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The Pharmacological Management of Peri-Menopause and Menopause

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The Pharmacological Management of Peri-Menopause and Menopause The Pharmacological Management of Peri-Menopause and Menopause Debora Bear, FNP, MSN, MPH University Of New Mexico Hospital Hormones and other Treatments Disclosure Statement • I have no real or perceived vested interests that relate to this presentation nor do I have any relationships with pharmaceutical companies, biomedical device manufacturers, and/or other corporations whose products or services are related to pertinent therapeutic areas. Objectives: 1. Describe the most common medical issues associated with menopause 2. Apply the scientific evidence regarding the risks and benefits of medical therapies as well as risks and benefits of alternative treatments Case study: 63 year old woman requests a refill of her “bio identical hormone” prescription. She takes this for her duodenitis, tendon pain, urinary incontinence, skin, hot flashes (she has tried EVERYTHING else and it is the ONLY thing that works), memory, leg swelling, varicose veins, bloating (had terrible IBS prior), osteopenia, and vaginal dryness. Does not get mammograms due to concern for “radiation exposure”. Describe the most common medical issues associated with peri-menopause and menopause When is menopause Premature < 40 (1%), • For women who miss three or more consecutives menses, measure HCG, FSH, estradiol, prolactin, TSH • Consider AMH level, vaginal ultrasound, Karyotype and testing for fragile x permutation, thyroid peroxidase antibodies, adrenal antibodies, fasting glucose, serum calcium and phosphorus levels • If not contraindicated: consider estrogen treatment early < 40 < 45 (5%) median age 52 Describe the most common medical issues associated with peri-menopause and menopause • • Contraception Need for use until 12 months after FMP • • Vasomotor Symptoms/ 60%-85% (varies by culture): treat with hormone replacement, SSRIs and SNRIs, CBT • Mood • Vaginal • Systemic replacement may not impact • Bone • Estrogen & decreased risk of hip fracture • Estrogen & stroke risk, memory not improved • Other: cardiovascular, memory, cancer with HRT? • Unopposed estrogen associated with endometrial cancer, Selective Estrogen Receptor Modulators decrease breast cancer Contraception During Peri-Menopause Methods Key Points: -CHC (Pills/Patch/Ring) • Review Medical Eligibility Criteria -Progestin Only • Option to treat hot flashes • When to use/when to remove -LARC -Barrier Methods • Femcap, Diaphragm, condoms Other Benefits from • Treats irregular uterine bleeding, reduce Hormonal Contraception vasomotor symptoms, decrease ovarian and endometrial cancer, maintain bone mineral density Contraception: Case Study A Fifty two year old woman presents for her “annual”. She is on a CHC and has menopause questions. Treatments for Vasomotor Symptoms • Hormones • Estrogen most effective treatment • Contra-indications (heart disease, breast cancer, active liver disease, thromboembolic disease) • Shortest duration (< 4 yrs) • Low dose: < 0.3mg CE, < 5mg oral micronized estradiol < 0.25 µg transdermal estradiol, or < 0.25 µg ethinyl estradiol • Progestogen required for women with a uterus • SSRI/SNRI • FDA-Paroxetine(SSRI) 7.5mg-25mg (not w/Tamoxifen) • Venlafaxine XL(SNRI) 37.5, 75, 150mg • Gabapentin • 900mg • Clonidine • 0.05-0.15mg • Others: Isoflavones • Studies are poor to good showing these are not effective more than placebo Botanicals Acupuncture • May help some women Behavioral • May provide relief when done for 20min 3xa day Beliefs about what is “Natural” • Fewer than 1 in 3 women choose • Natural= Believed to be to take conventional hormone plant derived, not treatment synthesized. Made without chemicals. • At least 36% of Americans use some form of complementary/ alternative medicine (> 60% if • Associated with fewer or prayer & megavitamins for no risks or adverse health factored in) effects. It is equally or more effective than • The media, and not women’s conventional hormone healthcare practitioners, have therapy been the primary source of information concerning hormone benefits and risks • Treats & prevents osteoporosis & has no heart disease risk • The end product, physiologic effect, should be the concern What are Bioidentical Hormones • Diosgenin extrated from • Claim to Individualize high-yield soy and Mexican therapy based on hormone yams (Dioscorea) and levels chemically converted into progesterone • Saliva tests provide poor reproducibility, lack evidence supporting the stability of samples in storage and handling, and are subject to large interassay variability. • History: 1930s the first Hormone levels in saliva may vary BH preparations were both depending on diet, time of day, the hormone being tested, and changes in natural and bioidentical, other