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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 Vanessa M. Barnabei, MD, PhD Medical College of Wisconsin Obstetrics and Gynecology
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
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
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
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
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
WHI E+P and E-Alone Trials: Absolute (annualized) Risk Benefits Risks Risk Benefit Risk? Benefit?
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
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
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)
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