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Women’s Health Initiative: HRT TrialBaseline Data and Update on Follow-up
Marcia L. Stefanick, Ph.D. Marcia L. Stefanick, Ph.D.
Associate Professor of MedicineAssociate Professor of Medicine and of Obstetrics and Gynecologyand of Obstetrics and Gynecology
Stanford University School of Medicine, Stanford, CAStanford University School of Medicine, Stanford, CA
Principal Investigator of Stanford WHI Clinical CenterPrincipal Investigator of Stanford WHI Clinical Center
Chair of WHI Steering CommitteeChair of WHI Steering Committee
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Women’s Health InitiativeBaseline Monograph: HRT Chapter
Marcia L. StefanickMarcia L. Stefanick, PhD , PhD (Stanford PI)
Barbara B. CochraneBarbara B. Cochrane, RN, PhD , RN, PhD (FHCRC)
Judith HsiaJudith Hsia, MD , MD (GWU PI)
David H. BaradDavid H. Barad, MD , MD (Einstein)
James H. LiuJames H. Liu, MD , MD (Cincinnati PI)
Susan J. JohnsonSusan J. Johnson, MD , MD (Iowa)
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WHI CT Sample Size, Outcomes, Follow-upWHI CT Sample Size, Outcomes, Follow-up Women, aged 50-79 Women, aged 50-79 TotalTotal CT = 68,133 CT = 68,133
Diet Modification (DM) Trial Primary Outcomes: Breast & Colorectal Cancer Secondary Outcome: Coronary Heart Disease (CHD)
Hormone (HRT) Trial Primary Outcome: CHD Secondary Outcomes: Hip Fracture, Breast Cancer Ancillary Study: Memory
11.8% Overlap
Average Follow-up 8.5 years
Average 8.4 years
DM
48,836
HRT27, 347
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Background for HRT/CHD hypothesisBackground for HRT/CHD hypothesis
LRC LRC Prevalence StudyPrevalence Study (‘83,’87)(‘83,’87) Nurses’ Health Study Nurses’ Health Study (‘85, ‘91)(‘85, ‘91) Framingham Study Framingham Study (‘85)-reversed(‘85)-reversed Nurses’ Nurses’ Health Study Health Study (‘97) (‘97) PERTPERT
Survival benefit diminishes with longer duration use; is lower for women at low risk for CHD - NEJM ‘97: 336; 1769
Many Observational Studies Many Observational Studies HRT users vs nonusers (generally): less likely to smoke, leaner, more physically active, healthier, more educated, higher SES, visit MDs more often, at lower CVD risk
WHI (2005)
PEPI PEPI (‘95)(‘95) healthyhealthy, aged 45-64, aged 45-64. . HRT improved HDL-C (ERT > PERT) HRT improved HDL-C (ERT > PERT) & LDL-C& LDL-C + + fibrinogenfibrinogen; ; incr TG, CRPincr TG, CRP..
HERS HERS (‘98) (‘98) prior CHD (+ uterus), prior CHD (+ uterus), aged<80.aged<80. PERTPERT for for MI: No benefit MI: No benefit @@ 4 yrs; 4 yrs; incr.incr. 1st yr, 1st yr, decr.decr. 4-5 yrs; 4-5 yrs; incr incr VTE (DVTVTE (DVT&&PE),Gallbladder D.PE),Gallbladder D.
