Table 1.
Trial of CEE Alone | Trial of CEE + MPA | |||||||
---|---|---|---|---|---|---|---|---|
Characteristic | CEE (n = 1,639) | Placebo (n = 1,674) | CEE + MPA (n = 2,837) | Placebo (n = 2,683) | ||||
No. | % | No. | % | No. | % | No. | % | |
Age at screening, yearsa | 54.9 (2.8) | 54.9 (2.9) | 55.2 (2.6) | 55.3 (2.6) | ||||
Age group at screening, years | ||||||||
50–54 | 687 | 41.9 | 709 | 42.4 | 1,041 | 36.7 | 983 | 36.6 |
55–59 | 952 | 58.1 | 965 | 57.6 | 1796 | 63.3 | 1700 | 63.4 |
Race/ethnicity | ||||||||
White | 1,085 | 66.2 | 1,098 | 65.6 | 2,192 | 77.3 | 2061 | 76.8 |
Black | 317 | 19.3 | 349 | 20.8 | 255 | 9.0 | 279 | 10.4 |
Hispanic | 164 | 10.0 | 172 | 10.3 | 265 | 9.3 | 226 | 8.4 |
American Indian | 18 | 1.1 | 10 | 0.6 | 11 | 0.4 | 16 | 0.6 |
Asian/Pacific Islander | 29 | 1.8 | 23 | 1.4 | 68 | 2.4 | 63 | 2.3 |
Unknown | 26 | 1.6 | 22 | 1.3 | 46 | 1.6 | 38 | 1.4 |
Beyond high school/GED | 1,130 | 69.8 | 1,182 | 71.7 | 2,184 | 77.6 | 2015 | 75.9 |
Family income at least $50,000 | 509 | 32.6 | 516 | 32.7 | 1,099 | 40.8 | 1,045 | 40.9 |
No. of years since menopause | ||||||||
<5 | 281 | 20.4 | 288 | 20.3 | 1,196 | 47.5 | 1,137 | 46.2 |
5–9 | 331 | 24.0 | 338 | 23.9 | 871 | 34.6 | 886 | 36.0 |
≥10 | 767 | 55.6 | 790 | 55.8 | 452 | 17.9 | 436 | 17.7 |
HT use status | ||||||||
Never used | 841 | 51.3 | 831 | 49.6 | 1983 | 69.9 | 1951 | 72.7 |
Past user | 513 | 31.3 | 531 | 31.7 | 553 | 19.5 | 482 | 18.0 |
Current userb | 285 | 17.4 | 312 | 18.6 | 301 | 10.6 | 250 | 9.3 |
Baseline vasomotor symptoms | ||||||||
None | 609 | 37.5 | 636 | 38.4 | 1,195 | 42.6 | 1,100 | 41.4 |
Mild | 560 | 34.4 | 573 | 34.6 | 972 | 34.6 | 975 | 36.7 |
Moderate/severe | 457 | 28.1 | 448 | 27.0 | 641 | 22.8 | 584 | 22.0 |
BMIc,d | 30.2 (8.6) | 30.1 (8.7) | 27.7 (7.9) | 27.8 (8.2) | ||||
BMIc | ||||||||
<25 | 290 | 17.8 | 269 | 16.1 | 840 | 29.8 | 806 | 30.2 |
25–29 | 511 | 31.4 | 544 | 32.7 | 962 | 34.1 | 862 | 32.3 |
≥30 | 827 | 50.8 | 853 | 51.2 | 1,017 | 36.1 | 999 | 37.5 |
Systolic BP, mm Hga | 124.8 (15.8) | 125.1 (16.2) | 121.7 (15.7) | 122.3 (16.1) | ||||
Diastolic BP, mm Hga | 78.0 (9.0) | 77.9 (9.1) | 76.4 (9.0) | 76.6 (8.9) | ||||
Smoking status | ||||||||
Never | 789 | 48.6 | 769 | 46.2 | 1,300 | 46.2 | 1,254 | 47.3 |
Past | 597 | 36.8 | 646 | 38.8 | 1,104 | 39.2 | 978 | 36.9 |
Current | 237 | 14.6 | 249 | 15.0 | 411 | 14.6 | 420 | 15.8 |
Bilateral oophorectomy | 530 | 34.1 | 599 | 37.8 | 6 | 0.2 | 5 | 0.2 |
Treated diabetes (pills or shots) | 114 | 7.0 | 107 | 6.4 | 103 | 3.6 | 109 | 4.1 |
Hypertensive (self-report or high BP) | 625 | 42.1 | 657 | 43.2 | 797 | 31.5 | 772 | 31.0 |
High cholesterol | 134 | 8.2 | 158 | 9.4 | 163 | 5.7 | 167 | 6.2 |
Statin use | 54 | 3.3 | 66 | 3.9 | 59 | 2.1 | 66 | 2.5 |
Aspirin use of ≥80 mg for ≥30 days | 204 | 12.4 | 197 | 11.8 | 346 | 12.2 | 350 | 13.0 |
MI ever | 22 | 1.3 | 21 | 1.3 | 18 | 0.6 | 16 | 0.6 |
History of angina | 75 | 4.6 | 64 | 3.8 | 59 | 2.1 | 54 | 2.0 |
History of CABG/PCI | 17 | 1.0 | 15 | 0.9 | 6 | 0.2 | 11 | 0.4 |
Stroke ever | 9 | 0.5 | 17 | 1.0 | 12 | 0.4 | 10 | 0.4 |
History of DVT/PE | 33 | 2.0 | 28 | 1.7 | 24 | 0.8 | 17 | 0.6 |
History of fracture, age ≥55 | 40 | 5.1 | 42 | 5.3 | 69 | 4.8 | 62 | 4.3 |
Family history of female relative w/breast cancer | 285 | 18.5 | 261 | 16.4 | 403 | 14.9 | 371 | 14.6 |
Abbreviations: BMI, body mass index; BP, blood pressure; CABG, coronary artery bypass graft; CEE, conjugated equine estrogens; DVT, deep vein thrombosis; GED, General Educational Development certificate; HT, menopausal hormone therapy; MI, myocardial infarction; MPA, medroxyprogesterone acetate; PCI, percutaneous coronary intervention; PE, pulmonary embolism.
a Values are expressed as mean (standard deviation).
b Required a 3-month washout prior to randomization.
c Weight (kg)/height (m)2.
d Values are expressed as median (interquartile range).