menopause management in 21st century - amazon s3 · diagnosing menopause • don’t –check fsh,...
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Menopause Management
in 21st century
Dr Elizabeth Farrell AM Hon LLD FRANZCOG FRCOG
Head, Menopause Unit, Monash Health
Acting Medical Director, Jean Hailes
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Disclosure Statement
• Speakers bureau, Expert panel and Consultant:
− Bayer HealthCare
− Wyeth Pharmaceuticals (now Pfizer)
− Flordis
• Director:
− Jean Hailes for Women’s Health (a not-for-profit charity)
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Stages of reproductive aging
• Average duration of peri-menopause 4-6 years (range 1-10 years)
• Average age of menopause is 51 years (range 45-55 years)
• Average duration of menopausal symptoms 5-8 years (range 0-13 years)
Harlow et al., Fertil & Steril, 2012
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LOOP – double ovulation
Contraception required until 12 months or 2 years after FMP depending on age.
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Symptoms across the transition
Perimenopause symptoms
-Mood changes
-Sore breasts
- Bloating
-Headaches/migraines
-Periods: irregular in flow & pattern & symptoms
Menopause symptoms
Vaginal dryness-
Low libido-
Urogenital symptoms-
-Hot flushes
-
-
disturbances
-
-
-
-
-Hot flushes
-Night sweats
-Sleep
disturbances
-Formication
-Joint pains
-Irritability
-Fatigue
80% some
80% some
symptoms
80 % mild to 80 % mild to
moderate
symptoms
80% have
symptoms
for < 5 years
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Factors influencing menopausal
symptoms
Menopausal symptoms
Cause of menopause
Other health issues
Cancer treatments
Psychological issues
Socioeconomic/ education
Age Ethnicity
and culture
Lifestyle
Climate
Attitude to menopause/
aging
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Diagnosing Menopause • DON’T
– Check FSH, LH, oestradiol or testosterone levels in a woman
with symptoms around the expected age of menopause (over 45
years)
• these results are unlikely to change your management. The indications for
intervention are clinical.
• DO
– Take a good history of menopausal symptoms, preferably using
a standardised symptom measurement system
– Record personal and family medical history and risk factors incl.
breast cancer, thromboembolic disease and osteoporosis
– Investigate appropriately
Because you will offer help to the woman with symptoms and
these factors will influence what treatments you advise!
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Management is about an holistic approach to improving
health and wellbeing
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Hormone Replacement Therapy (Menopause Hormone Therapy)
• The appropriate time to initiate HRT is at the onset of symptoms, i.e. near the menopause.
• HRT should be part of an overall strategy • including lifestyle recommendations regarding diet,
• smoking cessation,
• exercise and
• safe alcohol consumption to maintain health of peri and post menopausal women.
• The option of HRT is an individual decision in terms of: – Quality of life and health priorities as well as
– Personal risk factors such as age, time since menopause and
– The risk of venous thromboembolism, stroke, ischemic heart disease and breast cancer.
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Vasomotor Symptoms
* Global Consensus Statement on Menopausal Hormone Therapy de Villiers TJ. Climacteric 2013;16:203–204.
• HRT/MHT is the most effective
treatment for vasomotor symptoms
associated with menopause at any age,
with:
– Benefits more likely to outweigh risks for
symptomatic women before the age of 60
years or within 10 years after menopause.
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Osteoporosis
• HRT/MHT is effective and appropriate
for the prevention of osteoporosis-related
fractures in at-risk women before age 60
years or within 10 years after menopause.
• (Treatment of osteoporosis in under 60
years)
* Global Consensus Statement on Menopausal Hormone Therapy de Villiers TJ. Climacteric 2013;16:203–204.
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Oestrogen only
• RCTs, observational data and meta-analyses show that standard-dose estrogen-alone HRT/MHT: may decrease
– coronary heart disease and
– all-cause mortality in women younger than 60 years of age and within 10 years of menopause.
• Oestrogen as a single systemic agent in women after hysterectomy
– but additional progestogen is required in the presence of a uterus.
* Global Consensus Statement on Menopausal Hormone Therapy de Villiers TJ. Climacteric 2013;16:203–204.
