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Therapeutics > Exam 3 Menopausal Hormone Therapy (MHT) > Flashcards

Exam 3 Menopausal Hormone Therapy (MHT) Flashcards

1
Q

What is menopause?

A

a natural biological event that marks a woman is no longer fertile (no more eggs) → causes a large drop in estrogen

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2
Q

How is menopause diagnosed?

A

diagnosis is confirmed after 12 consecutive months of amenorrhea (absence of period)

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3
Q

What are the three phases of menopause?

A
  1. premenopause → the time period of endocrine changes BEFORE cessation of menstruation
  2. perimenopause (climacteric) → the period of endocrine changes SURROUND the menopause (usually occur 2-8 years prior to when menopause occurs when most symptoms occur and there are changes in the cycle: cycle can be lengthened but the period itself is shorter in duration)
  3. postmenopause → the time period of endocrine changes AFTER cessation of menstruation
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4
Q

What is the typical age of onset of menopause?

A

51 years (can range from 40-58) → life expectancy for women is 81 years so women spend 40% of lives postmenopausal

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5
Q

What is premature menopause?

A
  1. also called premature ovarian insufficiency (POI)
  2. occur before the age of 40
  3. hysterectomy, radiation therapy, chemotherapy → all causes
  4. 1% of women develop premature ovarian failure before 40
  5. increase risk of mortality and morbidity
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6
Q

What are symptoms like during menopause?

A
  1. worst symptoms occur during first 1-2 years

2. symptoms last 7+ years for most women

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7
Q

What are some causes of menopause?

A
  1. physiologic → extensive deterioration of the follicular cells and ova with aging (women are born with a million follicles at birth and have about 2.5% left after age 37)
  2. surgical → removal of ovaries (may have more severe symptoms than physiological menopause)
  3. other → breast cancer chemotherapy
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8
Q

What are the two vasomotor symptoms associated with menopause?

A
  1. hot flashes → sudden sensation of heat and perspiration and then can get chills and shivers
  2. night sweats

50-87% women experience it → vasomotor symptoms can get better but vaginal symptoms may get worse

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9
Q

What are other clinical presentations of menopause?

A
  1. irregular menses
  2. episodic amenorrhea
  3. sleep disturbance
  4. mood changes (depression, irritability) → women with depression are 5 times more likely to get mood changes during menopause
  5. fatigue
  6. vulvovaginal atrophy (vaginal dryness, dyspareunia) → lots of estrogen receptors in vaginal area
  7. urinary tract dysfunction → vaginal pH change
  8. sexual dysfunction
  9. urinary frequency, urgency
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10
Q

What are some long term consequences of menopause?

A
  1. cardiovascular disease
  2. bone loss
  3. osteoarthritis
  4. body composition
  5. skin changes
  6. balance
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11
Q

What are some options of treatment of menopausal symptoms?

A
  1. nonpharmacologic therapy
  2. menopausal hormone therapy (MHT) aka HRT → estrogen only, estrogen and progestin, estrogen and selective estrogen receptor modulator (SERM)
  3. nonhormonal alternatives
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12
Q

What are fibroids?

A

noncancerous tissue in the uterus

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13
Q

What are some nonpharmacological treatments for menopause?

A
  1. smoking cessation → smoking reduces estrogen concentration → more likely to get menopause earlier
  2. limit alcohol and caffeine use
  3. limit hot beverages (coffee, tea, soups)
  4. limit spicy foods
  5. weight loss
  6. keep cool, dress in layers
  7. others: increase exercise, acupuncture, yoga, paced respiration, clinical hypnosis, cognitive behavior therapy, stress reduction
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14
Q

What are some indications for menopausal hormone therapy?

A
  1. vasomotor symptoms
  2. vulvovaginal atrophy
  3. osteoporosis prevention
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15
Q

What are some absolute contraindications to MHT?

A
  1. unexplained vaginal bleeding
  2. pregnancy
  3. estrogen dependent malignancies → endometrial cancer, breast cancer
  4. stroke + heart attacks
  5. active thromboembolic disorders (or prior history)
  6. active liver disease
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16
Q

What are some relative contraindications to MHT?

A
  1. uterine leiomyoma
  2. migraine headaches with aura
  3. seizure disorders
  4. diabetes
  5. hypertriglyceridemia (>400 mg/day)
  6. active gallbladder disease
  7. high risk for heart disease
  8. family history of breast cancer

can use MHT but just monitor for there and good to go!

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17
Q

Estrogen monotherapy is only used when?

A

only for women without an uterus → increased risk of endometrial cancer for those with uterus

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18
Q

What are the different estrogen monotherapy products?

