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Update on Managing Menopausal Symptoms

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Update on Managing Menopausal Symptoms Update on Managing Disclosures Menopausal Symptoms Dr. Meckstroth receives an honorarium from Danco, Inc. to serve as an expert for an FDA‐ mandated hotline for clinicians with questions regarding medical abortion. Karen R. Meckstroth, MD, MPH Director, UCSF Women’s Options Center Clinical Professor, UCSF Dept. of Obstetrics, Gynecology & Reproductive Sciences Zuckerberg San Francisco General Acknowledgements to Michael Policar, MD & Risa Kagan, MD Guidelines & Developments in Stages of Reproductive Aging Workshop Menopause Management (STRAW) Nomenclature and criteria in reproductive aging FMP • 2012 STRAW +10 Reproductive phase Menopausal Post‐ Symptom management Transition Menopause • 2014 (2016) ACOG Pract Bulletin Mgt of Menopausal Sx AMH, 1 inhibin B • 2017 + earlier NAMS Position Statements – June 20th Y decline in R GSM late repro Perimenopause • 2014 ISSWSH‐NAMS Consensus Statement • 2015 Petition to remove black box < 40: Primary ovarian insufficiency (1%) 40‐45 yo or surgical: Early Menopause (5%) FSH IU/L Consequences of Estrogen Loss • Vasomotor symptoms hot flashes, night sweats • Neuro‐behavioral sleep problems, memory loss • Genitourinary Syndrome of Menopause (GSM) – Vaginal dryness, painful sex E2 pg/mL – Burning on urination; urge incontinence • Bone loss increased hip, vertebral fracture risk • Increased risk of MI, stroke (vs. premenopause) Figure 1 Adjusted population means (95% CI) for segmented mean profiles of follicle-stimulating hormone and estradiol across the final menstrual period in the Study of Women's Health Across the Nation (n =1,215). *, The y axis is unitless. The units of hormone are marked in the corresponding curves. Reproduced with permission from Randolph et al., J Clin Endocrinol Metab 2011;96:746–754 Published in: Siobán D. Harlow; Margery Gass; Janet E. Hall; Roger Lobo; Pauline Maki; Robert W. Rebar; Sherry Sherman; Patrick M. Sluss; Tobie J. de Villiers; Climacteric 2012, 15, 105-114.DOI: 10.3109/13697137.2011.650656 Copyright © 2012 International Menopause Society Vasomotor Symptoms (VMS) Duration of Menopausal VMS • Experienced by 75% of menopausal women • 3302 women 7 US sites; 1996‐ 2013, median 13 visits – May start during the peri‐menopause • Findings: – Cluster in 2‐year window before and after FMP – Duration 7.4 yrs (median) – 25% have hot flushes > 5 years after menopause – Persistence post‐FMP 4.5 yrs (median) • Smoking and obesity are risk factors – Both longer if premenopausal or early perimenopausal • Ethnic and racial differences when first reported frequent VMS Duration 11.8 yrs – More common in African‐American women Persistence post‐FMP 9.4 yrs – Less common in Chinese, Japanese FMP: final menstrual period Avis NE, et. al, for SWAN. JAMA Int Med. 2015 2017 NAMS Hormone Therapy Moderate‐Severe Hot Flashes CI: Contra‐ Position Statement (inadequate response to lifestyle modifications) Indication HT: Hormone therapy • Benefit‐risk ratio appears favorable for vasomotor No Yes symptoms (VMS) and elevated risk of bone loss or fracture if starting treatment: GSM sxs? Wants HT? No CI? – Younger than 60yo Yes No Yes No – Within 10 yrs of menopause Yrs since MP CV risk* <5Y 6‐10Y >10Y Wants SSRI? No CI? – No contraindications Free of Br/em ca? Avoid HT Low (5%) HT OK HT OK Avoid Mod (5‐10%) HT OK* HT OK* Avoid • Risks for above groups: CHD, stroke, DVT, dementia High (>10%) Avoid Avoid Avoid Yes No • Do NOT need to routinely D/C at any age Yes No •Prior hyst: E alone Try Try Try vaginal E or Intimate lubricants 2 2 •Intact uterus: E+P or • SSRI • GBP • Longer duration more favorable for estrogen alone ospemifene + moisturizers CEE + bazedoxifene • SNRI • Others * Consider transdermal hormone therapy Manson JE, Menopause 2015;22:247‐53 * CVriskcalculator.com In addition to sleep hygiene and stimulus control, Case Study Would you recommend….. • Ms S is a 53 year old woman with moderate‐severe hot flashes and difficulty getting to sleep 1. a sleep/insomnia medication • Her menses were regular until two years ago, 2. a trial of SSRI or SNRI medication became irregular, and then stopped 16 months ago 3. lowest dose of estrogen and progestin • She has tried a number of herbal remedies, each of 4. a “mid‐range” dose of estrogen and progestin which helped for only a few months • Her medical history, BP, physical exam are normal 5. a consultation visit with an ObGyn • The hot flashes affect her work productivity and she wants to try something else Explaining HT Benefit and Risk Contraindications for Systemic HT HT risk is related to • Unexplained vaginal bleeding • A woman’s baseline disease risks • Severe active liver disease • Her age • Prior estrogen‐sensitive breast or endometrial ca • Age at menopause • CVD, stroke • Cause of menopause • Dementia • Time since menopause • History of or high risk for thromboembolic disease • • Prior use of any hormone Hypertriglyceridemia • HT types, route of administration, doses used Concerns: endometriosis or migraine may worsen, • Emerging medical conditions during treatment fibroids may grow NAMS position statements. Menopause 2008, 2012, 2017. Systemic HT & CV Risk (and All‐Cause Mortality) Systemic HT & Breast Cancer • Initiation <10 yrs after menopause and < 60yo • Effect of HT on breast cancer risk depends on – CVD lower and reduction in all‐cause mortality – Type of HT, regimen, dose, duration and route – Prior exposure and individual characteristics – Likely no increased risk of stroke • Nonsignificant reduction in risk w CEE alone – Increased risk VTE (RR=1.74) (in RCTs but not all obs studies. 7 fewer in 10,000) • Initiation > 10yrs or over 60yo • Increased risk with CEE+MPA. <1 more in 1000 – Increased stroke (RR=1.21) and VTE (RR=1.96) (in some RCTs and many obs studies) • Fewer breast changes w CEE+bazedoxifene • Across all ages: Stroke ↑6 per 10K, VTE ↑8 per 10K • Survivors: systemic generally not recommended; • Transdermal estrogen: lower risk in obs studies Local “may be considered” if fails non‐hormonal tx NAMS 2017 NAMS 2017 Nonhormonal Management of Menopause‐associated VMS Recommend: Nonhormonal Management of Menopause‐associated Cognitive‐behavioral therapy (insomnia > hot flashes) Vasomotor Symptoms (VMS) Prescription Therapies • FDA‐approved low‐dose paroxetine salt (the only FDA‐approved non‐hormonal Rx) Key points from the • Gabapentin and pregabalin 2015 NAMS Position Statement • Other SSRIs and SNRIs yielding significant VMS reductions in large RCTs NAMS. Menopause. 2015 VMS: Non‐Hormonal Therapies Recommend With Caution Level II evidence suggests these may be beneficial % treated patients % placebo patients • Weight loss with >50% ↓HF with >50% ↓HF • Mindfulness‐based stress reduction Venlafaxine 75 mg 54‐70% 30% (ok on tamoxifen) • S‐equol derivative of soy Paroxitine 10mg 50‐76% 35‐57% • Stellate ganglion block (SGB) Sertraline (Zoloft) 40‐56% 21‐41% (non signif) – Image‐guided anesthetic block at C‐6 level Escitalopram 55% 36% Gabapentin 46‐84% 27‐47% – 45‐90% HF reduction for 6 weeks‐3 months – No significant HF reduction at 6 months Nelson. JAMA 2006; J Clinical Oncology 2009 NAMS. Menopause. 2015 © 2015 Do Not Recommend at This Time (No benefit or no studies) Do Not Recommend • Over‐the‐counter supplements Level I evidence shows these are unlikely to • Herbal therapies alleviate VMS; may have other health benefits • Vitamins • Exercise • Relaxation • Yoga • Calibration of neural oscillations • Paced respiration • Chiropractic intervention • Acupuncture • Cooling techniques • Avoiding “triggers” NAMS Menopause. 2015. © 2015 NAMS Recommendations For Clinical Care of Midlife Women Prescription HT Options: ET and EPT • Hormone therapy is the most effective treatment for Oral Transdermal Intravaginal vasomotor symptoms ET • Micronized estradiol • Patches • Creams • “The benefits outweigh the risks for most healthy, • Conjugated equine • Gels • Intravaginal symptomatic women aged younger than 60 years or estrogens (CEE) • Emulsion tablet within 10 years of the final menstrual period” • Synthetic conjugated • Spray • Rings • Options include: estrogens – Estrogen alone (no uterus) • Esterified estrogens – Estrogen‐progestogen • Estropipate – Estrogen‐bazedoxifene • Estradiol acetate – Progestogen alone (300mg MP qhs, DMPA) EPT • CC‐EPT • E+P combo patch – Combined OCs in women requiring contraception • CS‐EPT NAMS. Menopause 2014, 2017 Hormone Therapy Regimens Choice of HT Regimen Month 1Month 2 Estrogen Therapy (ET) • If no uterus: estrogen only Estrogen • If uterus present: estrogen + progestogen Continuous combined (CC) EPT – Goal is to avoid vaginal bleeding entirely, or, at Estrogen least, to make it predictable Progestin • Endometrial activity predicts bleeding pattern Continuous‐sequential (CS) EPT Estrogen – Recent spontaneous or induced bleeding: Progestin 14d Off for 14 dOff for 14 d • Use continuous sequential Continuous‐pulsed (CP) EPT – No bleeding for >2‐3 cycles: 3d • Use continuous combined Hormone Therapy Dosages Choice of Estrogens “Appropriate, often lowest” appropriate • Start low dose transdermal or oral estrogen • The lowest dose of HT should be used for the shortest • If suboptimal response, modify by: duration needed to manage menopausal symptoms – Change the estrogen dose (upward) • Lower doses better tolerated, may have more – Change the estrogen preparation favorable benefit‐risk ratio than standard doses – Change delivery systems (oral transdermal) • Additional local ET may be needed for persistent – Consider an estrogen + androgen (Covaryx)* vaginal symptoms • Injectable estrogen
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