variables such as secretion rate. they were derived from human pregnancy urine • Much of the physiological effects are determined at the cellular level and not the sera level • Estriol (biest/triest): currently component in • High failure rate of compounded progestin which is solely prescribed to protect most BHT. Considered by women from estrogen-associated effects proponents to be “gentler on endometrial tissue and protective” Table 1. Common Hormone Therapies for Relief of Menopausal Related Symptoms Generic Brand Available Strength (mg) Route of Indications Dosing Source of active FDA Bioidentical Name generic Administration ingredients approved Branded hormone therapeutics Estrogen alone Conjugated estrogens Genestin No 0.625 Oral Moderate-severe VmS Continuous Synthesized from soy and Yes No 0.9 daily yams Conjugated synthetic Enjuvia No 0.3 Oral Moderate-severe VmS Continuous Synthesized from soy and Yes No estrogens 0.45 daily Mexican yams 0.625 Yams 1.25 Conjugated estrogens Premarin No 0.3 Oral Moderate-severe VmS; moderate- Continuous Pregnant mares’ urine Yes No 0.45 severe vulval and vaginal atrophy daily 0.625 0.9 1.25 0.625 Vaginal cream Atrophic vaginitis; kraurosis vulvae Esterified estrogens Menest No 0.3 Oral Moderate-severe VmS; atrophic Continuous Synthesized from soy and Yes No (estrone, equiline) 0.625 vaginitis; kraurosis vulvae daily yams 1.25 2.5 Micronized estradiol Estrace Yes 0.5 Oral Moderate-severe VmS; Continuous Synthesized from soy Yes Yes (estrone, equiline) 1 atrophic vaginitis; kraurosis daily and yams 2 vulvae Prev.o st. Estropipate Ogen Yes 0.625 Oral Moderate-severe VmS; Continuous Synthesized from Yes Yes 1.25 moderate-severe vulvar and Mexican yams 2.5 vaginal atrophy; Prev.o st. Estropipate Ortho-Est Yes 0.625 Oral Moderate-severe VmS; Continuous Synthesized from yams Yes Yes 1.25 moderate-severe vulvar and vaginal atrophy; Prev.o st Estradiol Alora No 0.025 Transdermal Moderate-severe VmS; Continuous Synthetic? Yes Yes 0.05 patch moderate-severe vulvar and Twice weekly 0.075 vaginal atrophy; Prev.o st 0.1 Estradiol Climara No 0.025 Transdermal Moderate-severe VmS; Continuous Synthesized from soy Yes Yes 0.0375 patch moderate-severe vulvar and Once weekly 0.05 0.06 vaginal atrophy; Prev.o st 0.075 0.1 Table 1. Common Hormone Therapies for Relief of Menopausal Related Symptoms Generic Brand Available Strength (mg) Route of Indications Dosing Source of active FDA approved Bioidentical name generic administration ingredients Estradiol Estraderm No 0.05 Transdermal patch Moderate-severe Vms; Continuous Synthesized Yes Yes 1 moderate-severe vulvar twice weekly from Mexican and vaginal atrohophy; yams Prev. o st. Estradiol Estring No 2 Vaginal ring Moderate-severe vulvar Continuous q90 Synthesized Yes Yes delivers and vaginal atrhophy days from Mexican 7.5μg/day yams Estradiol Vivelle No 0.025 Transdermal Moderate-severe Vms; Continuous Synthesized Yes Yes Vivelle- 0.0375 patch moderate-severe vulvar twice weekly from Mexican Dot 0.05 and vaginal atrohophy; yams 0.075 Prev. o st. 0.1 Estradiol Femring No 0.05 Vaginal ring Moderate-severe VmS Continuous q3- Synthesized Yes Yes acetate 0.01 months from soy (prodrug converts /day to estradiol) Estradiol Femtrace No 0.45 Oral Moderate-severe VmS Continuous Synthesized Yes Yes (prodrug acetate 0.9 from soy converts to 1.8 estradiol) Estradiol Depo- Yes 1 Injection Moderate-severe VmS Continuous Synthetic? Yes Yes (prodrug cypionate Estradiol 5 (in oil) Q3-4 weeks converts to Cyclic estradiol) Estradiol Estrasorb No 8.7 Topical emulsion Moderate-severe VmS Continuous daily Synthesized Yes Yes hemihydrate (two 1.74-g pkgs) (micellar from soy deliver 0.5/day nanoparticle) Estradiol Vagifem No 0.025 Vaginal tablet Atrophic vaginitis Continuous daily Synthesized Yes Yes hemihydrate for 2 weeks from soy twice weekly after Estradiol Delestroge Yes 1 Injection (in oil) Moderate-severe VmS Continuous q4 Synthetic? Yes Yes (prodrug valerate n 5 weeks cyclic converts to estradiol) Estradiol Valergen- Yes 10 Injection (in oil) Moderate-severe VmS Continuous q4 Synthetic Yes Yes (prodrug valerate 10,20, or 40 20 weeks cyclic converts to 40 estradiol) Table 1. Common Hormone Therapies for Relief of Menopausal Related Symptoms Generic Brand name Available Strength (mg) Route of Indications Dosing Source of active FDA Bioidentical generic administration ingredients approved Etinyl estradiol Estinyl No 0.02 Oral Moderate-severe Continuous Syntehsized from soy and Yes No 0.05 VmS yams 0.5 Branded hormone therapeutics: Progestogens Medroxypro- Amen Yes 10 Oral To reduce risk of Cyclic Synthesized from soy or Yes No gesterone acetate endometrial continuous yams hyperplasia in postmenopausal Medroxypro- Cycrin Yes 2.5 Oral women who are Cyclic Synthesized from soy or Yes No gesteron acetate 5 taking estrogen continuous yams 10 and have
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