 3.76) | 0.045 |
Adjusted for age, sex, race, body mass index, duration of heart failure in months, etiology of heart failure, prior myocardial infarction, current angina, hypertension, diabetes, NYHA functional class, use of angiotensin-converting enzyme inhibitors, diuretics, and combination of hydralazine and nitrates, current dyspnea at rest and dyspnea on exertion, heart rate, systolic and diastolic blood pressure, current jugular venous distension, third heart sound, pulmonary râles, and lower extremity edema, estimated glomerular filtration rate, pulmonary congestion by chest x-ray, and cardiothoracic ratio >0.5. Addition adjustment for left ventricular ejection fraction less that 35% for all women.
Alpha=0.025 (0.05/2) was used to construct individual confidence intervals to achieve an overall 95% confidence intervals using Bonferroni adjustment