ERAERA (‘00) (‘00) angiographicangiographic CHD. CHD. No No ERT or PERTERT or PERT benefitbenefit,aver 3.2 yr,aver 3.2 yr
PHASE(‘00); (‘00); [WAVE?; WELL-HART?][WAVE?; WELL-HART?] EPATEPAT LDL≥ 130;if >160,lipid-lowering--No WESTWEST(‘01)(‘01) recent stroke or TIA - recent stroke or TIA - NoNo WHI (2005) women aged 50-79 women aged 50-79
Observational Studies Clinical Trials
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ERT10,739
WHI HRT Sample Size, Outcomes, Follow-upWHI HRT Sample Size, Outcomes, Follow-up Women, aged 50-79 Women, aged 50-79 TotalTotal HRT = 27,347 HRT = 27,347
Hormone (HRT) Trial Primary Outcome: Coronary Heart Disease Secondary Outcomes: Hip Fracture; Other Fractures Breast & Endometrial Cancers WHI Memory Study (WHIMS) - for women 65+ - Memory
Average Follow-up 8.4 years
Average 8.4 years
PERT16,608
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WHI HRT Trial WHI HRT Trial (N=27,347):(N=27,347): Treatments TreatmentsAdherence < 80% activates Intensive Adherence ProgramAdherence < 80% activates Intensive Adherence Program
Estrogen with Progestin (50%)Conjugated Equine Estrogen (CEE) - 0.625 mg/day +
Medroxyprogesterone Acetate - 2.5 mg/day (daily MPA)or
Placebo (50%)
Women with a Uterus (55% by design): Actual = 60.7% (N=16,608)
Women with a Hysterectomy (45%): Actual = 39.3% (N=10,739)
Estrogen only (50%)Conjugated Equine Estrogen (CEE) - 0.625 mg/day
orPlacebo (50%)
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Goal: 50-54 = 10%; 55-59=20%; 60-69=45%; 70-79=25%
12.5
19.822.9 22.3
15.7
6.8
05
101520253035
50-54 55-59 60-64 65-69 70-74 75-79
Perc
ent
HystX-ERT Uterus-PERT HRT total
WHI HRT: Baseline Age DistributionWHI HRT: Baseline Age DistributionMean Mean ±± SDSD: : HystX-ERT = 63.6HystX-ERT = 63.6 ± 7.3± 7.3; ; Uterus-PERT = 63.3Uterus-PERT = 63.3 ± 7.1± 7.1
60-69ERT=45%; PERT=45%
70-79 ERT=24%; PERT=22%
50-59ERT=31%; PERT=33%
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WHI HRT: Minority Distribution HystX: 2657HystX: 2657/10,739/10,739 (24.7%)(24.7%) Uterus: N = 2663 Uterus: N = 2663/16,608/16,608 (16.0%)(16.0%)
Total HRT: N = 5320Total HRT: N = 5320/27,347/27,347 (19.5%) (19.5%)
10.0
5.6
1.90.5
1.4
0.0
2.04.0
6.08.0
10.0
12.014.0
16.018.0
20.0
Blacks Hispanic Asian/PI Native Am Other
Pe
rce
nt
HysterX(75.3% White) Uterus (84.0 % ) HRT total (80.5%)
BlacksN=2741
HispanicN=1543
Asian/PIN=527
Nat. Amer.N=131
Total Numbers of Minority Women in HRT Trial
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Total HRT Goal: 50-59=30% 60-69=45% 70-79=25%
25
46
29
14
4244
9
38
54
22
4335
0
20
40
60
50-59 60-69 70-79
Per
cent
White Black Hispanic Asian/PI
WHI HRT: Mean WHI HRT: Mean (± SD)(± SD) Baseline Age DistributionBaseline Age DistributionWhiteWhite: : 63.963.9±7.1±7.1 BlackBlack: : 61.361.3±7.0 ±7.0 HispanicHispanic: : 59.759.7±6.4±6.4 Asian/PIAsian/PI: : 63.263.2±7.5±7.5
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WHI HRT: Differences among Minority GroupsWhites, N=22,027; Black, N = 2741; Hispanics, N = 1543; Asian/PI, N = 527
39
61
37
6359
4142
58
31
69
0
10
20
30
40
50
60
70
HystX - ERT No HystX - PERT
Pe
rce
nt
Total . WhitesBlacks Hispanic Asian/PI
Total Percent with Hysterectomy by Ethnic Group
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WHI HRT: Age by Uterine Status and EthnicityWhites, N=22,027; Black, N = 2741; Hispanics, N = 1543; Asian/PI, N = 527
63.6 64.3
61.663.2
59.7
63.2
59.660.9
63.763.3
5052545658606264666870
Total White Black Hispanic Asian/PI
Ag
e (
ye
ars
)
HystX - ERT No HystX - PERT
Mean Age by Ethnic Group and Uterine Status
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WHI HRT: Body Mass Index (kg/m2) by Uterine StatusWhites, N=22,027; Black, N=2741; Hispanics, N=1543; Asian/PI, N=527
30.126.8
32.229.7
30.5
