MENOPAUSAL HORMONE THERAPY 2016

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2 MENOPAUSAL HORMONE THERAPY 2016 Carolyn J. Crandall, MD, MS Professor of Medicine David Geffen School of Medicine at UCLA NICE provides the National Health Service advice on effective, good value healthcare. Rigor, independence, objectivity. Case 1. Woman aged 46 years with vasomotor symptoms and irregular periods, otherwise healthy. Case 2. Female aged 46 years with no menses for 13 months, not using hormonal contraception, otherwise healthy Diagnosis? Laboratory tests indicated? Diagnosis? Laboratory tests indicated? Case 3. Female aged 48 years with no uterus, having vasomotor symptoms, otherwise healthy DIAGNOSIS: WOMEN >45 YEARS-OLD Diagnosis? Laboratory tests indicated? Diagnose the following without laboratory tests in otherwise healthy women aged over 45 years with menopausal symptoms: perimenopause based on vasomotor symptoms and irregular periods menopause in women who have not had a period for at least 12 months and are not using hormonal contraception menopause based on symptoms in women without a uterus. (12 Nov National Collaborating Centre for Women s and

3 DIAGNOSIS: WOMEN > 45 YEARS-OLD DIAGNOSIS OF MENOPAUSE <AGE 45 YEARS Do not use estradiol to diagnose perimenopause or menopause in women aged over 45 years Consider using a FSH test to diagnose menopause only: in women aged 40 to 45 years with menopausal symptoms, including a change in their menstrual cycle in women aged under 40 years in whom menopause is suspected PREMATURE OVARIAN INSUFFICIENCY: DIAGNOSIS PREMATURE OVARIAN INSUFFICIENCY: THERAPY Diagnose premature ovarian insufficiency in women aged under 40 years based on: menopausal symptoms, including no or infrequent periods (taking into account whether the woman has a uterus) and elevated FSH levels on 2 blood samples taken 4 6 weeks apart. Explain: the importance of starting hormonal treatment either with HT or a combined hormonal contraceptive and continuing treatment until at least the age of natural menopause (unless contraindicated) that the baseline population risk of diseases such as breast cancer and cardiovascular disease increases with age and is very low in women aged under 40 (PREGNANCY TEST MAY BE APPROPRIATE, DON T FORGET) Case 4. Female aged 49 years using combined estrogen + progestogen contraception wants to know if she is menopausal Order folliclestimulating hormone (FSH) test? Order estradiol test?

4 DIAGNOSIS OF MENOPAUSE: CAREFUL THERAPY: INDIVIDUALIZED APPROACH Do not use a serum follicle-stimulating hormone (FSH) test to diagnose menopause in women using combined estrogen and progestogen contraception or high-dose progestogen. Offer women HT for vasomotor symptoms after discussing with them the short-term (up to 5 years) and longer-term benefits and risks. Offer a choice of preparations as follows: estrogen and progestogen to women with a uterus estrogen alone to women without a uterus. True or false: Serotonin and norepinephrine reuptake inhibitors (SNRIs) are as effective as estrogen therapy for relieving vasomotor symptoms. NON-ESTROGEN PRESCRIPTION DRUGS? Do not routinely offer selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) or clonidine as first-line treatment for vasomotor symptoms alone. False THE ONLY SSRI FDA-APPROVED TO TREAT VASOMOTOR SYMPTOMS Brisdelle-paroxetine mesylate capsule 7.5 mg once daily, at bedtime Indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause BIOIDENTICAL HORMONES? Explain to women that the efficacy and safety of unregulated compounded bioidentical hormones are unknown. Explain to women who wish to try complementary therapies that the quality, purity and constituents of products may be unknown.

5 UROGENITAL ATROPHY MONITOR UTERUS? Offer vaginal estrogen to women with urogenital atrophy as long as needed to relieve symptoms. symptoms often come back when treatment is stopped adverse effects from vaginal estrogen are very rare report unscheduled vaginal bleeding. Do not offer routine monitoring of endometrial thickness during treatment for urogenital atrophy. NON-ESTROGEN VAGINAL THERAPIES Advise women with vaginal dryness that moisturizers and lubricants can be used alone or in addition to vaginal estrogen. Case 5. Menopausal female aged 53 years started oral estrogen + to control vasomotor symptoms 8 weeks ago. Had intermittent vaginal spotting for a few days 4 weeks ago. Endometrial biopsy? UNSCHEDULED VAGINAL BLEEDING Unscheduled vaginal bleeding is a common side-effect of HT within the first 3 months of treatment but should be reported at the 3-month review appointment, or promptly if it occurs after the first 3 months Question: When you stop HT, is it better to wean?

