Postmenopausal Hormone Therapy, SERMs and Breast Cancer绝经后激素治疗雌激素与乳腺癌.pptVIP

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Postmenopausal Hormone Therapy, SERMs and Breast Cancer绝经后激素治疗雌激素与乳腺癌.ppt

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Postmenopausal Hormone Therapy, SERMs and Breast Cancer绝经后激素治疗雌激素与乳腺癌

New Data on Ultra Low-Dose Estradiol Therapy in Osteoporosis Prevention Marie Foegh, MD, DSc VP, Medical Affairs Berlex Laboratories Outline Background Study Design Efficacy Safety Conclusion Loss of Estrogen has Profound Effects on Bone Increased resorption Rapid bone loss Apoptosis of osteocytes Increased risk of hip spine fracture Lowest effective dose“for the individual patient” Risk / Benefit Quality of Life Ultra Low Dose TransdermalEstrogen Replacement Assessment (ULTRA) UCSF Coordinating Center Deborah Grady, Steven Cummings, Eric Vittinghoff, Judy Macer, Judy Quan, Lorie Denton Investigators B. Ettinger (Kaiser Permanente), K. Ensrud (University of Minnesota), B. Wallace (University of Iowa), K. Johnson (University of Tennessee), P. Marx (Chicago Center for Clinical Research), S. Barbier (Seattle Women’s Clinical Research Center), J. Pinkerton (University of Virginia), M. Farmer (Meridien Research) and D. Rowe (Palm Beach Research Center) Design Randomized, placebo-controlled, blinded trial 417 women (E2 n=208, placebo n=209) 60 to 80 years old with an intact uterus More than 5 years post-menopausal BMD z-score ? - 2.0 Weekly transdermal E2 (0.014 mg/d) vs. placebo Goal to increase serum E2 to 10–15 pg/mL Daily calcium (800mg/d) and vitamin D (400 IU/d) Duration of Study: 2 years Follow-up visits every 4 months Effects of 0.014 mg E2 on BMD Effects of 0.014 mg E2 on BMD Patients with Clinical Fractures Pooling Both “Ultra Low” TrialsClinical Fractures Adverse Events: Serious Ultra Trial Conclusion Two years of unopposed ultra low dose transdermal estradiol Prevents bone loss in older post-menopausal women Safe for the endometrium Decrease in markers of bone turnover No increase in breast tenderness, headache and other common estrogen-related adverse events No effect on C-RP, SHBG, Lipids Paradigm Shift:Changing the Risk/Benefit Profile Ultra low dose estradiol: Fracture reduction in osteopenic patients Ultra low dose unopposed safe for the en