A

oral, transdermal, other topical products, intravaginal products, intramuscular injections

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19
Q

What are some oral estrogen monotherapy products?

A
  1. Premarin (conjugated estrogens)
  2. Menest (esterified estrogen)
  3. Estrace generics (micronized estradiol)
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20
Q

What are some transdermal estrogen monotherapy products?

A
  1. Alora
  2. Climara
  3. Menostar
  4. Minivelle
  5. Vivelle
  6. Vivelle-Dot

gives continuous rate of estrogen, no first pass metabolism, less side effects

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21
Q

What are some other topical products of estrogen monotherapy?

A
  1. topical gel → EstroGel, Divigel, Elestrin
  2. topical spray → Evamist

don’t really recommend it because systemic absorption can vary → breast enlargement

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22
Q

What are some intravaginal products for estrogen monotherapy?

A
  1. vaginal cream → Estrace, Premarin
  2. vaginal insert → Imvexxy
  3. vaginal tablet → Vagifem, yuvafem
  4. vaginal ring → Estring, Femring

if have uterus, don’t need progesterone since it is little concentration vaginally (for Femring, need progesterone for endometrial protection for those with uterus since there is higher systemic estrogen concentration) → ring is bigger than string!

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23
Q

What are some intramuscular injections for estrogen monotherapy?

A
  1. estradiol cypionate (Depo-Estradiol)
  2. estradiol valerate (Delestrogen)

administered every 3-4 weeks for compliance

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24
Q

What are some estrogen therapy principles?

A
  1. oral or transdermal estrogen products should be prescribed at the appropriate dose, duration, regimen, and route of administration that provide the most benefit with the minimal amount of risk
  2. topical vaginal products should be prescribed for women exclusively experiencing vulvovaginal atrophy → since want localized treatment
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25
Q

What is the progestin use principle?

A

women with an intact uterus should be prescribed a progestin in addition to estrogen in order to decrease the risk of endometrial hyperplasia and endometrial cancer

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26
Q

According to the WHI study, what were the results for women with uterus intact?

A
  1. increased heart attacks, strokes, venous thromboembolism, invasive breast cancers
  2. decreased colorectal cancers and hip fractures
27
Q

According to the WHI study, what were the results for women with no uterus intact?

A
  1. increased strokes, venous thromboembolism
  2. no significant different in CHD (heart attacks, coronary heart disease), invasive breast cancers
  3. no difference in colorectal cancers
  4. decrease in hip fractures
28
Q

What are the 2 critical factors in determining whether hormone therapy reduces or increase risk of CHD?

A
  1. age of initiation

2. time since menopause

29
Q

What are some of the results of the estrogen only study?

A
  1. women <60 years, within 10 years of menopause, no evidence of CHD → younger women will be the ones that benefit most from therapy
  2. women >10 years of menopause, increase risk of CHD within first 2 years → women 70-79 years and >20 years of menopause is at highest risk
  3. women with established CHD have no additional benefits
30
Q

What is the overall takeaway from the WHI studies?

A
  1. women with intact uterus was significantly associated with a higher risk of breast cancer and no significant difference in cancer mortality → combo therapy reduces risk of colorectal cancer and fractures
  2. women with prior hysterectomy had significantly lower risk of breast cancer incidence and no significant difference in cancer mortality → aka estrogen monotherapy
31
Q

What are the current recommendations for MHT?

A

initiation of treatment should be limited to women age < 60 OR within 10 years of last period (target the younger group since they have the most favorable risk benefit profile) → most appropriate dose, duration, and routes of administration that provides the most benefits (regimen is individualized so can start low and titrate up)

32
Q

What are the different methods of administration of combined estrogen and progestin therapy?

A
  1. continuous cyclic therapy
  2. continuous long cycle
  3. continuous combined
  4. intermittent combined
33
Q

What are some things to know about continuous cyclic therapy?

A
  1. called sequential treatment → mimic woman’s menstrual cycle
  2. estrogen administered daily
  3. progesterone administered at least 12 to 14 days of a 28 day cycle
  4. scheduled withdrawal bleeding 90% of the time → 12 scheduled bleeds
  5. preferred in recently menopausal women → tend to have more breakthrough bleeds
34
Q

What are some examples of continuous cyclic therapy?

A
  1. Premphase → oral → conjugated estrogens + medroxyprogesterone acetate
  2. Combipatch → transdermal → estradiol + norethindrone acetate
35
Q

What are some things to know about continuous long cycle?

A
  1. it is rare → continuation/extension of continuous cyclic
  2. also called cyclic withdrawal
  3. estrogen administered daily
  4. progesterone co-administered with estrogen for at least 12 to 14 days every other month
  5. results in 6 scheduled bleeds per year
  6. limited safety data, endometrial protection is also unclear
36
Q

What are some things to know about continuous combined therapy?

