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

WHI CT Sample Size, Outcomes, Follow-up Women, aged 50-79 Total CT = 68,133. Average Follow-up 8.5 years. Diet Modification (DM) Trial Primary Outcomes: Breast & Colorectal Cancer Secondary Outcome: Coronary Heart Disease (CHD) Hormone (HRT) Trial Primary Outcome : CHD

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

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  1. WHI CT Sample Size, Outcomes, Follow-upWomen, aged 50-79 Total CT = 68,133 Average Follow-up 8.5 years 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 DM 48,836 11.8% Overlap HRT 27, 347 Average 8.4 years

  2. Background for HRT Hypothesis • Observational Studies • Clinical Trials • LRC Prevalence Study(‘83,’87) • Nurses’ Health Study (‘85, ‘91) • Framingham Study (‘85)-reversed • Nurses’ Health Study (‘97) PERT • Survival benefit diminishes with longer duration use; is lower for women at low risk for CHD - NEJM ‘97: 336; 1769 • 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 (‘95)healthy, aged 45-64. HRT improved HDL-C (ERT > PERT) & LDL-C + fibrinogen; incr TG, CRP. • HERS (‘98) prior CHD (+ uterus), aged<80. PERT for MI: No benefit@ 4 yrs; incr. 1st yr, decr. 4-5 yrs; incr VTE (DVT&PE),Gallbladder D. • ERA(‘00) angiographic CHD. No ERT or PERTbenefit,aver 3.2 yr • PHASE(‘00); [WAVE?; WELL-HART?] • EPATLDL≥ 130;if >160,lipid-lowering-No • WEST(‘01)recent stroke or TIA - No • WHI (2005) women aged 50-79

  3. WHI HRT Sample Size, Outcomes, Follow-upWomen, aged 50-79 Total 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 PERT 16,608 ERT 10,739 Average 8.4 years

  4. WHI HRT Trial (N=27,347): Treatments Adherence < 80% activates Intensive Adherence Program Women with a Uterus (55% by design): Actual = 60.7% (N=16,608) 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 Hysterectomy (45%): Actual = 39.3% (N=10,739) Estrogen only (50%) Conjugated Equine Estrogen (CEE) - 0.625 mg/day or Placebo (50%)

  5. WHI HRT: Baseline Age DistributionMean ± SD: HystX-ERT = 63.6 ± 7.3; Uterus-PERT = 63.3 ± 7.1 Goal: 50-54 = 10%; 55-59=20%; 60-69=45%; 70-79=25% 50-59 ERT=31%; PERT=33% 60-69 ERT=45%; PERT=45% 70-79 ERT=24%; PERT=22%

  6. WHI HRT: Minority DistributionHystX: 2657/10,739(24.7%) Uterus: N = 2663/16,608(16.0%)Total HRT: N = 5320/27,347 (19.5%) Percent

  7. WHI HRT: Mean (± SD) Baseline Age DistributionWhite: 63.9±7.1 Black: 61.3±7.0 Hispanic: 59.7±6.4 Asian/PI: 63.2±7.5 Percent

  8. WHI HRT: Differences among Minority GroupsWhites, N=22,027; Black, N = 2741; Hispanics, N = 1543; Asian/PI, N = 527

  9. WHI HRT: Age by Uterine Status and EthnicityWhite, N=22,027; Black, N = 2741; Hispanic, N = 1543; Asian/PI, N = 527

  10. WHI HRT: Body Mass Index (kg/m2) by Uterine StatusWhites, N=22,027; Black, N=2741; Hispanics, N=1543; Asian/PI, N=527

  11. WHI HRT: Education Level < H.S. Diploma Equiv. 9.9% ERT; 6.8% PERT Some College 67.4% ERT; 73.8% PERT > College Degree

  12. WHI HRT: Baseline Body Mass Index (kg/m2)Mean BMI: ERT = 30.1± 6.2;PERT = 28.5± 5.9;HRT = 29.1± 6.1 % Overwt+Obese ERT: 79.3 % PERT: 69.4 % HRT: 73.3 % Normal Overweight Obese I Obese II Obese III

  13. WHI HRT:Moderate & Strenuous Exercise(≥20 minutes/bout) No Activity or ≤1X/wk 63.7% of HRT Recommended by CDC: 21%

  14. WHI HRT:Alcohol Intake and Smoking % Alcohol Intake Smoking Status Current Smoker Never Smoked None/Past <1 drinks/wk 1 to < 7/wk 7+ drinks/wk Past Smoker

  15. WHI HRT: Family Income < $20K ERT (28.2%); PERT (20.5%) > $50K ERT (22.9%) PERT (30.9%) % $35K - < $50K $10K - $19K > $75K < $10K $20K - < $35K $50K - < $75K

  16. WHI HRT:Marital Status % Married Divorced or Separated Widowed Never Married

  17. WHI CaD: End-Points, Relationship to CT Total CT = 68,133 Total HRT = 27,347 (40.1% of CT) Calcium + Vitamin D (CaD) Primary End-Point: Hip Fracture Secondary End-Points: Other Fractures, Colorectal Cancer PERT 16,608 DM 48,836 at 1st (or 2nd) Annual Visit CaD 36,282 53.3% of CT ERT 10,739

  18. WHI Clinical Trials: Percent Overlap Total CT = 68,133 (53.3 % are in CaD) 17.6% PERT are in DM + CaD 28.1% of PERT are in DM PERT 16,608 58.8% HRT are in CaD 59.7 %* DM 48,836 CaD 36,282 57.5 %* ERT 10,739 44.3%CaD are in HRT Trial 31.6 % of ERT are in DM 19.5% ERT are in DM + CaD 29.4 % of HRT are in DM 18.4% HRT are in DM + CaD

  19. WHI HRT (N=27,347) & CaD (N=36,282): Follow-up Clinic Visits %

  20. WHI HRT & CaD: Follow-up Clinic Visits Percent (of Due) Annual Visits Conducted in HRT & CaD % AV1 AV2 AV3 AV4 AV5 AV6

  21. WHI HRT: Follow-up Percent Stopped HRT During Interval % Cumulative, as of 2/01 = 33.5% AV1 AV2 AV3 AV4 AV5 AV6

  22. WHI HRT: Follow-up Clinic Visits Percent of Women with Pill Counts taking > 80% Pills (Note: % with pill counts noted above columns) 94% 90% 92% 92% 91% 92%

  23. WHI HRT: Follow-up Clinic Visits WHI HRT: Follow-up Clinic Visits

  24. WHI HRT: Treated Hypertensionby Ethnicity and Uterine Status Percent

  25. HRT: High Blood Pressure*by Ethnicity and Uterine Status* (Systolic BP>140 mmHg; Diastolic BP>90 mmHg) %

  26. WHI HRT: Treated Diabetes by Ethnicity and Uterine Status Percent

  27. WHI HRT: High Cholesterol requiring Pillsby Ethnicity and Uterine Status Percent

  28. WHI HRT: History of MI or CABG/PTCAby Uterine Status and Ethnicity Percent

  29. WHI HRT: History of Stroke by Uterine Status and Ethnicity Percent

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

  31. WHI HRT: No Live Birthsby Uterine Status and Ethnicity Percent

  32. WHI HRT: Oral Contraceptive Use and Duration by Ethnicity and Uterine Status Percent

  33. HRT Use at Baseline and Time Since last used (%) by Ethnicity and Uterine Status Percent

  34. HRT Use at Baseline and Time Since last used (%) by Ethnicity and Uterus Status Percent

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