6 WEANING HT? VENOUS THROMBOEMBOLISM Offer women who are stopping HT a choice of gradually reducing or immediately stopping treatment. gradually reducing HT may limit recurrence of symptoms in the short term gradually reducing or immediately stopping HT makes no difference to their symptoms in the longer term. Risk of venous thromboembolism (VTE) increased by oral HT compared with baseline population risk greater for oral than transdermal HT with transdermal HT at standard therapeutic doses is no greater than baseline population risk. Case 6. Female aged 49 years having bothersome vasomotor symptoms, healthy except body mass index 31 kg/m 2. What type of menopausal hormonal therapy should you recommend? OBESITY AND VENOUS THROMBOEMBOLISM Consider transdermal rather than oral HT for menopausal women who are at increased risk of VTE, including those with a BMI over 30 kg/m 2. Stroke and myocardial infarction Oral estrogen vs. oral estrogen + progestogen???? HT AND CARDIOVASCULAR DISEASE (CVD) The baseline risk of coronary heart disease and stroke for women around menopausal age varies from one woman to another according to cardiovascular risk factors HT: does not increase CVD risk when started in women aged under 60 years does not affect the risk of dying from CVD.

7 HT: CORONARY HEART DISEASE HT: STROKE HT with estrogen alone: associated with no, or reduced, risk of coronary heart disease HT with estrogen and progestogen: associated with little or no increase in the risk of coronary heart disease. (12 Nov National Collaborating Centre for Women s and Taking oral (but not transdermal) estrogen is associated with a small increase in the risk of stroke. The baseline population risk of stroke in women aged under 60 years is very low Breast cancer Oral estrogen Oral estrogen + progestogen stroke myocardial infarction Oral estrogen vs. oral estrogen +???? But, absolute increases in risk small. HT AND BREAST CANCER HT AND BREAST CANCER The baseline risk of breast cancer for women around menopausal age varies from one woman to another according to the presence of underlying risk factors HT with estrogen alone is associated with little or no change in the risk of breast cancer contd HT with estrogen and progestogen can be associated with an increase in the risk of breast cancer any increase in the risk of breast cancer is related to treatment duration and reduces after stopping HT.

8 AHRQ COMPARATIVE EFFECTIVENESS REVIEW 2015 Oral estrogen Oral estrogen + progestogen But, absolute increases in risk small. No increase in breast cancer risk breast cancer risk Agency for Healthcare Research and Quality Screened 9,727 records. Comparisons were made using the standardized mean difference, SMD: (Effect treatment-effect comparator)/standard deviation Allows comparison of results across trials using different measures. Pay attention to the strength of evidence column. VASOMOTOR SYMPTOMS Number of Comparators Comparisons 9 Estrogen (high) vs. plac. 39 Estrogen (standard) vs. plac. 53 Estrogen (low/ultralow) vs. plac. Effect Size (SMD) (95% CI) (-0.61 to -0.39) High (-0.74 to -0.53) High (-0.61 to -0.48) High 13 SSRI/SNRI vs. plac (-0.46 to -0.24) High CI = confidence interval; SMD = standardized mean difference; SNRI = serotonin-norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. VASOMOTOR SYMPTOMS, CONTD Number of Comparators Comparisons 5 Gabapentin vs. 35 Isoflavones vs. 4 Black cohosh vs. 3 Ginseng vs. Effect Size (SMD) (95% CI) (-0.38 to -0.19) Moderate (-0.41 to -0.22) Low (-0.46 to -0.15) Low (-0.43 to 0.09) Low CI = confidence interval; SMD = standardized mean difference; SNRI = serotonin-norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. VASOMOTOR SYMPTOMS Estrogens of any dose were more effective than other comparators without meaningful differences according to dose or route of administration. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. SEXUAL FUNCTION Domain, # of Comparisons Comparators Effect Size (SMD) (95% CI) Pain (lower is better) 10 Vaginal estrogens vs. plac (-0.73 to -0.34) High 4 Oral estrogens vs. plac (-0.35 to -0.09) Moderate Activity (higher is better) SSE/4 weeks (95% CI) 8 Testosterone (7 patch, 1 oral), all trials 1.17 (0.88 to 1.46) a Moderate CI = confidence interval; SMD = standardized mean difference; SNRI = serotonin-norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor. SSE = satisfying sexual episode; a Number of satisfying sexual episodes per four weeks AHRQ Publication No. 15-EHC005-EF. reports/final.cfm.

