1 / 29

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

cooper-savage
Download Presentation

WHI Estrogen+Progestin Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related