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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 Total CT = 68,133Total 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
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) healthy, aged 45-64healthy, aged 45-64. . HRT HRT improved HDL-C (ERT > PERT) & LDL-Cimproved HDL-C (ERT > PERT) & LDL-C + + fibrinogenfibrinogen; ; incr TG, CRPincr TG, CRP..
HERS HERS (‘98) prior CHD (+ uterus), aged<80. (‘98) prior CHD (+ uterus), 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 VTE (DVT(DVT&&PE),Gallbladder D.PE),Gallbladder D.
ERAERA (‘00) (‘00) angiographicangiographic CHD. CHD. No ERT or No ERT or PERTPERT 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
•Background for HRT Hypothesis
ERT10,739
WHI HRT Sample Size, Outcomes, Follow-upWHI HRT Sample Size, Outcomes, Follow-up Women, aged 50-79 Women, aged 50-79 Total HRT = 27,347Total 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
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%)
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 ± SD: Mean ± SD: 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%
Goal: 50-54 = 10%; 55-59=20%; 60-69=45%; 70-79=25%
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
2.0
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
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
Per
cent
Total HRT Goal: 50-59=30% 60-69=45% 70-79=25%
25
46
29
14
4244
9
38
54
22
43
35
0
10
20
30
40
50
60
50-59 60-69 70-79
White Black Hispanic Asian/PI
WHI HRT: Mean WHI HRT: Mean (± SD) (± SD) Baseline Age DistributionBaseline Age DistributionWhite: 63.9±7.1 Black: 61.3±7.0 Hispanic: 59.7±6.4 Asian/PI: White: 63.9±7.1 Black: 61.3±7.0 Hispanic: 59.7±6.4 Asian/PI:
63.2±7.563.2±7.5
Per
cent
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
Per
cen
t
Total Whites Blacks Hispanic Asian/PI
Total Percent with Hysterectomy by Ethnic Group
WHI HRT: Age by Uterine Status and EthnicityWhite, N=22,027; Black, N = 2741; Hispanic, N = 1543; Asian/PI, N = 527
63.6 64.3
61.663.2
59.7
63.2
59.660.9
63.763.3
50
54
58
62
66
70
Total White Black Hispanic Asian/PI
Ag
e (
years
)
HystX - ERT No HystX - PERT
Mean Age by Ethnic Group and Uterine Status
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
5.4
20.8
40.7
30.6
2.6
0
10
20
30
40
50
Gr 0-8 Gr 9-11 HS/GED SomeCollege
Per
cent
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
> CollegeDegree
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 %
19.615.3
44.1
21.0
-5
5
15
25
35
45
55
No Activity Some 2 - <4/wkModerate
= >4/wk
Per
cent
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
RecommendedRecommendedby CDC: 21% by CDC: 21%
10.5
39.250.3
11.2
23.1
33.532.1
0
20
40
60
80
100
HystX-ERT Uterus-PERT Total HRT
WHI HRT:Alcohol Intake and SmokingWHI HRT:Alcohol Intake and Smoking
Alcohol Intake Smoking Status
None/Past <1 drinks/wk 1 to < 7/wk 7+ drinks/wkNever
Smoked Past SmokerCurrent Smoker
%
6.7
16.8
28.3
20.4
16.4
11.4
0
5
10
15
20
25
30
35
HysterX-ERT Uterus-PERT Total HRT
WHI HRT: Family IncomeWHI HRT: Family Income< $20K ERT (28.2%); PERT (20.5%) > $50K ERT (22.9%) PERT (30.9%)
< $10K
$10K - $19K
$20K - < $35K
$35K - < $50K
$50K - < $75K
> $75K
%
17.7 20
58.5
3.8
0
10
20
30
40
50
60
70
80
HystX-ERT Uterus-PERT Total HRT
WHI HRTWHI HRT:Marital Status:Marital Status
Divorced or
Separated Widowed
Never Married
Married
%
WHI CaD: End-Points, Relationship to CTWHI CaD: End-Points, Relationship to CT