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Oestrogen/Progestogen
• Oestrogen plus progestogen HRT/MHT in this
population show:
– a similar trend for mortality
– most randomized clinical trials no significant increase
or decrease in coronary heart disease
• The increased risk of breast cancer/ VTE risk is
primarily associated with the addition of a progestogen
to estrogen therapy and related to the duration of
use. • Breast cancer /VTE risk is greater in women using medroxyprogesterone
acetate (Provera) than in those receiving other progestins,
• Progesterone appears safest.
* Global Consensus Statement on Menopausal Hormone Therapy de Villiers TJ. Climacteric 2013;16:203–204.
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The risk of breast cancer with MHT
The risk of breast cancer in women over 50
years associated with MHT is a complex issue.
• The increased risk of breast cancer is primarily
associated with the addition of a progestogen to
estrogen therapy and related to the duration of
use.
• The risk of breast cancer attributable to MHT is
small and the risk decreases after treatment is
stopped.
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Risk of VTE
• The risk of venous thromboembolism and ischaemic stroke increases with oral MHT – but the absolute risk is rare below age 60 years.
• Observational studies point to a lower risk with transdermal therapy. – MHT-related risk for VTE depends on the route of
oestrogen administration and type of progestogen. • Transdermal oestrogens have a minimal effect on haemostasis.
• Tibolone no increase in VTE risk
• The combination of oral oestrogen use with other VTE risk factors dramatically enhances VTE risk.
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Hormone Replacement Therapy
• Perimenopause & first 2 years postmenopausal – Cyclic therapy E+P
• Post menopausal (> 2 – 3 years) – Continuous therapy E+P
– Tibolone
• Post hysterectomy – Continuous E
– Tibolone
• Premature or Early – High dose till age 50
– Surgical menopause E only +/- Testosterone
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Duration of Therapy
The dose and duration of MHT should be consistent
with treatment goals and safety issues and should be
individualised.
• In women with premature menopause,
– Systemic high dose HRT is recommended at least
until the average age of expected menopause.
• The use of custom-compounded bioidentical
hormone therapy is not recommended.
• Current safety data do not support the use of MHT
in breast cancer survivors.
* Global Consensus Statement on Menopausal Hormone Therapy de Villiers TJ. Climacteric 2013;16:203–204.
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HRT after 60 years
• Vasomotor symptoms persist on average of 7.4 years and >10 years in 10% of women.
• Moderate to severe vasomotor symptoms documented in 42% of women aged 60 to 65 years.
• Many women will continue to have vasomotor symptoms after age 65,
• Disrupt sleep and adversely affect health and quality of life.
• The decision to continue or discontinue HRT should be made jointly by the woman and her healthcare provider.
NAMS position statement 2015
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Resources
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AMS Guide to Equivalent HRT Doses
http://www.menopause.org.au/images/stories/infosheets/docs/AMS_
Guide_to_Equivalent_HRT_Doses_2015.pdf
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Jean Hailes
Menopause Management
GP Tool
• Phases of Menopause
• Common Symptoms
• Routine Checks
• Hormone Replacement Therapy
• Special Conditions
• Bone Health
• Emotional Health
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Genitourinary syndrome of the menopause
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Genitourinary Syndrome of
Menopause
• Symptoms and signs due to low oestrogen and other sex steroids – changes to the labia majora/minora, clitoris,
vestibule/introitus, vagina, urethra and bladder.
– may include • genital symptoms of dryness, burning, and irritation;
• sexual symptoms of lack of lubrication, discomfort or pain, loss of libido and impaired function; and
• urinary symptoms of urgency, dysuria and recurrent urinary tract infections.
– may present with some or all of the signs and symptoms,
» Portman D. 2014,
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Oestrogen only
• Local/Vaginal
• low-dose oestrogen
therapy
– Oestriol cream
– Low dose 10mcg oestradiol tablet
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Vaginal Oestradiol
• Oestradiol 10ug vaginal tablet
• with an annual estrogen exposure of only 1.14
mg.