A
  1. daily estrogen + progesterone
  2. results in endometrial atrophy and absence of vaginal bleeding → no scheduled bleeds
  3. initial unpredictable spotting or bleeding which usually resolves within 6 to 12 months
  4. drug free period of 1-2 weeks may help stop bleeding
  5. recommended for women >2 years post-final menstrual period → already have absence of period
  6. long term endometrial protection is best
37
Q

What are some examples of continuous combined products?

A
  1. Prempro → oral → conjugated estrogens + medroxyprogesterone acetate
  2. Femhrt, Fyavolv → oral → ethinyl estradiol + norethindrone acetate
  3. Angeliq → oral → estradiol + drospirenone
  4. Activella, Amabelz, Mimvey → oral → estradiol + norethindrone acetate
  5. Bijuva → oral → estradiol + progesterone
  6. ClimaraPro → transdermal → estradiol + levonorgestrel
  7. Combipatch → transdermal → estradiol + norethindrone acetate
38
Q

What are some things to know about intermittent combined therapy?

A
  1. continuous pulsed estrogen-progesterone or pulsed progesterone
  2. 3 days of estrogen + progesterone (can be daily estrogen and pulsed progesterone or both is pulsed)
  3. pulsing prevents down regulation of progesterone receptors
  4. long term endometrial protection is unknown
39
Q

What is an example of an intermittent combined product?

A

Prefest → oral → estradiol + noregestimate

40
Q

What is the best progestin to recommend for endometrial protection?

A

micronized progestin → structurally identical to progesterone secreted by the ovaries

41
Q

What are some things to know about estrogen and SERM therapy?

A
  1. also known as tissue selective estrogen complex
  2. SERM is a non-hormonal agent that is an agonist at the bone, antagonist at the breast and uterus, decreases risk of endometrial cancer, overweight women is not recommended (BMI over 27) since levels could decrease so risk of endometrial cancer increases
  3. treats both menopausal symptoms and prevent bone loss in women with intact uterus
  4. side effects: GI tract disorders, muscle spasm, neck pain, dizziness, oropharyngeal pain
42
Q

What is the one example of an estrogen and SERM option?

A

Duavee → oral → conjugated estrogen 0.45 mg + bazedoxifene 20 mg

43
Q

How should we decide on a regimen?

A

preferred is transdermal estrogen +/- progestin

  1. less thromboembolic risk, stroke, and heart attack
  2. less headache, breast tenderness
  3. consider in hypertriglyceridemia, liver disease, gallbladder disease
  4. GI intolerance (nausea/vomiting from oral product)
  5. side effects: skin irritation, skin transfer possible (if topical)
44
Q

What are alternatives to transdermal estrogen +/- progestin?

A
  1. bazedoxifene + estrogen → avoid vaginal bleeding, less breast tenderness, less altered mood (because no progesterone)
  2. oral estrogen +/- progestin
  3. systemic vaginal estrogen +/- progestin → like Femring
45
Q

What are some considerations with recommended treatment duration?

A
  1. no need to routinely discontinue hormone therapy
  2. in older women (age > 60) decide based on an individual basis (quality of life, persistent symptoms, or prevention of bone loss and fracture), after appropriately evaluate all medical risks and counsel patient about potential benefits and risks of hormone therapy and with ongoing surveillance
  3. evaluate patient annually and review comorbidities
  4. consider periodic trials of tapering, stopping, or changing to safer low dose transdermal routes
  5. hormone therapy for 5.6-7.2 years did not affect all cause mortality at 18 years

don’t stop cold turkey!!!

46
Q

What are some alternatives for vasomotor symptoms?

A
  1. phytoestrogens → plant estrogens that are less potent than synthetic estrogens (examples include isoflavones found in soy products, lignans in flax seed, and coumestans in alfalfa sprouts)
  2. black cohosh → use less than 6 months, can cause hepatotoxicity
  3. Dong Quai → Chinese herbal that can increase bleeding when taking anticoagulants
  4. gabapentin/pregabalin → used for mood but can cause sedation and dizziness as side effects
  5. clonidine → an anti-hypertensive that has short half life so hot flashes may reoccur and side effects include sedation and dizziness and dry mouth
47
Q

What are the drugs of choice is no estrogen treatment?

A

SSRIs/SNRIs for hot flashes

48
Q

What are some examples of SSRIs?

A
  1. paroxetine (Brisdelle)
  2. paroxetine (Paxil, Pexeva)
  3. Paroxetine CR (Paxil CR)
  4. Citalopram (Celexa)
  5. Escitalopram (Lexapro)
49
Q

What are some examples of SNRIs?