Calcium + Vitamin D (CaD) Primary End-Point: Hip Fracture Secondary End-Points: 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
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%CaDare 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
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
0
20
40
60
80
100
AV1 AV2 AV3 AV4 AV5 AV6Total HRT HystX-ERT Uterus-PERT CaD
%
WHI HRT & CaD: Follow-up Clinic Visits
97 95 9492 92 91
98 97 95 94 94
0
20
40
60
80
100
Total HRT HystX-ERT Uterus-PERT CaD
Percent (of Due) Annual Visits Conducted in HRT & CaD
%
AV1 AV2 AV3 AV4 AV5 AV6
WHI HRT: Follow-upPercent Stopped HRT During Interval
109
76
54
0
2
4
6
8
10
12
Total HRT HystX-ERT Uterus-PERT
Cumulative, as of 2/01 = 33.5%
AV1 AV2 AV3 AV4 AV5 AV6
%
WHI HRT: Follow-up Clinic VisitsPercent of Women with Pill Counts taking > 80% Pills
(Note: % with pill counts noted above columns)
0
20
40
60
80
100
AV1 AV2 AV3 AV4 AV5 AV6
Per
cent
HystX-ERT Uterus-PERT
94% 90% 92% 92% 91% 92%
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
Per
cent
HystX-ERT < 50% Uterus-PERT < 50%HystX 50-80% Uterus 50-80%
WHI HRT: Follow-up Clinic Visits
WHI HRT: Treated Hypertension by Ethnicity and Uterine Status
0
10
20
30
40
50
Total White Black Hispanic Asian/PI
Hysterectomy No HystX
Treated Hypertension by Uterine Status
Per
cent
HRT: High Blood Pressure* by Ethnicity and Uterine Status
* (Systolic BP>140 mmHg; Diastolic BP>90 mmHg)
0
10
20
30
40
Total White Black Hispanic Asian/PIHystX- High SBP No HystX- High SBP
HystX- High DBP No HystX- High DBP
High SBP and DBP (Baseline Clinic Visit) by Uterine Status%
WHI HRT: Treated Diabetes by Ethnicity and Uterine Status
0
2
4
6
8
10
12
14
Total White Black Hispanic Asian/PI
Hysterectomy No HystX
Treated Diabetes (per Questionnaire)
Per
cent
WHI HRT: High Cholesterol requiring Pills by Ethnicity and Uterine Status
0
5
10
15
20
25
30
Total White Black Hispanic Asian/PI
Hysterectomy No HystX
High Blood Cholesterol requiring Pills
Per
cent
WHI HRT: History of MI or CABG/PTCAby Uterine Status and Ethnicity
0
1
2
3
4
5
Total White Black Hispanic Asian/PI
HystX-prior MI No HystX-prior MI
HystX-prior CABG/PTCA No HystX-prior CABG/PTCA
Positive Response to MI or CABG/PTCA Ever
Per
cent
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
Hysterectomy No HystX
Positive Response to Stroke Ever
Per
cent
WHI HRT: Age at First Birth (%) by Uterine Status and Ethnicity
0
10
20
30
40
50
Total White Black Hispanic Asian/PI
No HystX No term pregancy HystX 1st Birth < 20 yrs oldNo HystX 1st Birth < 20 yrs old HystX-1st Birth > 30 yrs oldNo HystX-1st Birth > 30 yrs old
First Birth < 20 Yrs Age or = 30 Yrs of age
Per
cent
WHI HRT: No Live Births by Uterine Status and Ethnicity
0
2
4
6
8
10
Total White Black Hispanic Asian/PI
Hysterectomy No HystX
No Live Births (No term pregnancy)
Per
cent
WHI HRT: Oral Contraceptive Use and Duration by Ethnicity and Uterine Status
0
5
10
15
20
25
Total White Black Hispanic Asian/PI
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 yrsHystX-OC >10 yrs No HystX OC >10 yrs
Percent Using OC for <5, 5-<10 or > 10 yrsP
erce
nt
HRT Use at Baseline and Time Since last used (%) by Ethnicity and Uterine Status
0
4
8
12
16
20
Total White Black Hispanic Asian/PI
HystX- Current No HystX- Current
HystX- Used < 5 yrs ago No HystX- Used < 5 yrs ago
Percent Using HRT Currently or < 5 yrs ago
Per
cent
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
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
Per
cent
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