James H. Liu, M.D. Arthur H. Bill Professor Chair of Reproductive Biology Dept of Obstetrics and Gynecology

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1 Disclosure Estrogen Therapy After Postmenopausal Hysterectomy: Issues, Challenges, Risks/Benefits James H. Liu, M.D. Arthur H. Bill Professor Chair of Reproductive Biology Dept of Obstetrics and Gynecology Advisory Boards Pfizer Actavis Charter Venture Sermonix Nuelle Clinical Trials AbbVie NIH Actavis Palatin Pharmacos Case Medical Center Case School of Medicine Case Research Institute University Hospitals UH Medical Group University Hospitals at Case Medical Center is the primary affiliate of Case Western Reserve University School of Medicine. Epidemiology Definitions Truth is ascertained only when sufficient numbers of appropriate studies are conducted and no one study or one study design has a monopoly on the truth. Hormone Therapy (HT) Use of an estrogen and progestin taken cyclically or in a combined E + P mode taken on a daily basis. Estrogen Therapy (ET) Use of an estrogen-only preparation daily Estrogen-Progestin Therapy (EPT) Use of estrogen and progestin therapy (cyclic and continuous combined) For the Women s Health Initiative, E+ P was used on a daily basis Trudy Bush Int. J. Fert. 2001:46:56 1

2 Is What We Know About Hormone Therapy a Delusion? HT Then and Now Key Findings of WHI-E Trial From WHI (E+P) Arm halted FDA Treatment Recommendations 2004 WHI (E) Arm ended Today Treat Menopausal Symptoms Lowest dose, shortest period of time to meet treatment goals Broadening therapy options Small decrease in breast cancer risk No change in cardiovascular risk Known DVT risk Increase risk of stroke Increase in urinary incontinence Reduce fractures So What Does this Elephant Look Like Now? 10/6/09 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 6 Issues: Causes of Death Among U.S. Women Issues: Extended WHI Trial Results and Now the Post Treatment Follow-up Other (25%) Heart Disease (45%) Not publicized Lack of interest by clinicians as old news Too new to percolate into practice guidelines and recommendations Pneumonia (4%) COPD (4%) Ovarian Cancer (<2%) Breast Cancer (4%) Lung Cancer (5%) Other Cancer (11%) 11/14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 8 2

3 From: Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy: A Randomized Controlled Trial From: Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy: A Randomized Controlled Trial JAMA. 2011;305(13): doi: /jama JAMA. 2011;305(13): doi: /jama Figure Legend: Figure Legend: Vertical dotted lines represent quintiles of duration of intended intervention and follow-up in the study population (elapsed time from randomization until the end of the intervention on February 29, 2004). CEE indicates conjugated equine estrogens.aincludes events from randomization to August 14, 2009.bIncludes events from March 1, 2004, to August 14, Vertical dotted lines represent quintiles of duration of intended intervention and follow-up in the study population (elapsed time from randomization until the end of the intervention on February 29, 2004). CEE indicates conjugated equine estrogens.aincludes events from randomization to August 14, 2009.bIncludes events from March 1, 2004, to August 14, Date of download: 9/22/2015 Copyright 2015 American Medical Association. All rights reserved. Date of download: 9/22/2015 From: Health Outcomes After Stopping Conjugated Equine Estrogens Among Postmenopausal Women With Prior Hysterectomy: A Randomized Controlled Trial Copyright 2015 American Medical Association. All rights reserved. The Timing Hypothesis for Cardiovascular Risk and Hormone Therapy: A Window of Opportunity (50-59yrs) Estrogen-Alone JAMA. 2011;305(13): doi: /jama CEE versus placebo had significant reductions in CHD (HR 0.59; ) CEE versus placebo had significant reductions in MI (HR 0.54; ) CEE versus placebo had significant reductions in overall mortality (HR 0.73; ) Figure Legend: Annualized incidence rates were estimated for the overall follow-up period by dividing the number of events by the corresponding person-time for participants in each age stratum. The black squares indicate the HRs for the overall followup period. For comparison, the HRs for the intervention phase are shown as blue bars. CEE indicates conjugated equine estrogen; CHD, coronary heart disease; CI, confidence interval; MI, myocardial infarction. Date of download: 9/22/2015 Copyright 2015 American Medical Association. All rights reserved. 11/14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 12 3

4 Challenges: Fear of Breast Cancer Issues: WHI CEE alone-breast Cancer Risk The fear of breast cancer is unlike any other health condition. Breast cancer is common, yet death from breast cancer is 4% among all other causes. Public is ill informed regarding breast cancer risks. Lancet Oncol 2012; 13: /14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 13 11/14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 14 Issues: WHI CEE alone-breast Cancer Deaths Challenges: Why Would Estrogen Inhibit Breast Cancer in This Age Group? Decrease in breast ca in CEE group runs counter to perceived notion of role of E in breast carcinogenesis. Did you know that high dose estrogen (DES) was used to treat metastatic breast ca in the s? Concept of estrogeninduced apoptosis. Lancet Oncol 2012; 13: /14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 15 acancer Prev Res 2011: 4(5): /14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 16 4

5 Challenges: Counseling Breast Cancer Risk and Hormone Therapy: Overall Perspective Challenges: Recurrence of Endometriosis with Estrogen Therapy Relative Risk Over 100,000 hysterectomies are performed for endometriosis. Use of hormone therapy is associated with recurrence of pelvic pain in 3.5% of cases. Malignant transformation of residual endometriosis foci into endometriod cancer is rare. 0 Increase Breast Density High Serum E2 Obesity E+P E alone Climacteric 2012;15: /14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 17 Facts Views Vis ObGyn 2014; 6(4): /14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 18 Issues: Estrogen Dosing Options Local Vaginal Estrogen Vagifem Premarin cream Estrace cream Estring High Systemic Dose E 50 μg per day E2 Transdermal mg CEE, E 1 SO 4, esterified E Low Systemic Dose E 14 μg, 25 µg, 37.5 µg per day E2 Transdermal 1.0 mg oral E2 0.3 mg, 0.45 mg CEE, E 1 SO 4, esterified E ET and VTE* in French Menopausal Women ESTHER Study: Case n = 259 Control n = 603 OR 95% CI None 1 Oral ET Transdermal ET Canonico M, et al. Circulation. 2007;115: VTE = venous thrombophilias. 5

6 Mean concentrations of E 1 and E 2 in plasma of postmenopausal women following administration of E 2 by the transdermal and oral route Adapted from Etaigle JW, Schenkel L. Estrogens and Progestogens. Churchill Livingston, London; Take Home Away Points For CHD (1 o endpoint), the HR was NULL in CEE vs Placebo during and postinterval HR for the 50-59yo group favored CEE For Breast CA (1 o endpoint), the CEE risk was LOWER during the treatment and postinterval Stroke risk is higher with CEE but the risks dissipated during the post-interval for CEE Rates of total mortality and the global index of chronic diseases were the same in both groups overall. 11/14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 22 Issues: NAMS Position Statement on Hormone Therapy in Older Women The decision to continue or discontinue HT should be made jointly by the woman and her healthcare provider that the woman has been advised of the increase in risks associated with continuing HT beyond age 60 and has clinical supervision, extending HT use with the lowest effective dose is acceptable under some circumstances, such as for the woman who has persistent bothersome menopausal symptoms and for whom her clinician has determined that the benefits of menopause symptom relief outweigh the risks. Use of HT should be individualized and not discontinued solely based on a woman age. The decision to continue or discontinue HT should be made jointly by the woman and her healthcare provider 11/14/06 University Hospitals Case Medical Center / Case Western Reserve University School of Medicine 23 6

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