TABLE 3.
Characteristics of participants at the time of KEEPS continuation
| All (n = 299) | oCEE (n = 90) | tE2 (n = 96) | Placebo (n = 113) | Overall P value | |
|---|---|---|---|---|---|
| Age (y) | 67 (2) | 67 (3) | 67 (2) | 67 (2) | 0.86 |
| Education (y) | 16 (3) | 16 (2) | 16 (2) | 16 (3) | 0.57 |
| Time from KEEPS baseline to continuation (y) | 14 (1) | 14 (1) | 14 (1) | 14 (1) | 0.44 |
| BMI (kg/m2) | 26.8 (5.0) | 26.8 (5.1) | 26.5 (5.0) | 27.0 (5.0) | 0.78 |
| Waist/hip ratio | 0.9 (0.1) | 0.9 (0.1) | 0.9 (0.1) | 0.8 (0.1) | 0.78 |
| Diabetes medication use, n (%) | 11 (4) | 1 (1) | 1 (1) | 9 (8) | 0.01 a |
| Antihypertensive use, n (%) | 88 (29) | 28 (31) | 23 (24) | 37 (33) | 0.35 |
| Lipid modifying medications, n (%) | 60 (20) | 22 (24) | 12 (12) | 26 (23) | 0.07 |
| Diabetes, n (%) | 6 (2) | 0 | 0 | 6 (6) | 0.007 |
| Smoker, n (%) | 15 (5) | 1 (1) | 5 (5) | 9 (8) | 0.07 |
| Systolic BP (mm Hg) | 127 (17) | 126 (17) | 128 (17) | 128 (18) | 0.74 |
| Diastolic BP (mm Hg) | 76 (9) | 76 (10) | 77 (9) | 76 (9) | 0.97 |
| Total cholesterol (mg/dL) | 207 (40) | 205 (38) | 209 (39) | 207 (42) | 0.83 |
| HDL-C (mg/dL) | 68 (18) | 67 (17) | 68 (18) | 69 (17) | 0.69 |
| LDL-C (mg/dL) | 118 (35) | 117 (34) | 119 (35) | 118 (36) | 0.89 |
| Triglycerides (mg/dL) | 107 (50) | 111 (54) | 111 (46) | 102 (50) | 0.34 |
| Glucose (mg/dL) | 94 (11) | 94 (10) | 93 (10) | 94 (12) | 0.88 |
| Insulin (uIU/mL) | 4.6 (4.1) | 4.9 (5.3) | 4.5 (3.8) | 4.4 (3.1) | 0.71 |
| HOMA-IR | 1.0 (1.2) | 1.2 (1.9) | 0.9 (0.7) | 1.0 (0.8) | 0.31b |
| Fracture after KEEPS, n (%)c | 49 (16) | 11 (12) | 18 (19) | 20 (18) | 0.42 |
| Spine or hip fracture after KEEPS, n (%) | 0 | 0 | 0 | 0 | |
| Heart attack or angina, n (%) | 0 | 0 | 0 | 0 | |
| Congestive heart failure, n (%) | 1 (0.3) | 1 (1) | 0 | 0 | |
| Coronary artery disease, n (%) | 3 (1) | 1 (1) | 1 (1) | 1 (1) | >0.99 |
| Stroke, n (%) | 5 (2) | 0 | 2 (2) | 3 (3) | 0.39 |
| Cancer since start of KEEPS, n (%)d | 38 (13) | 10 (11) | 17 (18) | 11 (10) | 0.20 |
| Breast | 11 (4) | 3 (3) | 5 (5) | 3 (3) | 0.69 |
| Ovary | 2 (0.7) | 0 | 1 (1) | 1 (1) | >0.99 |
| Uterus | 4 (1) | 2 (2) | 0 | 2 (2) | 0.47 |
| Other | 29 (10) | 8 (9) | 13 (14) | 8 (7) | 0.30 |
| Age cancer diagnosed | 57 (10) | 57 (9) | 59 (8) | 54 (13) | 0.30 |
| Liver disease, n (%) | 6 (2) | 2 (2) | 3 (3) | 1 (1) | 0.52 |
| Kidney disease, n (%) | 9 (3) | 2 (2) | 1 (1) | 6 (5) | 0.22 |
| Hormone therapy after KEEPS, n (%)e | 56 (19) | 23 (26) | 14 (15) | 19 (17) | 0.14 |
| Vaginal estradiol | 22 (7) | 7 (8) | 5 (5) | 10 (9) | 0.62 |
| Transdermal estradiol | 13 (4) | 5 (6) | 6 (6) | 2 (2) | 0.22 |
| Oral estradiol | 10 (3) | 5 (6) | 1 (1) | 4 (4) | 0.21 |
| Compounded bio-identical estrogen | 7 (2) | 2 (2) | 2 (2) | 3 (3) | >0.99 |
| oCEE | 4 (1) | 4 (4) | 0 | 0 | 0.008 |
Characteristics represent data collected between years 2017 and 2022 when women were recontacted for the KEEPS continuation study. Data shown are mean (SD) or n (%). Groupwise P values comparing treatment to placebo are from Fisher exact test or analysis of variance followed by Tukey pairwise tests, as appropriate.
BMI, body mass index; BP, blood pressure; HDL-C, high-density lipoprotein cholesterol; KEEPS, Kronos Early Estrogen Prevention Study; LDL-C, low-density lipoprotein cholesterol; HOMA-IR, homeostasis model assessment of insulin resistance; oCEE, oral conjugated equine estrogen.
The statistically significant findings are written in bold format.
aPairwise comparison P values between oCEE and placebo, 0.045; tE2 and placebo, 0.02.
bP value is from log-transformed HOMA-IR.
cEleven participants have fractures in multiple places. P value is from “Yes/No” fracture after KEEPS.
dFive participants have cancer in multiple places. P value is from “Yes/No” cancer since KEEPs.
eP value is from “Yes/No” taking hormone therapy after KEEPS.