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CMECNE

North American Menopause Society: Hormone Therapy Statement

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. List the contraindications for hormonal therapy
2. Discuss the FDA approved indications for hormonal therapy

Estimated time to complete activity: 0.5 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Dec 31 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.4 contact hours.

Designated for 0.3 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

SUMMARY:

NAMS updated its position statement on hormone therapy (2017), based on an extensive literature review. Hormone therapy (HT) is the most effective treatment for vasomotor symptoms (VMS; hot flashes, night sweats) and genitourinary syndrome of menopause (GSM).

Contraindications for HT
Potential risks of HT
FDA approved indications for HT
NAMS recommendations for type / regimen / duration of use
NAMS recommendations for special populations and cancer risk
Hormonal therapy dosage / regimens
Key points
Learn more

CONTRAINDICATIONS FOR HT

    • Unexplained vaginal bleeding
    • Severe active liver disease
    • Prior estrogen-sensitive breast or endometrial cancer
    • Coronary heart disease
    • Stroke
    • Dementia
    • Personal history/inherited high risk of thromboembolism
  • Other: porphyria cutanea tarda, hypertriglyceridemia, endometriosis/leiomyoma with concern for worsening symptoms or growth

POTENTIAL RISKS OF HT

Women < 60 years or who are within 10 years of menopause

  • Breast cancer (rare risk) with combined estrogen-progestogen therapy
  • Endometrial hyperplasia and cancer with unopposed estrogen
  • VTE
  • Biliary issues

Women across the age spectrum

  • MI
  • Stroke
  • Dementia

FDA APPROVED INDICATIONS FOR HT

(Level I: Based on good and consistent scientific evidence / Level II: Based on limited or inconsistent scientific evidence / Level III: Based primarily on consensus and expert opinion)

  • Bothersome vasomotor symptoms (Level I)
  • Prevention of bone loss (Level I)
  • Hypoestrogenism caused by hypogonadism, surgical castration or premature ovarian insufficiency (Level II)
  • Genitourinary symptoms (Level I)

NAMS RECOMMENDATIONS FOR TYPE / REGIMEN / DURATION OF USE

Individualize type, dose & regimen

  • For women with a uterus and using systematic estrogen, ensure endometrial protection (Level I)
    • Use adequate dose and duration of a progestogen
      • In WHI, addition of medroxyprogesterone acetate 2.5 mg daily resulted in same risk of endometrial cancer as placebo (hazard ratio 0.81 (95% CI 0.48-1.36)
    • combine conjugated equine estrogens (CEE) with bazedoxifene
  • Progestogen therapy not recommended for low-dose vaginal ET (Level I)
    • Evaluate endometrium if bleeding does occur
  • Lower doses/transdermal HT may be appropriate in women with metabolic syndrome that include hypertriglyceridemia / risk of pancreatitis / fatty liver (Level III)
  • Avoid compounded bioidentical HT given concerns about safety (Level I)
  • Do not use salivary hormone testing to dictate dosing

Individualize duration

  • Premature menopause, either natural or induced < age 45 and especially if < age 40
    • Continue HT at least until age 52, which is the median age of menopause (Level II)
  • The recommendation to routinely discontinue HT in women aged 65 and older is not supported by data
  • Decision to continue > 60 years of age includes quality of life, VMS, bone loss/fracture and other medical risks vs benefits (Level III)

NAMS RECOMMENDATIONS FOR SPECIAL POPULATIONS AND CANCER RISK

Family history of breast cancer

  • Use of HT does not appear to increase risk (Level II)
  • Family history is a risk factor for breast cancer and should be assessed when counseling about HT

BRCA positive without breast cancer

  • For BRCA positive women who have undergone prophylactic oophorectomy, risks due to premature loss of estrogen need to be considered (Level II)
  • Limited observational studies suggest HT until age 52, then individualize (Level II)

Ovarian Cancer

  • Data does not support estrogen as an initiator or promotor of epithelial ovarian cancer
    • In WHI, no increased risk of ovarian cancer with CEE + medroxyprogesterone acetate (5.6 years’ therapy with 13 years follow-up)
    • If association between HT and ovarian cancer exists, absolute risk likely to be rare (<1/1,000) or very rare (<0.01/1,000) and related to duration of use
  • Limited data has not demonstrated increased risk in women with family history of ovarian cancer or BRCA mutation carriers who use estrogen-progestogen therapy
  • Observational data inconsistent with some (not all studies) demonstrating increased risk after 5 to 10 years
  • Data limited on ER+ tumors such as low-grade serous carcinomas and sex cord stromal malignancies

Breast and endometrial cancer survivors: Systemic HT for VMS

  • Encourage nonhormonal therapies (Level III)
  • Endometrial cancer survivor
    • If VMS not well controlled, may consider HT in conjunction with oncologist (Level III)
  • Breast cancer survivor (especially ER+)
    • Systemic HT should not be offered but if other nonhormonal alternatives have failed, shared decision making that includes an oncologist can be considered

Breast and endometrial cancer survivors: Low-dose vaginal ET

  • Low-dose vaginal ET has minimal systematic absorption and appears to hold minimal to no risk for breast or endometrial cancer (Level II)
  • Endometrial cancer survivor following hysterectomy and successful treatment
    • Consider low-dose vaginal ET in nonhormonal options are unsuccessful (Level II)
  • Breast cancer survivors
    • Decisions regarding low-dose vaginal estrogen should involve the treating oncologist especially if patient is on aromatase inhibitors (Level III)