25.228.5 28.3
31.0 29.5
0
5
10
15
20
25
30
35
Total White Black Hispanic Asian/PI
kg/m
2
HystX - ERT No HystX - PERT
Mean BMI by Ethnic Group and Uterine Status
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2.6 5.4
20.8
40.7
30.6
05
101520253035404550
Perc
ent
HysterX-ERT Uterus-PERT HRT Total
WHI HRT: Education LevelWHI HRT: Education Level
Some College67.4% ERT; 73.8% PERT
< H.S. Diploma Equiv.9.9% ERT; 6.8% PERT
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Percent Normal Weight, Overweight and Obese
0.6
22.7
10.35.2
35.126.1
05
10152025303540
<19 19-24.9 25-29.9 30-34.9 35.39.9 ≥40
Per
cent
Hyst-ERT Uterus-PERT HRT Total
WHI HRT: Baseline Body Mass Index (kg/mWHI HRT: Baseline Body Mass Index (kg/m22)) Mean BMIMean BMI: : ERT = 30.1ERT = 30.1 ± 6.2;± 6.2; PERT = 28.5PERT = 28.5 ± 5.9± 5.9;; HRT = 29.1HRT = 29.1 ± 6.1± 6.1
Normal Overweight Obese I Obese II Obese III
% Overwt+Obese ERT: 79.3 % PERT: 69.4 % HRT: 73.3 %
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19.615.3
44.1
21.0
05
10152025303540455055
No Activity Some 2- <4/wkModerate
≥4X/wk
Perc
ent
HystX-ERT Uterus-PERT HRT Total
WHI HRT:Moderate & Strenuous ExerciseWHI HRT:Moderate & Strenuous Exercise(≥ 20 minutes/bout)(≥ 20 minutes/bout)
No Activity or ≤1X/wkNo Activity or ≤1X/wk63.7% of HRT63.7% of HRT
RecommendedRecommended
by CDCby CDC: 21% : 21%
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32.1 33.523.1
11.2
50.339.2
10.5
01020304050607080
Perc
ent
HystX-ERT Uterus-PERT Total HRT
WHI HRT:Alcohol Intake and SmokingWHI HRT:Alcohol Intake and Smoking
Alcohol Intake Smoking Status
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6.7
16.8
28.3
20.416.4
11.4
05
101520253035
Perc
ent
HysterX-ERT Uterus-PERT Total HRT
WHI HRT: Family IncomeWHI HRT: Family Income
< $20,00028.2% ERT20.5% PERT
> $50,00022.9% ERT30.9% PERT
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3.8
17.7 20
58.5
0
10
20
30
40
50
60
70
80
Never married DivorcedSeparated
Widowed Marriage (likeRelationship)
Perc
ent
HystX-ERT Uterus-PERT Total HRT
WHI HRTWHI HRT:Marital Status:Marital Status
Divorced or Separated Widowed
Never Married
Marriage-like
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WHI CaD: Outcomes, Relationship to CTWHI CaD: Outcomes, Relationship to CT
Calcium + Vitamin D (CaD) Primary Outcome: Hip Fracture Secondary Outcomes: Other Fractures, Colorectal Cancer
CaD36,282
at 1st (or 2nd) Annual Visit
Total CT = Total CT = 68,133
Total HRT = Total HRT = 27,347(40.1% of CT)
53.3% of CT
DM48,836
ERT10,739
PERT16,608
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WHI Clinical Trials: Percent OverlapWHI Clinical Trials: Percent Overlap Total CT = 68,133 (53.3 % are in CaD)Total CT = 68,133 (53.3 % are in CaD)
29.4 % of HRT are in DM
CaD 36,282
59.7 %*
57.5 %*
19.5% ERT are in DM + CaD
17.6% PERT are in DM + CaD
44.3%CaD are
in HRT Trial
DM48,836
PERT16,608
ERT10,739
28.1% of PERT are in DM
31.6 % of ERT are in DM
58.8% HRT are in CaD
18.4% HRT are in DM + CaD
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WHI HRT (N=27,347) & CaD (N=36,282): Follow-up Clinic Visits
Percent of Annual Visits Due for HRT and CaD
58.1
28.0
10.5
90.6
12
31
62
9291
0102030405060708090
100
AV1 AV2 AV3 AV4 AV5 AV6
Per
cent
Total HRT HystX-ERT Uterus-PERT CaD
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WHI HRT & CaD: Follow-up Clinic Visits
Percent (of Due) Annual Visits Conducted in HRT & CaD
97 95 94 92 92 9198 97 95 94 94
0102030405060708090
100
AV1 AV2 AV3 AV4 AV5 AV6
Per
cent
Total HRT HystX-ERT Uterus-PERT CaD
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WHI HRT: Follow-up
Percent Stopped HRT During Interval
109
76
54
02468
1012
AV1 AV2 AV3 AV4 AV5 AV6
Pe
rce
nt
Total HRT HystX-ERT Uterus-PERT
Cumulative, as of 2/01 = 33.5%