A
  1. venlafaxine (Effexor)
  2. desvenlafaxine (Pristiq)
  3. side effects: dry mouth, anorexia, nausea, constipation
50
Q

What is bio-identical hormone replacement therapy?

A
  1. compounds with unique mix of estradiol, estrone, estriol, and progesterone → bi-estrogens, tri-estrogens +/- testosterone and come as tablets, patches, compounded creams, gels, injectables
  2. insurance coverage is minimal
  3. no data to support use for compounded products
  4. only 1 FDA approved bio-identical therapy
51
Q

What is the example of the FDA approved bio-identical therapy?

A

Bijuva → oral → estradiol + micronized progestin

expensive about $215 a month

52
Q

What is the management for women within 10 years since menopause + low 10 year CVD risk (<5%)?

A

may use MHT (oral or transdermal)

53
Q

What is the management for women within 10 years since menopause + moderate 10 year CVD risk (5-10%)?

A

avoid oral estrogen but prefer transdermal administration → transdermal have lower risk of side effects

54
Q

What is the management for women with high 10 year CVD risk (>10%)?

A
  1. avoid systemic MHT

2. if genitourinary symptoms, may consider low dose vaginal estrogen or other treatments

55
Q

What is the rule of thumb?

A

avoid systemic MHT for women with moderate to high breast cancer risk (1.67 to >5%)!!!

56
Q

What is the first line treatment (non-hormonal) for genitourinary syndrome of menopause (GSM)?

A
  1. lubricants → short duration of action and frequent applications are needed
  2. vaginal moisturizers → 2-3 applications/week
57
Q

What is second line treatment (estrogen) for GSM?

A
  1. topical → cream, tablet, ring

2. low dose oral contraceptive

58
Q

What are some things to know about using Ospemifene (Osphena) to treat moderate-severe dyspareunia?

A
  1. is a SERM that is an agonist at the vagina and uterus
  2. black box warning of endometrial cancer, stroke, and VTE
  3. 60 mg once daily in postmenopausal women, taken with means
  4. common side effects: vaginal discharge, endometrial hyperplasia, hot flashes (7-12%)
    5 has similar precautions to estrogen therapies
59
Q

What are some things to know about Prasterone (Intrarosa) to treat moderate-severe dyspareunia?

A
  1. inactive DHEA converted to active estrogens and androgens
  2. intravaginal 6.5 mg once daily at bedtime in postmenopausal women
  3. no black box warning for VTE, endometrial hyperplasia
  4. contraindications: undiagnosed vaginal bleeding
  5. avoid if history of breast cancer
  6. common side effects: vaginal discharge (5.7-14%)
  7. cost is $180/month
  8. do not rely on oral DHEA supplements
60
Q

What is first line treatment for moderate-severe symptoms of vulvovaginal atrophy?

A

estrogen based regimen

61
Q

What are the general approaches to management of menopausal symptoms?

A
  1. determine location of symptoms
  2. determine any contraindications
  3. estrogen alone or with progestin
  4. decide route
62
Q

What are some general approaches to management of menopausal symptoms?

A
  1. evidence of moderate/severe menopausal symptoms → moderate/severe vulvovaginal atrophy → yes to hormonal therapy → use vaginal estrogen preparation or ospemifene or prasterone OR use estradiol acetate ring or systemic estrogen (plus progesterone) if also vasomotor symptoms
  2. evidence of moderate/severe menopausal symptoms → moderate/severe vulvovaginal atrophy → no to hormonal therapy → use nonhormonal vaginal moisturizer
  3. evidence of moderate/severe menopausal symptoms → moderate/severe vasomotor symptoms → yes to hormonal therapy → use oral or transdermal estrogen or estradiol acetate intravaginal ring (plus progesterone if uterus) OR use bazedoxifene/conjugated estrogens (only if uterus intact)
  4. evidence of moderate/severe menopausal symptoms → moderate/severe vasomotor symptoms → no to hormonal therapy → use SSRI or SNRI antidepressant, gabapentin/pregabalin, or clonidine OR if taking tamoxifene, avoid paroxetine or fluoxetine or other moderate or strong CYP22D6 inhibitors
63
Q

What is the MHT principle when deciding care to a patient?

A

treatment selected should be tailored to the individual patient and will vary according to each woman’s symptom severity, age, medical profile, personal preference, and estimated benefit/risk ratio (osteoporosis fracture risk, cardiovascular disease risk, breast cancer risk, and thromboembolic risk) → shared decision making approach with the patient and provider!!!

Therapeutics (15 decks)

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