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Menopause and Hormone Therapy

Menopause and Hormone Therapy. Jennifer O. Howell, MD Women’s Primary Healthcare Division UNC OB/GYN. Objectives. evaluate and treat menopause/perimenopausal conditions, including the use of lifestyle modifications and hormone replacement therapy

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Menopause and Hormone Therapy

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  1. Menopause and Hormone Therapy Jennifer O. Howell, MD Women’s Primary Healthcare Division UNC OB/GYN

  2. Objectives • evaluate and treat menopause/perimenopausal conditions, including the use of lifestyle modifications and hormone replacement therapy • identify and screen patients at risk for osteoporosis • review calcium/Vitamin D supplementation for prevention of fractures in postmenopausal women • describe long-term follow-up necessary for menopausal patients • describe indications/contraindications for treating patients with HT

  3. Menopause • Definition: 12 months of amenorrhea; average age is 51 • Perimenopause – “around the menopause” – later part of the menopausal transition  first 5 yrs after menopause • Menopausal transition • Variable cycle length - early • Skipped menses - later • Vasomotor symptoms -later

  4. Menopausal health issues Well-woman exam in a 57 yo – sees internist only when sick • Osteoporosis screening • Mammography – ACOG 2011: yearly from 40 on • Cardiovascular risk factor assessment • Colon cancer screening – Colonoscopy q 10yrs @ age 50 • Thyroid screening – can consider age >50 • Vaccines (flu qyr;Td q10yrs; pneumococcus 1x age>65) • Depression screening

  5. Osteoporosis • Prevention • Calcium – diet and supplement = 1200mg/day • Vitamin D – 800 IU • Weight-bearing exercise • Screening – DEXA scans Age >65, consider for patients between 50-65 if RF: • Long-term Glucocorticoid therapy • Low body weight (<127lbs) • FH of hip fracture • Cigarette smoking • Excess alcohol intake • How often to screen?

  6. DEXA scans – quick tutorial • Dual energy xrayabsorptiometry • Measures bone mineral content in grams ÷ bone area = Bone mineral density (BMD – g/cm2) • Typically measures Hip and Lumbar spine BMD • T-score = patient’s BMD – mean value of young-adult reference population ÷ SD of YA population • This value used to diagnose osteoporosis in peri/post menopausal women • Z-score compares patients BMD to a population of peers • This value for premenopausal patients

  7. T score = -1.0 – -2.4 T-score ≤ -2.5

  8. Osteoporosis – the FRAX tool • NOF (national osteoporosis foundation) recommends tx of postmenopausal women w/ H/O vertebral/hip fracture or with Osteoporosis based on T-score. • What about Osteopenic patients? Use the FRAX tool • Uses BMD at the hip, FH, age, BMI, habits, ethnicity, country to calculate 10yr fracture risk • Consider tx for patients whose 10 yr risk of major osteoporotic fracture exceeds 20% • http://www.shef.ac.uk/FRAX/index.jsp

  9. Pharmacologic Tx - osteoporosis • R/O secondary osteoporosis, especially in young patients • Labs – Ca, Phosphorous, Cr, CBC, 25-hydroxy Vit D • Cancer, multiple myeloma, hyperparathyroidism Bisphosphonates - Inhibit bone resorption • Aledronate (Fosomax) 70mg weekly same fx • Risedronate (Actonel) 35mg weekly data • Ibandronate (Boniva) 150mg monthly (no hip fx data) • IV Zoledronic Acid (Reclast) yearly

  10. BisphosphonatesWhat else do I need to know? • Contraindications – Upper GI disease, renal insufficiency • How to take? Empty stomach, first thing in am, 80z water, no food or drink and stay upright for 30min & make sure getting adequate Ca & Vit D • “I saw on the news . . .̋ • ONJ – 1/10,000-1/100,000; mostly on IV therapy, cancer, dental work, poor dentition • Musculoskeletal pain, Afib, long-term use and atypical fx • Check response to therapy ~2yrs repeat DEXA; consider “drug holiday” after 5 years.

  11. Raloxifene (Evista) • SERM – 60mg/daily, oral • Strong agonist at the bone • Strong antagonist at the Breast • No effect on endometruim • Usually worsens vasomotor sx • Same VTE risk as Estrogen • Reasonable alternative to Bisphos. in intolerant patients • Good prevention indication; not as good treatment option in terms of BMD/fracture data • Consider in pts with FH Breast CA

  12. Menopausal Sx • Bleeding patterns • Hot flushes • Sleep disturbance • Vaginal dryness • Sexual dysfunction • Irritative urinary sx • Depression/anxiety • Breast pain • Menstrual migraines • Joint pain/skin changes

  13. Treatmentof Menopausal Sx • Over the counter options • Non Hormonal pharmacological options • Hormone therapy

  14. Herbal Remedies for Vasomotor Sx - phytoestrogens Isoflavones • Soy: -double blind, crossover study in Br cancer pts – no effect; more pts preferred placebo -meta-analysis of 11 studies – negative results • Red Clover: (promensil) -meta-analysis of 6 trials – all negative results Lignans • Flaxseed -several trials, small numbers; trend toward reduction in hot flashes -double-blind, placebo-controlled RCT presented in 2011 – No effect

  15. Herbal remedies for Vasomotor Sx • Black Cohosh–no effect in RCT and safety concerns • Vitamin E- weak results in RCT, and patients did not prefer in cross-over studies • DHEA- positive results in 2 small trials, not confirmed with RCT • Evening Primrose Oil- no effect in RCT • Dong Quai-no effect in RCT, estrogen-like effect so safety concern in breast cancer patients • Ginseng-no effect in RCT • Wild Yam – no effect in RCT& progestational

  16. Non-Hormonal Options –Vasomotor sx *results only on crossover arm (Bordeleau, Clinical Therapeutics/Vol 29, #2, 2007)

  17. Treatment - HT • Contraindications: known CHD, breast cancer, previous thromboembolic event or CVA, active liver disease • HERS data (1998) – RCT, Prempro, av. age 67, did not prevent heart disease; increase VTE • WHI data (2002) RCT, halted early – Prempro; average age 65; extra 8 cases per 10,000 w.yrs of MI & breast cancer; increased VTE risk, decreased risk of colon cancer, osteoporotic fractures; estrogen –only arm?