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WHI HRT: Follow-up Clinic VisitsPercent of Women with Pill Counts taking > 80% Pills
Note: % with pill counts noted above columns
0102030405060708090
100
AV1 AV2 AV3 AV4 AV5 AV6
Pe
rce
nt
HystX-ERT Uterus-PERT
94% 90% 92% 92% 91% 92%
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WHI HRT: Follow-up Clinic Visits
Percent < 50% & 50-80% Pill-taking Rate in Interval
0
2
4
6
8
10
12
AV1 AV2 AV3 AV4 AV5 AV5
Pe
rce
nt
HystX-ERT < 50% Uterus-PERT < 50%HystX 50-80% Uterus 50-80%
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WHI HRT: Treated Hypertension by Ethnicity and Uterine Status
05
101520253035404550
Total White Black Hispanic Asian/PI
Perc
ent
Hysterectomy No HystX
Treated Hypertension by Uterine Status
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HRT: High Blood Pressure* by Ethnicity and Uterine Status
* (Systolic BP>140 mmHg; Diastolic BP>90 mmHg)
0
5
10
15
20
25
30
35
40
Total White Black Hispanic Asian/PI
Perc
ent
HystX- High SBP No HystX- High SBP
HystX- High DBP No HystX- High DBP
High SBP and DBP (Baseline Clinic Visit) by Uterine Status
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WHI HRT: Treated Diabetes by Ethnicity and Uterine Status
0
2
4
6
8
10
12
14
Total White Black Hispanic Asian/PI
Pe
rce
nt
Hysterectomy No HystX
Treated Diabetes (per Questionnaire)
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WHI HRT: High Cholesterol requiring Pills by Ethnicity and Uterine Status
0
5
10
15
20
25
30
Total White Black Hispanic Asian/PI
Pe
rce
nt
Hysterectomy No HystX
High Blood Cholesterol requiring Pills
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WHI HRT: History of MI or CABG/PTCAby Uterine Status and Ethnicity
00.5
11.5
22.5
33.5
44.5
5
Total White Black Hispanic Asian/PI
Pe
rce
nt
HystX-prior MI No HystX-prior MI
HystX-prior CABG/PTCA No HystX-prior CABG/PTCA
Positive Response to MI or CABG/PTCA Ever
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WHI HRT: History of Stroke by Uterine Status and Ethnicity
0
0.5
1
1.5
2
2.5
3
Total White Black Hispanic Asian/PI
Pe
rce
nt
Hysterectomy No HystX
Positive Response to Stroke Ever
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WHI HRT: Age at First Birth (%) by Uterine Status and Ethnicity
05
101520253035404550
Total White Black Hispanic Asian/PI
Pe
rce
nt
HystX 1st Birth < 20 yrs old No HystX 1st Birth < 20 yrs old
HystX-1st Birth ≥ 30 yrs old No HystX-1st Birth ≥ 30 yrs old
First Birth < 20 Yrs Age or ≥ 30 Yrs of age
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WHI HRT: No Live Births by Uterine Status and Ethnicity
0123456789
10
Total White Black Hispanic Asian/PI
Pe
rce
nt
Hysterectomy No HystX
No Live Births (No term pregnancy)
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WHI HRT: Oral Contraceptive Use and Duration by Ethnicity and Uterine Status
0
5
10
15
20
25
Total White Black Hispanic Asian/PI
Pe
rce
nt
HystX Used OC < 5 yrs No HystX Used OC < 5 yrsHystX Used OC 5-10 yrs No HystX Used OC 5-10 yrsHystX Used OC ≥ 10 yrs No HystX Used OC ≥ 10 yrs
Percent Using OC for <5, 5-<10 or ≥ 10 yrs
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HRT Use at Baseline and Time Since last used (%) by Ethnicity and Uterine Status
02468
101214161820
Total White Black Hispanic Asian/PI
Pe
rce
nt
HystX- Current No HystX- Current
HystX- Used < 5 yrs ago No HystX- Used < 5 yrs ago
Percent Using HRT Currently or < 5 yrs ago
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HRT Use at Baseline and Time Since last used (%) by Ethnicity and Uterus Status
0
5
10
15
20
25
Total White Black Hispanic Asian/PI
Pe
rce
nt
HystX Used 5-<10 yrs ago No HystX Used 5-<10 yrs ago
HystX Used ≥ 10 yrs ago No HystX Used ≥ 10 yrs ago
Percent Using HRT 5 -<10 or ≥ 10 yrs ago