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Menopausal Hormone Replacement

Menopausal Hormone Replacement. Professor Gordana Prelevic, MD, DSc, FRCP Consultant Endocrinologist Royal Free Hampstead NHS Trust Whittington Health. Vasomotor symptoms. Hot flushes Sweats Occur in 74% of women Last 5 or more years in 25% 94 % menopausal symptoms

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Menopausal Hormone Replacement

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  1. Menopausal Hormone Replacement Professor Gordana Prelevic, MD, DSc, FRCP Consultant Endocrinologist Royal Free Hampstead NHS Trust Whittington Health

  2. Vasomotor symptoms • Hot flushes • Sweats Occur in 74% of women Last 5 or more years in 25% 94 % menopausal symptoms 64 % severe symptoms 3rd European Menopause Survey 2005

  3. Types of menopausal therapy Conventional HRT • Oestrogen oral, transdermal, implant • Oestrogen/progestogen sequential or continuous combined Steroid with tissue specific activity • Tibolone

  4. HRT - doses • Oestrogen • dose • symptoms • bone protection (+/- Ca++) • Progestogen • dose (sequential/continuous combined) • duration

  5. HRT - follow up • Symptoms • Bone mineral density • Pelvic US • mammography

  6. Women’s Health Initiative - WHI Randomized controlled primary prevention trial of 16608 postmenopausal women aged 50-79 with uterus in situ CEO 0.625 mg + MPA 2.5 mg Results: RR CI • CHD 1.29 0.85 - 1.97 • Stroke 1.41 0.86 - 2.31 • Breast cancer 1.26 0.83 - 1.92 • PE 2.13 1.26 - 3.55 • Colorectal cancer 0.63 0.32 - 1.24 • Hip fracture 0.66 0.33 - 1.33 JAMA 2002;288:321-333

  7. WHI - estrogen alone Randomized controlled primary prevention trial of 10739 postmenopausal women aged 50-79years with prior hysterectomy CEO 0.625 mg Results: RR CI • CHD 0.91 (0.75 - 1.12) • Stroke 1.39 (1.10 - 1.77) • Breast cancer 0.77 (0.59 - 1.01) • PE 1.34 (0.87 - 2.06) • Colorectal cancer 1.08 (0.75 - 1.55) • Hip fracture 0.61 (0.41 - 0.91) JAMA 2004;291:1707-1712

  8. Menopausal symptoms and quality of life • Estrogen therapy is gold standard treatment for hot flushes (effectiveness 90%) • 42% of women restarted HRT because of the return of symptoms (3rd European Menopause Survey 2005) • Effective doses (0.3 mg CEE, 0.5 mg E2 25mcg transdermal E2) • Only women with flushes have improvement in emotional measures of quality of life (JAMA 2002;287:591-597)

  9. Breast cancer risk & HRT Population based case control study 975 women with invasive Breast Ca 65-79 yrs & 1007 population controls ERT alone - no increased risk CHRT - 1.7-fold increased risk 2.7-fold increased risk of invasive lobular Ca Relation of HRT to risk of invasive Breast Ca by receptor status ER+/PR+ ER+/PR- ER-/PR- E alone 1.0 (0.8-1.4) 0.7(0.4-1.3) 1.0(0.5-1.9) CHRT 2.3(1.6-3.2) 1.4(0.8-2.4) 1.1(0.5-2.2) Li et al JAMA 2003;289:3254-3263

  10. Clinical profile of tibolone • Relief of climacteric symptoms restores vaginal atrophy beneficial effects on libido and mood • No endometrial stimulation • Prevention of osteoporosis & fractures • Risk of stroke similar to HRT • Non-estrogenic effect on breast tissue Less breast tenderness than with conventional HRTNo increase in mammographic breast density

  11. Mammograms beforeand after treatment with tibolone Woman receivingtransdermal E2/NETA Same woman 1 year afterchanging therapy to Livial Valdivia and Ortega 1997

  12. Risk of VTE with HRT • Risk in current users is 3-4 x higher than in non-users • one case in 5000 users per year • The baseline risk of VTE between the ages of 50 and 70 is higher • Increased risk appears to be concentrated in new users • VTE risk is not increased with transdermal E (oral 3.5 vs TRD 0.9) ESTHER study - Lancet 2003;362:428-432

  13. HRT & stroke • Risk increased for 39% (CEE alone) - 41% (CEE/MPA) • 29% increased risk in a meta-analysis (BMJ 2005;330:342-345) • ischaemic stroke • risk is cumulative • important factor increasing age Low dose TRDE2 no significant risk of stroke

  14. HRT - Cognitive function & Alzheimer’s Disease prevention • E may improve cognitive performance in recently menopausal women with menopausal symptoms (JAMA 2001;285:1489-1499) • WHIMS - women taking either CEE alone or CEE/MPA had higher risk of dementia (JAMA 2003;289:2651) • Negative impact on cognitive abilities when starting HRT after 65years and with existing cognitive problems (JAMA; 2004;291:2959-2968) • E in the treatment of AD - no benefit (Neurology 2000;54:295)

  15. HRT in women - who should get what? • Who ? Women with menopausal symptoms • When ? At the time of menopause / perimenopause • What ? Minimal dose which controls symptoms (0.5mg oral, 25mcg TRD) Transdermal estradiol (obesity, DM, Hypertension, Liver disease) Estrogen alone (Mirena IUS) Vaginal estriol Tibolone Type of progestogen ? • How long ? 3 - 5 years post-menopausal

  16. Key points (1) • Primary use of any form of HRT is to control menopausal symptoms • HRT should only be prescribed for the short-term relief of menopausal symptoms and prevention of osteoporosis • HRT should not be prescribed in the hope or expectation of any protection against arterial CVD or Alzheimer’s disease • Oral and non-oral oestrogen have different metabolic profiles that may impact on side-effects and therapeutic risks (VTE risk)

  17. Key points (2) • Combined E/PRG preparations have different profiles compared to E alone (lipids, CHD) • An increase in breast cancer risk is related to the duration of use and also concurrent use of progestogens. The role of E and/or PRG dose is unclear • Tibolone has significantly smaller risk of Breast Cancer compared to E/PRG preparations Data on HRT associated risks should not be extrapolated to women with premature menopause

  18. Appropriate & effective doses and regimens need to be individualized HRT should be part of overall strategy • life style • increase exercise • decrease alcohol intake • decrease smoking • fight obesity

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