the women’s health initiative hormone trials the estrogen only (women with a hysterectomy at...
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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
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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WHI Hormone Program Design
Hysterectomy
CEE (Conjugated equine estrogens) 0.625 mg/d
CEE 0.625 mg/d + medroxyprogesterone acetate (MPA) 2.5 mg/d
N= 16,608
N= 10,739YES
NO
Placebo
Placebo
*
*Initially: CEE only (N=331), CEE+MPA, or Placebo (CEE only were subsequently converted to CEE+MPA)
= Premarin®
= Prempro®
Current HT required 3-month wash-out before baseline testing.
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E-AloneCEE
10,739
WHI Hormone Sample Size, Outcomes, Follow-upWHI Hormone Sample Size, Outcomes, Follow-up
Women, aged 50-79 Women, aged 50-79 TotalTotal HT trials = 27,347 HT trials = 27,347
Hormone Trials Primary Outcome: Coronary Heart Disease Secondary Outcomes: Breast, Colon, Endometrial Cancers Hip Fracture; Other Fractures Stroke, Pulmonary Emboli WHI Memory Study (WHIMS) - for women aged ≥ 65: Dementia
Average Follow-up 5.6 years*
Average 6.8 years*
E+P CEE+MPA
16,608
*design = 8.5 years
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Goal: 50-54 = 10%; 55-59=20%; 60-69=45%; 70-79=25%
05
101520253035
50-54 55-59 60-64 65-69 70-74 75-79
Percent
Hysterectomy-E only Uterus-E+P
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
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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
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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
50-59 (baseline) 60-69 (baseline) 70-79 (baseline)
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Percent Normal Weight, Overweight, and Obese
0.4
25.5
12.5
6.7
0.7
29.9
21
8.94.2
34.7
20.3
35.3
05
10152025303540
<19 19-24.9 25-29.9 30-34.9 35.39.9 ≥40
Percent
Hysterectomy - E only Uterus-E+P
WHI HT: Baseline Body Mass Index (kg/m2)
Normal Overweight Obese I Obese II Obese III
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
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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 (baseline) 60-69 (baseline) 70-79 (baseline)
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3.1 6.8
23.9
2.3 4.5
19.5
38.9 34.943.4
22.8
01020304050
0-8 yrs someH.S.
HSdiplomaor GED
Somecollege
Collegedegree or
higher
Percent
Hyst-E only Uterus-E+P
WHI Hormone Trial Cohorts: Education Level
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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8.5
19.7
29.7
19.314.3
8.65.5
17.713.2
21.2
15
27.5
05
101520253035
<$10,000 $10,000-$19,999
$20,000-$34,999
$35,000-$49,999
$50,000-$74,999
$75,000+
Percent
Hyst-E only Uterus-E+P
WHI Hormone Trial Cohorts: Family Income
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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6.7 2.58.1
61.8
21
7.82.6
8.417.7
63.5
010203040506070
NeverPregnant
None 1 2 - 4 5+
Percent
Hysterectomy -E only Uterus-E+P
WHI Hormone Trial Cohorts: Number of Live Births
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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2.7
27.3
64.8
5.32.916.4
70.8
9.8
01020304050607080
Never hadterm
pregnancy
< 20 yrs 20-29 30+
Percent
Hysterectomy -E only Uterus-E+P
WHI Hormone Trial Cohorts: Age at 1st Birth
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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WHI E-alone (CEE) Trial: Reproductive History
• Bilateral Oophorectomy 40.7%
by Decade: 50-59 36.0%
60-69 42.5%
70-79 43.8%
• Age at Hysterectomy (by Decade: 50-, 60-, 70-)
< 40 39.8% (55.5%, 36.6%, 25.5%)
40-49 42.7% (38.3%, 46.2%, 41.8%)
50+ 17.5% (6.2%, 17.2%, 32.7%)
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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51.1
38.4
10.5
49.8
39.7
10.5
0
10
20
30
40
50
60
Never Smoked Past Smoker Current Smoker
Percent
Hysterectomy -E only Uterus-E+P
WHI Hormone Trial Cohorts: Smoking Status
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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WHI Hormone Trials: Smoking Status by AgeWHI Hormone Trials: Smoking Status by Age
47
38
15
39
11
37
5
4750
5558
50
5
40
10
41
15
38
0
10
20
30
40
50
60
Never Past Current Never Past Current Never Past Current
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
50-59 (baseline) 60-69 (baseline) 70-79 (baseline)
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13.723.9
62.4
11.617
71.4
01020304050607080
Never Drinker Past Drinker Current Drnker
Percent
Hysterectomy -E only Uterus-E+P
WHI Hormone Trial Cohorts: Alcohol Intake
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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21.7
45.8
14.6 17.918.2
42.9
15.823
0
10
20
30
40
50
No Activity Some Activity 2-< 4bouts/wk (≥moderate)
4+ bouts/wk(≥ moderate)
Percent
Hysterectomy -E only Uterus-E+P
WHI Hormone Trial Cohorts: Physical Activity
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
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WHI Hormone Trials: Physical Activity by AgeWHI Hormone Trials: Physical Activity by Age
25
1416
1516
15
202018
1617
2223
18
23
16
23
15
0
5
10
15
20
25
30
None 2-<4/wk 4+/wk None 2-<4/wk 4+/wk None 2-<4/wk 4+/wk
Percent
Hysterectomy- E only Uterus - E+P
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
50-59 (baseline) 60-69 (baseline) 70-79 (baseline)
