Table 1.
Baseline Characteristics of Participants in the Women’s Health Initiative Trials of Postmenopausal Hormone Therapy
| Characteristic | CEE+MPA Trial | CEE Alone Trial | ||||||
|---|---|---|---|---|---|---|---|---|
| Active (n=8506) | Placebo (n=8102) | Active (n=5310) | Placebo (n=5429) | |||||
| N | % | N | % | N | % | N | % | |
| Age at screening, y, mean ( SD) | 63.2 | (7.1) | 63.3 | (7.1) | 63.6 | (7.3) | 63.6 | (7.3) |
| Age group at screening, y, % | ||||||||
| 50–59 | 2837 | 33.4 | 2683 | 33.1 | 1639 | 30.9 | 1674 | 30.8 |
| 60–69 | 3854 | 45.3 | 3655 | 45.1 | 2386 | 44.9 | 2465 | 45.4 |
| 70–79 | 1815 | 21.3 | 1764 | 21.8 | 1285 | 24.2 | 1290 | 23.8 |
| Race/ethnicity, % | ||||||||
| White | 7141 | 84.0 | 6805 | 84.0 | 4009 | 75.5 | 4075 | 75.1 |
| Black | 548 | 6.4 | 574 | 7.1 | 781 | 14.7 | 835 | 15.4 |
| Hispanic | 471 | 5.5 | 415 | 5.1 | 319 | 6.0 | 332 | 6.1 |
| American Indian | 25 | 0.3 | 30 | 0.4 | 41 | 0.8 | 34 | 0.6 |
| Asian/Pacific Islander | 194 | 2.3 | 169 | 2.1 | 86 | 1.6 | 78 | 1.4 |
| Unknown | 127 | 1.5 | 109 | 1.3 | 74 | 1.4 | 75 | 1.4 |
| Years since menopause, y, % | ||||||||
| < 10 | 2780 | 36.2 | 2711 | 36.1 | 827 | 18.4 | 817 | 17.6 |
| 10 – <20 | 3049 | 39.7 | 2992 | 39.9 | 1438 | 32.0 | 1500 | 32.4 |
| ≥20 | 1850 | 24.1 | 1805 | 24.0 | 2230 | 49.6 | 2319 | 50.0 |
| Hormone use, % | ||||||||
| Never | 6277 | 73.8 | 6022 | 74.4 | 2769 | 52.2 | 2769 | 51.0 |
| Past | 1671 | 19.7 | 1587 | 19.6 | 1871 | 35.2 | 1947 | 35.9 |
| Current‡ | 554 | 6.5 | 490 | 6.1 | 669 | 12.6 | 709 | 13.1 |
| Vasomotor symptoms. % | ||||||||
| None | 5162 | 61.3 | 4928 | 61.5 | 2962 | 56.4 | 3004 | 56.0 |
| Mild | 2190 | 26.0 | 2115 | 26.4 | 1377 | 26.2 | 1441 | 26.9 |
| Moderate or severe | 1072 | 12.7 | 974 | 12.1 | 913 | 17.4 | 917 | 17.1 |
| Body mass index, kg/m2, median (IQR) | 27.5 (24.2–31.7) | 27.5 (24.3–31.7) | 29.2 (25.7–33.7) | 29.2 (25.7–33.5) | ||||
| Body mass index, kg/m2, % | ||||||||
| <25 | 2579 | 30.4 | 2479 | 30.8 | 1110 | 21.0 | 1096 | 20.3 |
| 25–29 | 2992 | 35.3 | 2835 | 35.2 | 1798 | 34.0 | 1915 | 35.5 |
| ≥30 | 2899 | 34.2 | 2737 | 34.0 | 2375 | 45.0 | 2385 | 44.2 |
| Systolic BP, mm Hg, mean (SD) | 127.6 | (17.6) | 127.8 | (17.5) | 130.4 | (17.5) | 130.2 | (17.6) |
| Diastolic BP, mm Hg, mean (SD) | 75.6 | (9.1) | 75.8 | (9.1) | 76.5 | (9.2) | 76.5 | (9.4) |
| Smoking, % | ||||||||
| Never | 4178 | 49.6 | 3999 | 50.0 | 2723 | 51.9 | 2705 | 50.4 |
| Past | 3362 | 39.9 | 3157 | 39.5 | 1986 | 37.8 | 2090 | 38.9 |
| Current | 880 | 10.5 | 838 | 10.5 | 542 | 10.3 | 571 | 10.6 |
| Never pregnant/no term pregnancy, % | 860 | 11.2 | 833 | 11.5 | 491 | 10.4 | 463 | 9.5 |
| Age at first birth (among those ever pregnant), y, % | ||||||||
| <20 | 1124 | 16.4 | 1117 | 17.3 | 1193 | 28.1 | 1234 | 28.0 |
| 20–29 | 4996 | 73.0 | 4698 | 73.0 | 2846 | 67.0 | 2914 | 66.1 |
| ≥30 | 727 | 10.6 | 624 | 9.7 | 210 | 4.9 | 260 | 5.9 |
| Age at hysterectomy, y, % | ||||||||
| <40 | 2100 | 39.8 | 2148 | 39.8 | ||||
| 40–49 | 2280 | 43.2 | 2275 | 42.2 | ||||
| 50–54 | 501 | 9.5 | 566 | 10.5 | ||||
| ≥55 | 401 | 7.6 | 404 | 7.5 | ||||
| Bilateral oophorectomy, % | 29 | 0.3 | 24 | 0.3 | 1938 | 39.5 | 2111 | 42.0 |
| Medical treatment, % | ||||||||
| Treated for diabetes | 374 | 4.4 | 360 | 4.4 | 410 | 7.7 | 412 | 7.6 |
| Treated for hypertension or BP ≥140/90 | 3377 | 43.2 | 3283 | 42.7 | 2651 | 53.3 | 2647 | 52.6 |
| Elevated cholesterol levels requiring medication | 1018 | 12.0 | 1027 | 12.7 | 763 | 14.4 | 829 | 15.3 |
| Statin use at baseline | 580 | 6.8 | 535 | 6.6 | 397 | 7.5 | 430 | 7.9 |
| Aspirin use (≥80 mg/d) at baseline | 1652 | 19.4 | 1654 | 20.4 | 1050 | 19.8 | 1081 | 19.9 |
| Medical history, % | ||||||||
| Myocardial infarction | 139 | 1.6 | 157 | 1.9 | 165 | 3.1 | 173 | 3.2 |
| Angina | 318 | 3.8 | 331 | 4.1 | 402 | 7.6 | 388 | 7.2 |
| CABG/PCI | 95 | 1.1 | 120 | 1.5 | 120 | 2.3 | 114 | 2.1 |
| Stroke | 61 | 0.7 | 77 | 1.0 | 76 | 1.4 | 92 | 1.7 |
| Deep vein thrombosis or pulmonary embolism | 79 | 0.9 | 62 | 0.8 | 87 | 1.6 | 84 | 1.5 |
| Family history of breast cancer | 1286 | 16.0 | 1175 | 15.3 | 892 | 17.9 | 870 | 17.1 |
| Fracture at age ≥55 | 1030 | 16.6 | 1027 | 16.7 | 676 | 17.3 | 643 | 16.4 |
| > High school/GED, % | 6272 | 74.1 | 5899 | 73.3 | 3488 | 66.3 | 3678 | 68.3 |
| Family income ≥ $50,000, % | 2447 | 30.4 | 2401 | 31.4 | 1148 | 22.9 | 1167 | 22.9 |
‡
Required a 3-month washout prior to randomization
CABG/PCI=coronary artery bypass graft/percutaneous coronary intervention