• displays minimal systemic E2 absorption,
• has no increased risk of endometrial
hyperplasia or carcinoma and
• improved management of the symptoms of
estrogen deficiency-induced vaginal atrophy
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Non hormonal therapies
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Medication Reduction in HF (versus placebo)
Duration of studies
Additional benefits
Adverse effects
SNRI
Desvenlafaxine 100mg/day
64% (vs 51%) 1 year Improved sleep GIT, sexual dysfunction, Discontinuation syndrome
Venlafaxine SR 75mg/day
60% (vs 27%) 8 weeks
SSRI
Escitalopram 10-20mg/day
55% (vs 38%) 8 weeks Improved sleep, mood, QOL. No effect on sexual function
No discontinuation syndrome at 10mg
Citalopram 10-40mg/day
49% (vs23%) 6 weeks-9 months
Fluoxetine 20 mg/day
6 weeks-9 months
Interferes with tamoxifen GIT, insomnia
Paroxetine 7.5- 12.5mg
40-56% (vs 28-37%)
6-24 weeks Improved mood Improved sleep with low dose
Interferes with Tamoxifen GIT, insomnia No discontinuation syndrome at 7.5mg dose
Nelson et al., JAMA 2006; Rada et al., Cochrane review 2009; Loprinzi et al., JCO 2009
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Medication Reduction in HF (versus placebo)
Duration of studies
Additional benefits
Adverse effects
Gabapentin 900-2400mg/day in divided doses
50-80% (vs 20-40 %)
8 weeks Improved sleep Decreased pain at week 4 Improved sleep, mood, QOL
Dizziness, drowsiness Weight gain with higher dose?
Pregabalin 75-150mg bd
60% (vs 36%) 6 weeks
Clonidine 25mg bd to 50mgbd
40% (vs 38%) 4-8 weeks Only agent listed on PBS
Dry mouth
Nelson et al., JAMA 2006; Rada et al., Cochrane review 2009; Loprinzi et al., JCO 2009
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Treatment: Vasomotor symptoms:
Effective non- drug treatments
Therapy Effectiveness
Cognitive behavioural therapy Reduction in bothersomeness of VMS by 30-40% at 6 months. Improved mood, sleep, sexual function, QOL 1
Acupuncture 40% reduction in VMS 2
Hypnosis Limited evidence of benefit 3
1. Ayers et al., Menopause 2013; 2. Chui et al., Menopause 2014; 3. Elkins et al., Menopause 2013.
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Treatment: Vasomotor symptoms: Watch this space…..
Therapy Effectiveness
Stellate ganglion block Pilot study: 50% reduction in VMS
Magnesium Pilot study- promising
Folic acid Pilot study- promising
Paced respiration Conflicting evidence
Weight loss Pilot study- promising
Yoga Pilot study -promising
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No proven benefit and/or safety unknown
SOY
HERBS
HOMEOPATHY
VITAMIN E OMEGA-3
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New Therapies
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New therapies
• Gynoflor • Low dose oestriol /lactobacillus combined vaginal preparation,
improved symptoms in Breast cancer patients on AIs • Donders et al 2014
• Ospemifene • non-steroidal oral estrogen receptor agonist/antagonist, (ERAA)
• oestrogen agonist effect in the vaginal epithelium
• improved the vaginal maturation index (decreased parabasal cells and increased superficial cells),
• decreased vaginal pH, and
• decreased severity of the self-identified most bothersome symptom (dyspareunia or vaginal dryness) compared to placebo.
• Side effect hot flushes 13% • Simon J Climacteric 2013
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New therapies
• Prasterone • Daily intravaginal prasterone (DHEA) (0.50%; 6.5
mg) treatment.
• Significant beneficial effects
– Lower percentage of vaginal parabasal cells, higher
percentage of vaginal superficial cells, vaginal pH,
– Reduction in moderate to severe dyspareunia
• No significant drug-related adverse effect
– Archer D et al 2015
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New Therapies
• Conjugated oestrogens/ bazedoxifene
– TSEC tissue-selective estrogen complex – CE+ BZA (SERM))
– Approved in the United States and Europe
– Indicated for management of menopausal symptoms in women with intact uteri
• Neutral effects on the uterus and on breast tissue (SERM effect)
• Potential for skeletal benefit as CE and BZA are effective for fracture risk reduction
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Menopause 2014
• HRT in healthy women
50-59 years who are
symptomatic is low risk
• Duration of therapy
depends on duration of
symptoms and an
annual risk /benefit
analysis
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Menopause 2014
• Complex hormonal
changes as
periods cease.
• Quality of
life/Symptoms
– Management strategies • Knowledge
• Self help strategies
• HRT
• Non hormonal therapies