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WHI Estrogen+Progestin Trial

Further Findings of the Women’s Health Initiative of Risks and Benefits of Estrogen plus Progestin in Healthy Postmenopausal Women. WHI Estrogen+Progestin Trial. History Benefit Primary Outcome - CHD Secondary Outcome – Hip Fracture Adverse

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WHI Estrogen+Progestin Trial

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  1. Further Findings of the Women’s Health Initiative of Risks and Benefits of Estrogen plus Progestin in HealthyPostmenopausal Women

  2. WHI Estrogen+Progestin Trial History Benefit • Primary Outcome - CHD • Secondary Outcome – Hip Fracture Adverse • Primary Outcome – Breast Cancer • Secondary Outcome – Other Cancers

  3. WHI Estrogen+Progestin Trial History • Recruitment 161,809 – 1993-1998 • Termination E + P trial by DSMB - 2002 • Termination E-alone trial by NIH - 2004

  4. Women’s Health Initiative Trial of Estrogen + Progestin Methods

  5. WHI Hormone Program Study Population: Inclusion criteria • Age 50-79 at baseline • Post menopausal, defined as: • No bleeding for >6 months (>12 months for 50-54 years old) • Current / prior use of menopausal hormones • Post hysterectomy with symptoms • Likely to reside in the clinic area for 3 years • Willing to provide written informed consent • Willing to take placebo for 8.5 years

  6. WHI Hormone Program Design Conjugated equine estrogen (CEE) 0.625 mg/d YES N= 10,739 Placebo Hysterectomy CEE 0.625 mg/d + medroxyprogesterone acetate (MDA) 2.5 mg/d NO N= 16,608 Placebo

  7. WHI Estrogen+Progestin Trial Outcome Ascertainment • Initial report of all hospitalizations and selected other events by self-administered questionnaire • If events reported, more detailed information collected by structured questionnaire • Medical records obtained • Adjudication by local physicians who were centrally trained and blinded to treatment assignments and participants’ symptoms • Central adjudication of key outcomes in progress

  8. Women’s Health Initiative Trial of Estrogen + Progestin Results

  9. Attributable Risk Summary • Excess risk per 10,000 person-years on E+P • 7 more women with CHD • 8 more women with stroke • 8 more women with PE • 8 more women with breast cancer • Risk reduction per 10,000 person-years on E+P • 6 fewer colorectal cancer • 5 fewer hip fractures • Summary: 19 additional monitored events per 10,000 person years on E+P

  10. WHI CORONARY HEART DISEASE

  11. Coronary Heart Disease

  12. WHI FRACTURES

  13. WHI COLORECTAL CANCER

  14. Characteristics of Colorectal Cancer, by Treatment Group

  15. WHI DEMENTIA

  16. WHIMS – Neurological Evaluation PhaseTests • Modified Mini Mental State Exam • Expanded Neuropsychological Battery Interviews Geriatric Depression Scale Questions – Participant, Informant • Physical Exams - by Specialist Clarify – Mental State • Laboratory Tests 1. CT – Brain Without Contrast 2. Blood Tests WHIMS – JAMA 289:2651, 2003

  17. WHI BREAST CANCER

  18. Characteristics of Invasive Breast Cancer by Treatment Group

  19. Mammogram FindingsTreatment Group BaselineMost Severe Dx E & P Placebo E & P Placebo Negative 4125 4118 1359 1631 Benign 2807 2810 4294 4590 Abnormal 384 363 2601* 1677 *P < .001 WHI JAMA 289:2673, 2003.

  20. WHI GYNECOLOGICAL CANCER

  21. Gynecological Cancer Type E & P Placebo HR (95% CI) Ovarian 20 12 1.58 (0.77-3.24) Endometrial 27 31 0.81 (0.48-1.36) Cervix 8 5 1.44 (0.47-4.42) WHI JAMA 290:1739, 2003

  22. Endometrial Surveillance E & P Placebo P Endometrial Biopsy 2569 439 < .001 Multiple Biopsies 979 72 < .001 Ultrasound (US) 1089 331 < .001 Multiple US 299 60 < .001 WHI JAMA 290:1739, 2003

  23. NATIONAL PHARMACEUTICAL SALES

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