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WHI Overview of Principal Results

WHI Overview of Principal Results. Vanessa M. Barnabei, MD, PhD Medical College of Wisconsin Obstetrics and Gynecology. Cardiovascular Disease. Venous Thromboembolism. Breast Cancer. Fracture. Quality of Life. Symptom Relief: Effects of E+P. In women symptomatic at baseline:

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WHI Overview of Principal Results

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  1. WHI Overview of Principal Results Vanessa M. Barnabei, MD, PhD Medical College of Wisconsin Obstetrics and Gynecology

  2. Cardiovascular Disease

  3. Venous Thromboembolism

  4. Breast Cancer

  5. Fracture

  6. Quality of Life

  7. Symptom Relief: Effects of E+P • In women symptomatic at baseline: • Improvement in: • Hot flashes • Night sweats • Vaginal dryness • Joint pain/stiffness • General aches and pains • Younger, thinner women got the most relief from vasomotor symptoms

  8. Side Effects of E+P • In women asymptomatic at baseline: • Worsening of: • Breast tenderness • Vaginal discharge • Vaginal irritation • Headache • Older, thinner women more likely to develop breast tenderness

  9. Protective Effects of E+P • In women asymptomatic at baseline: • Protection from: • Hot flashes/night sweats • Vaginal dryness • Joint pain/stiffness • General aches and pains • Lower back pain • Neck pain • Protective effect on joint symptoms seen in all age groups

  10. Bleeding: Effects of E+P • E+P: • At 6 weeks: 42.5% • At 6 months: 54.0% • At 5 years: 13.1% • Women who were older, further from LMP, thinner and never/past HRT users were more likely to report bleeding

  11. Summary: Symptoms (E+P) • Vasomotor symptoms common in younger postmenopausal women • Musculoskeletal symptoms very common in all age groups • E+P relieved and prevented vasomotor and musculoskeletal symptoms • Women most likely to benefit from E+P are younger, symptomatic women

  12. WHI E+P and E-Alone Trials: Absolute (annualized) Risk Benefits Risks Risk Benefit Risk? Benefit?

  13. WHI Publications • Almost 400 manuscripts published or in various stages of preparation through Publications committee • Over 200 ancillary studies approved, most with outside funding • Large database available with demographic, reproductive, health information

  14. Biomarkers • Many ancillary studies utilize blood, serum, and DNA available through WHI • Available analytes include: • Hormones and receptors • Growth factors and receptors • Lipids • Vitamins, etc. • DNA such as CYP, MTHFR, TNF

  15. Ancillary Studies-Examples • “Hormones and biomarkers predicting stroke in women” (OS) • “Biochemical and genetic determinants of fracture in postmenopausal women” (OS) • “Decision-making about cancer screening among older women” (HT-CT) • “Prevalence and natural history of autoimmune thyroid disease in postmenopausal women” (OS)

  16. Ancillary Studies • Complete list of studies, biomarkers available from WHI investigators • WHI investigator must be a co-investigator • All proposals for ancillary studies must be approved by Publications and Proposals Committee of WHI

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