  18. ACOG’s thoughts . . . • HT is effective and FDA-approved for the relief of menopausal symptoms such as hot flashes. • Although HT is effective for prevention of postmenopausal osteoporosis, consider non-estrogen medications first if osteoporosis prevention is the sole reason for using HT. • HT should not be used for the prevention of heart disease. • Although the WHI study of HT used a specific prescription product [Prempro, estrogen plus progestin], absent further data it should not be assumed that the risks would be different for any other hormone therapies or products.

  19. NAMS position statement • HT is the most effective treatment for menopause related vasomotor symptoms = primary indication for HT • Lowest effective doses • Limited to transition years • Full discussion of R&B especially if considering long-term use

  20. Hormone Therapy • 49yo P2 LMP: 2 months ago c/o intermittent hot flushes, vaginal dryness, emotional lability and severe PMS in the setting of extreme cycle variability q21-60 days. • BMI 22, normal exam except mild loss of rugations on speculum exam • mild HTN on HCTZ; on Zoloft for years for dysthymia; FH positive for MI and DM in mother age 65, postmenopausal breast cancer in MGM • married; 2 teenagers; wine @ night, non-smoker

  21. What to do? • Low-dose OCP’s • HT • Combined cyclic – estrogen every day and progestin x 14 days of month (peri or early menopausal; +withdrawal bleed) • Combined continuous – E&Pevery day (later postmenopausal, possible BTB 3-6months) Consider baseline endometrial biopsy and/or if BTB persists

  22. Types of Estrogens • Oral vs. Transdermal – ?less VTE with transdermal • Equivalents: 1mg of estradiol = 50mcg/day of estradiol patch=0.625mg conjugated EE(Premarin)=0.75mg esterified estrogen (Ogen)=5mcg ethinylestradiol Tips: “Low dose” E2 – 0.3-0.5mg (.025mcg/d patch) may be sufficient Unopposed estrogen can often be useful especially premenstrually in perimenop. woman; short term only as a “test dose” Treat vaginal atrophy only with local vs. systemic estrogen.

  23. Vaginal Estrogens – dosing & absorption • Estradiol tablet (Vagifem) • 10 mcg - 3 to 11 pg/mL serum estradiol • Low dose estradiol ring (Estring) • 7.5 mcg/day - 5 to 10 pg/mL serum estradiol • Conjugated estrogens cream (Premarin) • 1 g of cream = 0.625 mg conjugated estrogens • Estradiol cream (Estrace) • 1 g of cream = 100 mcg estradiol; 200 mcg of estradiol cream results in a serum estradiol level of approximately 40 pg/mL

  24. Vaginal Estrogens - Regimens • Estradiol ring (Estring) – q 3months • Estradiol tablets – qhsx2weeks, then 2-3x/week • Creams – long term you want no more than 50mcg estradiol; o.3conjugated estrogens = ½ gram cream. • 1g (1/2 applicator full) qhs x2 weeks, ½ -1g q2-3nights week • Applicators are often 2g applicators so many people write prescriptions based on this; confusing, safer to specify grams. • Not necessary for routine P4 withdrawal; can consider qyr as a test.

  25. Types of Progestin • Mostly oral (with few exceptions) • MPA 5-10mg day=cyclic dosing; 2.5mg combined • Micronized progesterone (Prometrium) 200mg cyclic; 100-200mg combined • Norithindrone (Aygestin) 5mg cyclic, .5-1mg combined • Drospiredone Alternate progestin regimens – quarterly, Levonorgestrel IUD – data lacking; but an option with disclosure to patients and +/- endometrial sampling.

  26. Products (I have no conflict of interest ) Combined products – Oral: Prempro – CEE/MPA (several different doses .625/2.5; .625/5; .45/1.25, .3/1.5) FemHRT -5mcg ethinyl estradiol/1mg norithindrone (2.5/0.5) Prefest- 1mg estradiol/0.9 norgestimate Activella – 1mg estradiol/0.5mg norithindrone Angelique – 1mg estrdiol/0.5mg drospirenone Transdermal: ClimaraPro - .045mcg E/.015 levonorg., Combipatch.05/1.25norethindrone

  27. Products (I have no conflict of interest ) • Systemic Estrogens • Patches all estradiol in varying doses – (Climara, Vivelle, generic); Menostar - .014mcg approved for prevention of osteoporosis, twice yrly P4 – not well-studied; works for hot flushes in some women • Oral – CEE, CSE, estradiol, esterified estrogens • Vaginal – FemRing (50 or 100mcg estradiol q 3months) • Emulsions, Gels, Sprays: (Estrasorb; Divigel, Estrogel, Elestrin; Evamyst) – watch for unintentional exposure in kids and pets

  28. Others Estrogen & Testosterone combinations (Estratest, generic) • 1.25mg estrogen/2.5 methyltestosterone or HS version (half-stregnth) 0.625/1.25 Bio-identical Hormone replacement – What is this?

  29. The End! Questions?

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