Table 2.
Women’s health initiative estrogen–progestin and estrogen-alone trials, overall cohorts, intervention phasea
| Estrogen–progestin trial | Estrogen-alone trial | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CEE + MPA | Placebo | CEE | Placebo | |||||||
| Outcome | # events per 10 000 PY | # events per 10 000 PY | Differenceb per 10 000 PY | HR (95% CI) | P | # events per 10 000 PY | # events per 10 000 PY | Differenceb per 10 000 PY | HR (95% CI) | P |
| Cardiovascular disease | ||||||||||
| Coronary heart diseasec | 41 | 35 | 6 | 1.18 (0.95-1.45) | .13 | 55 | 58 | –3 | 0.94 (0.78-1.14) | .53 |
| Myocardial infarction | 35 | 29 | 6 | 1.24 (0.98-1.56) | .07 | 44 | 45 | –1 | 0.97 (0.79-1.21) | .97 |
| Coronary revascularizationd | 42 | 45 | –3 | 0.95 (0.78-1.16) | .64 | 68 | 67 | 1 | 1.00 (0.83-1.19) | .96 |
| Stroke | 33 | 24 | 9 | 1.37 (1.07-1.76) | .01 | 45 | 34 | 11 | 1.35 (1.07-1.70) | .01 |
| Pulmonary embolism | 18 | 9 | 9 | 1.98 (1.36-2.87) | <.001 | 14 | 10 | 4 | 1.35 (0.89-2.05) | .15 |
| Deep vein thrombosis | 25 | 14 | 12 | 1.87 (1.37-2.54) | <.001 | 23 | 15 | 7 | 1.48 (1.06-2.07) | .02 |
| Cardiovascular mortality | 17 | 15 | 2 | 1.08 (0.78-1.48) | .65 | 29 | 28 | 1 | 1.01 (0.78-1.31) | .95 |
| All cardiovascular eventse | 170 | 152 | 19 | 1.13 (1.02-1.25) | .02 | 251 | 224 | 27 | 1.11 (1.01-1.22) | .03 |
| Other related outcomes | ||||||||||
| Diabetes | 72 | 88 | –16 | 0.81 (0.70-0.94) | .005 | 134 | 155 | –21 | 0.86 (0.76-0.98) | .02 |
| All-cause mortality | 52 | 53 | –1 | 0.97 (0.81-1.16) | .76 | 80 | 77 | 3 | 1.03 (0.88-1.21) | .68 |
| Global indexf | 189 | 168 | 20 | 1.12 (1.02-1.24) | .02 | 208 | 204 | 4 | 1.03 (0.93-1.13) | .63 |
Adapted from data in Manson JE, et al. JAMA 2013; 310:1353–68; Manson JE, et al. JAMA 2017; 318:927–938.
Abbreviations: CEE, conjugated equine estrogens; CI, confidence interval; CVD, cardiovascular disease; HR, hazard ratio; MPA, medroxyprogesterone acetate; NA, not applicable (due to hysterectomy); PY, person-years.
a Median length of randomized treatment was 5.6 years for estrogen–progestin and 7.2 years for estrogen alone.
b Difference = # events per 10 000 women per year in the hormone therapy group – # events per 10 000 women per year in the placebo group. Numbers may not add precisely due to rounding error.
c Coronary heart disease is defined as nonfatal myocardial infarction or coronary death.
d Coronary revascularization is defined as coronary artery bypass grafting or percutaneous coronary intervention.
e “All cardiovascular events” is a composite outcome of myocardial infarction, stroke, coronary revascularization, angina, heart failure, carotid artery disease, peripheral vascular disease, venous thromboembolism (pulmonary embolism, deep vein thrombosis), and cardiovascular mortality.
f Global index is a composite outcome of coronary heart disease, stroke, pulmonary embolism, breast cancer, colorectal cancer, endometrial cancer (in the estrogen–progestin trial), hip fracture, and all-cause mortality.