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WHI Hormone Trials: Blood Pressure by AgeWHI Hormone Trials: Blood Pressure by Age
43 42
16
45
26
42
36
51
35
2322
2933
43
22
44
12
37
0
10
20
30
40
50
60
SBP ≤120
>120-140
SBP ≥140
SBP ≤120
>120-140
SBP ≥140
SBP ≤120
>120-140
SBP ≥140
Percent
Hysterectomy- E only Uterus - E+P
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
50-59 (baseline) 60-69 (baseline) 70-79 (baseline)
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WHI Hormone Trials: Diastolic Blood Pressure by AgeWHI Hormone Trials: Diastolic Blood Pressure by Age
89
11 9 6
92 92 9691 94
8 8 6
0102030405060708090
100
DBP <90 DBP ≥90 DBP <90 DBP ≥90 DBP <90 DBP ≥90
Percent
Hysterectomy- E only Uterus - E+P
Stefanick, Cochrane, Hsia, Barad, Liu, Johnson Ann Epidemiol 2003; 13: S78-S86
50-59 (baseline) 60-69 (baseline) 70-79 (baseline)
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14
54
88
2235
78
24
59
17
34
55
84
0102030405060708090
100
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)
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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)
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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)
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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)
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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)
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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)
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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)
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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
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0
10
20
30
40
50
50-59 60-69 70-790
10
20
30
40
50
<25 25-29.9 ≥30
Age (yrs)
% o
f E
nro
lled
Po
pu
lati
on
Prior HT Use
n=3310(30.8%)
n=4852(45.2%)
n=2577(24.0%)
n=5539 (51.6%)
n=3819(35.6%)
n=1377 (12.8%)
n=2206(20.7%)
n=3707(34.7%)
n=4759(44.6%)
Body Mass Index
Mean =63.6 yrs Mean =30.1 kg/m2
WHI E-Alone (CEE) Trial: Baseline CharacteristicsAge, BMI, Prior Hormone Therapy (HT) Use
0
20
40
60
Past Current Never
The Women’s Health Initiative Steering Committee: JAMA 2004; 291: 1701-1712
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Effects of CEE and Placebo on Disease Rates
0
1020
3040
5060
7080
90
StrokesBloodclots
HeartattacksColorectal
cancerDeaths BreastcancerHip
fractures
Number of cases per year
in 10,000 women
CEEPlacebo
WHI E-Alone (CEE) Trial: Absolute (annualized) Risk (6.8 Yrs)
The Women’s Health Initiative Steering Committee: JAMA 2004; 291: 1701-1712
Risk Benefit
P=.007 P=0.01P=.06
VTE: nsDVT
P=.03
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• 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)
– DeathsThe Women’s Health Initiative Steering Committee: JAMA 2004; 291: 1701-1712
WHI E-Alone Trial: Attributable Risk Summary
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18,845 Provided Consent and reported no hysterectomy
373,092 Women Initiated Screening
16,608 Randomized
Status on 04/30/02
Alive & Outcomes data submitted in last 18 months (n = 7968) 93.7%
Unknown Vital Status (n = 307) 3.6%
Deceased (n = 231) 2.7%
Status on 04/30/02
Alive & Outcomes data submitted in last 18 months (n = 7608) 93.9%
Unknown Vital Status (n = 276) 3.4%
Deceased (n = 218) 2.7%
CEE+MPA (N = 8506) Placebo (N = 8102)
WHI E+P Trial: Participant Retention
Writing Group for the Women’s Health Initiative Steering Committee: JAMA 2002; 288: 321-333
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Writing Group for the Women’s Health Initiative. JAMA. 2002;288:321-333.
0
10
20
30
40
50
50-59 60-69 70-790
10
20
30
40
50
<25 25-29.9 ≥30
Age (yrs)
% o
f E
nro
lled
Po
pu
lati
on
Prior HT Use
n=5522(33.3%)
n=7510(45.2%)
n=3576(21.5%)
n=12,304 (74.1%)
n=3262(19.6%)
n=1035 (6.2%)
n=5058(30.6%)
n=5826(35.3%)
n=5636(34.1%)
Body Mass Index
Mean =63.3 yrs Mean =28.5 kg/m2
WHI E+P Trial: Baseline Age, BMI, Prior HT Use
0
20
40
60
80
Past Current Never
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WHI E+P (CEE) Trial: Absolute (annualized) Risk (5.6 Yrs)
Effects of Estrogen-Plus-Progestin and Placebo on Disease Rates
01020
30405060
708090
Heartattacks StrokesBloodclots
Breastcancer
Colorectalcancer
Hip
fracturesDeaths
Number of cases per year
in 10,000 women
CEE+MPA
Placebo
Risks Benefits Neutral
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WHI E+P (CEE+ MPA) Trial: Key Findings average of 5.2 years of follow-up (updated to 5.6 years)
In white, findings which were similar in CEE only trial
• does not reduce (increases) heart disease
• increases the risk of stroke
• increases blood clots in the lungs + legs (DVTs)
• decreases the risk of hip fracture
• increases breast cancer risk
• decreases colorectal cancer diagnoses
• does not affect endometrial cancer
• no affect on overall mortality (death)
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Effects of Estrogen-Alone and Placebo on Disease Rates
0
10
20
30
40
50
60
70
80
90
Heartattacks StrokesBloodclots
Breastcancer
Colorectalcancer
Hip
fracturesDeaths
Number of cases per year
in 10,000 women
CEEPlacebo
Effects of Estrogen-Plus-Progestin and Placebo on Disease Rates
0102030405060708090
Heartattacks StrokesBloodclots
Breastcancer
Colorectalcancer
Hip
fracturesDeaths
Number of cases per year
in 10,000 women
CEE+MPA
Placebo
WHI E+P and E-Alone Trials: Absolute (annualized) Risk
Risks Benefits
Risk BenefitRisk? Benefit?