HORMONAL THERAPY DOSAGE/REGIMENS

NOTE: For women with a uterus and using systematic estrogen, ensure endometrial protection with an adequate dose of a progestogen

VSM – systemic

Note:

  • Standard Dose
    • Conjugated estrogen 0.625 mg/d
    • Micronized estradiol-17β 1 mg/d
    • Transdermal estradiol-17β 0.0375–0.05 mg/d
  • Low Dose
    • Conjugated estrogen 0.3–0.45 mg/d
    • Micronized estradiol-17β 0.5 mg/d
    • Transdermal estradiol-17β 0.025 mg/d
  • CEE + SERM
    • Conjugated estrogen 0.45 mg/d and bazedoxifene 20 mg/d
  • 19-nortestosterone derivative synthetic steroid
    • Tibolone 2.5 mg/d
  • Progestin
    • Not recommended as first line therapy due to safety concerns related to breast cancer risk
    • Depot medroxyprogesterone acetate 400 mg demonstrated to improve VSM symptoms in RCT
      • Not FDA approved for this indication
  • Combined estradiol and progesterone capsules
    • 1 capsule (1 mg/100 mg) /d
    • Bioidentical therapy
    • Molecularly identical to circulating hormones (see ‘Related ObG Topics’ below)

GSM – systemic

  • Standard Dose
    • Conjugated estrogen 0.625 mg/d
    • Micronized estradiol-17β 1 mg/d
    • Transdermal estradiol-17β 0.0375–0.05 mg/d
  • Low Dose
    • Conjugated estrogen 0.3–0.45 mg/d
    • Micronized estradiol-17β 0.5 mg/d
    • Transdermal estradiol-17β 0.025 mg/d

PROGESTOGENS FOR UTERINE PROTECTION – when using standard dose estrogen

  • Medroxyprogesterone acetate
    • 2.5 mg po daily for continuous therapy
    • 5 mg daily po with sequential therapy for 12 – 14 days sequentially per 28-day cycle (start day 1 or 16)
  • Micronized progesterone
    • 100 mg po daily for continuous therapy
    • 200 mg po nightly for 12 days sequentially per 28-day cycle
    • Formulated with peanut oil – do not use in women with peanut allergies
    • May cause hypnotic effects and should be taken at bedtime

GSM – local (vaginal, and in the case of creams may also be applied to vestibular area)

  • Estradiol-17β ring (releases 7.5 micrograms/d): replace every 3 months
  • Estradiol vaginal tablet (10 micrograms/d): place nightly for 2 weeks
    • Maintenance is one tablet 2 times/week
    • Note: this is the corrected dose in ACOG PB 141
  • Estradiol-17β cream (0.1 mg active ingredient/g):  2-4 g/d for 1 to 2 weeks
    • Gradually reduce to ½ initial dosage for 1 – 2 weeks
    • Maintenance is 1 g, 1 to 3 times/week
  • Conjugated estrogen cream (0.625 mg/g):  0.5–2 g/d for 21 days then off for 7 days
    • In practice during maintenance therapy, most women apply 1 – 3 times /week
  • Vaginal inserts (4-μg and 10-μg)
    • 1 vaginal insert daily for 2 weeks
    • Maintenance is 1 insert twice weekly

KEY POINTS:

  • Risks of HT differ depending on type/dose/duration/route/timing of initiation and whether a progestogen is needed
    • Individualize treatment to maximize benefits/minimize risk
    • Reassess periodically
  • Women younger than 60 or within 10 years of menopause without contraindications have a favorable benefit-risk ratio for use of HT in the treatment of VMS and reducing bone loss/fracture for those at increased risk
    • Longer duration may be more favorable for estrogen therapy alone vs combined estrogen-progestin therapy based on the WHI RCTs
  • Women who begin HT more than 10 years from menopause onset or aged 60 or older have a less favorable benefit-risk ratio, with greater absolute risks of CHD, stroke, thrombosis and dementia
  • Low-dose vaginal estrogen therapy is recommended for GSM symptoms not relieved with other therapies

The USPSTF Guidance on the Role of Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Women (December 2017)

  • The USPSTF assessed the evidence for harms and benefits for chronic disorders such as coronary heart disease, dementia, stroke, fractures, and breast cancer
  • The magnitude of both the benefits and the harms of hormone therapy in postmenopausal women is small to moderate
  • The USPSTF concludes with moderate certainty that there is no net benefit in the use of hormone therapy
    • The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal women. (*D recommendation)
    • The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal women who have had a hysterectomy (*D recommendation)

*D recommendation Suggestion for Practice: Discourage the Use of This Service


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Learn More – Primary Sources:

The 2017 hormone therapy position statement of The North American Menopause Society

Scientific Background Report for the 2017 Hormone Therapy Position Statement of The North American Menopause Society

ACOG Practice Bulletin 141: Management of Menopausal Symptoms

Practice Bulletin 141: Management of Menopausal Symptoms: Correction

Perspective on prescribing conjugated estrogens/bazedoxifene for estrogen-deficiency symptoms of menopause: a practical guide

Kaunitz and Manson: Management of Menopausal Symptoms

USPSTF: Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Women

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Related ObG Topics:

Treating Postmenopausal Vaginal Atrophy When Estrogen is Not an Option
Practical info on evidence based medicine for your women's healthcare practice
Does Estrogen Therapy Have Cardiovascular Benefit in Early Postmenopause?
Does Hormone Therapy Protect Against Alzheimer’s?
What Are Bioidentical Hormones?
Genitourinary Syndrome of Menopause: New Name, Old Problem
Local Estrogen Treatment Options for Vaginal Atrophy

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