WHI CT Sample Size, Outcomes, Follow-up Women, aged 50-79 Total CT = 68,133

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

)


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


kg/m

2


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%


%

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


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


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


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



Treated Diabetes (per Questionnaire)

Per

cent

WHI HRT: High Cholesterol requiring Pills by Ethnicity and Uterine Status

0

5

10

15

20

25

30



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


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



Positive Response to Stroke Ever

Per

cent

WHI HRT: Age at First Birth (%) by Uterine Status and Ethnicity

0

10

20

30

40

50


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



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


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


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


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

WHI CT Sample Size, Outcomes, Follow-up Women, aged 50-79 Total CT = 68,133

Documents

Transcript of WHI CT Sample Size, Outcomes, Follow-up Women, aged 50-79 Total CT = 68,133