The Women’s Health Initiative Hormone Trials The Estrogen Only (women with a hysterectomy at baseline) and the Estrogen + Progestin (women with a uterus) Cohorts Marcia L. Stefanick, Ph.D. Professor of Medicine and, Professor of Obstetrics and Gynecology Stanford Prevention Research Center Stanford University WHI PrincipaI Investigator, Stanford Chair, WHI Steering Committee
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The Women’s Health Initiative Hormone Trials The Estrogen Only (women with a hysterectomy at baseline) and the Estrogen + Progestin (women with a uterus)
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The Women’s Health Initiative Hormone Trials The Estrogen Only (women with a hysterectomy at baseline)
and the Estrogen + Progestin (women with a uterus) Cohorts
WHI HT: Baseline Age DistributionWHI HT: Baseline Age DistributionMeanMean± SD± SD: : HystX-E only = 63.6HystX-E only = 63.6±±7.37.3; ; Uterus-E+P = 63.3Uterus-E+P = 63.3±±7.17.1
60-69E=45%; E+P=45%
70-79 E=24%; E+P=22%
50-59E=31%; E+P=33%
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
WHI HT: Minority Distribution (% of Cohort)WHI HT: Minority Distribution (% of Cohort) EE-Only: 2511-Only: 2511/10,739/10,739 (23.3%)(23.3%) E+P: N = 2531 E+P: N = 2531/16,608/16,608 (14.6%)(14.6%)
15.0
6.1
2.20.7
1.4
6.85.3
1.50.3
1.4
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
18.0
20.0
Blacks Hispanic Asian/PI Native Am Other
Percent
Hysterectomy- E only (75.3% White) Uterus - E+P (84.0 % White )
Blacks (N)E: 1617 E+P: 1124
Hispanic (N)E: 655 E+P: 888
Asian/PI (N) E: 164 E+P: 363
Nat. Amer. E: 75 E+P: 56
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
WHI Hormone Trials: Minority Distribution by AgeWHI Hormone Trials: Minority Distribution by Age 50-59: E (32.7%) 60-69: E (22.0%) 70-79: E (13.9%)50-59: E (32.7%) 60-69: E (22.0%) 70-79: E (13.9%) E+P (21.5%) E+P (12.5%) E+P E+P (21.5%) E+P (12.5%) E+P ( 8.6%)( 8.6%)
66
20
1014
510
2
77
8690
8577
2446910
0102030405060708090
100
W B H W B H W B H
Percent
Hysterectomy- E only (75.3% White) Uterus - E+P (84.0 % White )
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
Mean BMI: E only = 30.1 ± 6.2; E+P = 28.5 ± 5.9 % Overweight+Obese: 79.3 % 69.4%
BMI (kg/m2 )
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
WHI Hormone Trials: BMI (kg/mWHI Hormone Trials: BMI (kg/m22) by Age) by Age 50-59: E (31.2) 60-69: E (30.2) 70-79: E (28.6)50-59: E (31.2) 60-69: E (30.2) 70-79: E (28.6) E+P (28.9) E+P (28.6) E+P (27.5) E+P (28.9) E+P (28.6) E+P (27.5)
17
32
51
34
46
3934
30 28
35
26
20
28
3735363733
0
10
20
30
40
50
60
Normal Overwt Obese Normal Overwt Obese Normal Overwt Obese
Percent
Hysterectomy- E only Uterus - E+P
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Coronary Heart Disease by Age: Annualized Rates, HRs
CEE only Trial CEE+MPA Trial . Total: HR 0.91 (95% CI = 0.75-1.12) HR 1.24 (95% CI = 1.00-1.54)
HR (decade): 0.56 0.92 1.04 1.27 1.05 1.44
Baseline Age (decade)
16
49
14
32
61
16
30
10
23
71
4857
01020304050607080
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Stroke by Age: Annualized Rates, HRs
CEE only Trial CEE+MPA Trial .