9 UROGENITAL ATROPHY Number of Comparators Comparisons 3 Ospemifene vs. 12 Vaginal estrogen vs. 14 Nonvaginal estrogen vs. 5 Isoflavones vs. Effect Size (SMD) (95% CI) (-1.05 to -0.45) High (-0.65 to -0.23) High (-0.44 to -0.26) High (-0.77 to -0.18) Low CI = confidence interval; SMD = standardized mean difference. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. OSPEMIFENE TABLET: BOXED WARNINGS Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. ( OSPEMIFENE TABLET: BOXED WARNINGS Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. May increase risk of stroke and DVT. ( LONG-TERM HORMONE THERAPY Outcome Risk Treatment vs. Placebo Comment Breast cancer Estrogen/ High Estrogen Low Inconsistent Gallbladder Estrogen/ Moderate Consistency disease a unknown with 1 trial Estrogen Moderate Consistency unknown with 1 trial Venous thromboembo lic events b Estrogen/ Moderate Consistency unknown with 1 trial Estrogen High a Risk may be lower with transdermal estrogen. b Risk may not be increased with transdermal estrogen. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. Long-term hormone therapy Risk Treatment vs. Placebo Stroke Estrogen+ Estrogen High Ovarian cancer Colorectal cancer Estrogen + Estrogen + Comment Moderate Consistency unknown with 1 trial Low Consistency unknown with 1 trial; imprecise with few cases Low Consistency unknown with 1 trial; imprecise with wide confidence interval Estrogen Moderate Consistency unknown with 1 trial AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. Risk: increased, decreased, no change. Long-term hormone therapy, contd Risk Treatment vs. Placebo Coronary heart disease Endometrial cancer Osteoporotic fractures Estrogen + Strength of Moderate Comment Consistency unknown with 1 trial Estrogen Moderate Consistency unknown with 1 trial Estrogen + Estrogen + Moderate Imprecise Moderate Inconsistency between 2 trials Estrogen Moderate Consistency unknown with 1 trial AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. Risk: increased, decreased, no change.

10 LONG-TERM EFFECTS OF NONHORMONE THERAPY PREPARATIONS Outcome Risk Treatment vs. Placebo Breast cancer Vitamin E High Breast cancer SSRI Insufficient Colorectal Cancer Vitamin E High Cardiovascular events Vitamin E High Cardiovascular deaths Vitamin E Low Osteoporotic fractures SSRI Low Osteoporotic fractures Isoflavones Insufficient Ovarian cancer Vitamin E Insufficient AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. Risk: increased, decreased, no change. CONCLUSIONS From a large body of evidence, there is considerable certainty that estrogens are the most effective treatment for relieving vasomotor symptoms and are accompanied by the greatest improvement in quality-of-life measures. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. CONCLUSIONS, CONTD Estrogens are accompanied by potential long-term harms that require consideration. There is limited evidence on the potential consequences of long-term use of nonhormonal agents when those agents are used to treat menopausal symptoms. AHRQ Publication No. 15-EHC005-EF. reports/final.cfm. WHAT IS MSFLASH? Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network. Placebo-controlled RCTs: mg escitalopram/d nonaerobic yoga aerobic exercise omega-3 fatty acid supplementation 1.8 g/d low-dose oral 17-beta-estradiol (E2) 0.5 mg/d low-dose venlafaxine XR 75 mg/d. HOT FLASHES: MSFLASH HOT FLASHES: MSFLASH An analysis of pooled individual-level data from RCTs 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week. (Guthrie et al Obstet Gynecol 2015) 8-week reduction in vasomotor symptom frequency from baseline relative to was similar for: escitalopram at -1.4 per day (95% CI -2.7 to -0.2), low-dose E2 at -2.4 (95% CI -3.4 to -1.3), venlafaxine at -1.8 (95% CI -2.8 to -0.8) No effects on vasomotor symptom frequency or bother were seen with aerobic exercise, yoga, or omega-3 supplements. (Guthrie et al Obstet Gynecol 2015)

11 PLACEBO EFFECT FOR HOT FLASHES PLACEBO EFFECT FOR HOT FLASHES Data pooled from Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network, combined group (n = 247). Hot flash frequency diaries during treatment (Weeks 0-8) and subsequent follow-up (Weeks 9-11). 1 outcome: clinically significant improvement, defined as a 50% decrease in hot flash frequency from baseline and calculated for each week in the study. (Freeman et al Psychosom Med 2015) Clinically significant improvement with each treatment week, 33% significantly improved at Week 8. Of responders who were improved at both Weeks 4 and 8, 77% remained clinically improved at Week 11 after treatment ended. Thus: Clinically significant improvement with accrued throughout treatment with a time course similar to improvement with active drug, and meaningful number of participants in the group sustained a clinically significant response after stopping pills. (Freeman et al Psychosom Med 2015) REFERENCES Corbelli et al Low-dose transdermal estradiol for vasomotor symptoms: a systematic review. Menopause Jan;22(1): Benkhadra et al Menopausal Hormone Therapy and Mortality: A Systematic Review and Meta-Analysis. J Clin Endocrinol Metab Nov;100(11): Garcia et al Systematic review of acupuncture to control hot flashes in cancer patients. Cancer Nov 15;121(22): Ee et al Acupuncture for Menopausal Hot Flashes: A Randomized Trial. Ann Intern Med Feb 2;164(3): Boardman et al Hormone therapy for preventing cardiovascular disease in postmenopausal women. Cochrane Database Syst Rev Mar 10;3:CD Stuenkel et al. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab Nov;100(11): REFERENCES Manson et al Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA Oct 2;310(13): Chiu et al Effects of acupuncture on menopause-related symptoms and quality of life in women in natural menopause: a meta-analysis of randomized controlled trials. Menopause Feb;22(2):

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