Total: HR 1.39 (95% CI = 1.10-1.77) HR 1.31 (95% CI = 1.02-1.68)HR (decade): 1.08 1.65 1.25 1.46 1.35 1.26
Baseline Age (decade)
2126
32 31
44
2936
54
4136
2634
0
10
20
30
40
50
60
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Invasive Breast Cancer: Annualized Rates, HRs
CEE only Trial CEE+MPA Trial . Total: HR 0.77 (95% CI = 0.59-1.01) HR 1.24 (95% CI = 1.01-1.54)
HR (decade): 0.72 0.72 0.94 1.20 1.22 1.34
Baseline Age (decade)
4 4
32
19
33
1
113
11
4852
0
10
20
30
40
50
60
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Hip Fracture by Age: Annualized Rates, Hazard Ratios
CEE only Trial CEE+MPA Trial . Total: HR 0.61 (95% CI = 0.41-0.91) HR 0.67 (95% CI = 0.47-0.96)
HR (decade): 5.04 0.33 0.62 0.17 0.76 0.69
Baseline Age (decade)
7
16
32
410
1412
19
5
19
28
15
05
10152025303540
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Colorectal Cancer by Age: Annualized Rates, HRs
CEE only Trial CEE+MPA Trial . Total: HR 1.08 (95% CI = 0.75-1.55) HR 0.61 (95% CI = 0.42- 0.87)HR (decade): 0.59 0.88 2.09 0.79 0.54 0.51
Baseline Age (decade)
29
79
154
22
51
108
39
79
2947
130
103
0255075
100125150175
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Total Death by Age: Annualized Rates, HRs
CEE only Trial CEE+MPA Trial . Total: HR 1.04 (95% CI = 0.88-1.22) HR 0.98 (95% CI = 0.82-1.28)
HR (decade): 0.73 1.01 1.20 0.75 1.05 1.02
Baseline Age (decade)
89
328
92
172
303
11180
148195 197
276288
050
100150200250300350
50-59 60-69 70-79 50-59 60-69 70-79N per 10,000 per year
CEE Placebo CEE+MPA
WHI Global Index by Age: Annualized Rates, HRs
CEE only Trial CEE+MPA Trial . Total: HR 1.01 (95% CI = 0.91-1.12) HR 1.15 (95% CI =1.03-1.28)
HR (decade): 0.80 0.98 1.16 1.16 1.18 1.10
Baseline Age (decade)
11,941 Provided Consent and reported a hysterectomy
373,092 Women Initiated Screening
10,739 Randomized
Status on 02/29/04Alive & Outcomes data submitted in last 18 months (n = 4757) 89.6%Withdrew (n = 136) 2.6%Lost to follow-up (n = 126) 2.3%Deceased (n = 291) 5.5%
Status on 02/29/04Alive & Outcomes data submitted in last 18 months (n = 4839) 89.1%Withdrew (n = 185) 3.4%Lost to follow-up (n = 116) 2.1%Deceased (n = 289) 5.3%
CEE (N = 5310) Placebo (N = 5429)
WHI E-Alone Trial: Participant Retention
The Women’s Health Initiative Steering Committee: JAMA 2004; 291: 1701-1712
The Women’s Health Initiative Steering Committee: JAMA 2004; 291: 1701-1712
Risk Benefit
P=.007 P=0.01P=.06
VTE: nsDVT
P=.03
• Excess risk per 10,000 women per year on CEE– 12 more women with strokes– 6 more Deep Vein Thrombosis (DVT)– unclear: more total blood clots in lungs (PE) + legs (DVTs)
• Risk reduction per 10,000 women per year– 6 fewer hip fractures– 6 fewer clinical vertebral fractures– unclear: 7 fewer breast cancer (Tumor characteristics unknown)
• Neutral (no differences) – Coronary Heart Disease– Colorectal cancer (Tumor characteristics unknown)