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Hormone Therapy

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Title: Hormone Therapy


1
Hormone Therapy Menopause Care
  • Association of Reproductive Health Professionals
  • www.arhp.org

2
Expert Medical Advisory Committee
  • Alan Altman, MD (co-chair)
  • Linda Dominguez, NP
  • Karen Gunning, PharmD
  • Barbara Kass-Annese, NP
  • Robert Langer, MD, MPH
  • Barbara Malat, CPNP, PA-C (co-chair)
  • Joan Tilghman, RN, PhD
  • Susan Wysocki, RNC, NP

Required Slide
3
Learning Objectives
  • Identify two physiological changes associated
    with menopause
  • Identify three types of symptoms women commonly
    experience during perimenopause and menopause
  • Discuss key findings from the Womens Health
    Initiative (WHI) and how these findings should be
    applied to the treatment of menopausal women

more
4
Learning Objectives (continued)
  • Describe three effective talking points about
    menopausal therapy that help patients make
    informed decisions about hormone therapy
  • Discuss four basic differences between
    prescription hormone therapies
  • Discuss the current data on herbal hormone
    products
  • List four requisites for individualizing hormone
    therapy

5
Defining Menopause Perimenopause
A womans lifetime
NAMS. Menopause Curriculum Study Guide.
2002.Utian, WH. Menopause. 2001.
6
Two Key Physiological Changes
Gruber CJ, et al. N Eng J Med. 2002.
7
Menopause-related Symptoms
Nevin JE, Pharr ME. Prim Care. 2002.Stenchever
MA, et al. Comprehensive Gynecology, 4th ed. 2001.
8
Medical Conditions More Common After Menopause
  • Osteoporosis
  • Atherosclerotic disease

Stenchever MA, et al. Comprehensive Gynecology,
4th ed. 2001.Wenger NK. Brit Med J. 1997.
9
Fear Confusion After the WHI HERS
10
Overview of HERS
  • Heart and Estrogen/progestin Replacement Study
    (HERS)
  • Secondary prevention in women with CHD
  • Found CEE with MPA does not reduce MIs
  • More CHD events in hormone group during Year 1

Coope J. Management of the Menopause and
Post-Menopausal Years. 1976. Baumgardner SB, et
al. Obstet Gynecol. 1978. Stampfer MJ, et al. N
Engl J Med. 1985. Wilson PWF, et al. N Engl J
Med. 1985. Hulley S, et al. JAMA. 1998.
11
Overview of WHI
  • Womens Health Initiative (WHI )
  • Primary prevention in healthy women
  • Age 50-79 (mean 63 y)
  • Post-menopause (mean 12 y)
  • Treated with CEE with (or without) MPA
  • Primary outcome rate of fatal or non-fatal MI
  • E-P arm terminated July 2002
  • E-only arm terminated March 2004

Rossouw JE, et al. JAMA. 2002. Anderson GL.
Press conference remarks. 2004.
12
Understanding WHI Results
13
WHI Results CHD
Manson JE, et al. N Engl J Med. 2003. WHI
Steering Committee. JAMA. 2004. Pradham AD, et
al. JAMA. 2002.
14
WHI Results Breast Cancer
Chlebowski, RT. JAMA. 2003.WHI Steering
Committee. JAMA. 2004.
15
WHI Results VTE
Rossouw JE, et al. JAMA. 2002.WHI Steering
Committee. JAMA. 2004.
16
WHI Results Stroke
Wassertheil-Smoller S, et al. JAMA. 2003.WHI
Steering Committee. JAMA. 2004.
17
WHI Results Osteoporotic Fractures
Cauley, JA. JAMA. 2003.WHI Steering Committee.
JAMA. 2004.
18
WHI Results Colorectal Cancer
Chlebowski RT, et al. N Engl J Med. 2004.WHI
Steering Committee. JAMA. 2004.
19
WHI Results Quality of Life
Hays J, et al. N Engl J Med. 2003.
20
WHI Results Gynecologic Cancers
Anderson GL, et al. JAMA. 2003.
21
WHI Results Dementia
Rapp SR, et al. JAMA. 2003. Shumaker SA, et al.
JAMA. 2003.NIH. 2004.
22
Understanding WHI Results
  • What WHI results do not tell us
  • Benefits and risks of beginning HT at menopause
  • Benefits and risks for treatment of
    menopause-related symptoms
  • Use of other doses, formulations, regimens,
    durations, and routes of administration of HT
  • Information on events after cessation

23
Putting WHI Results into Context
  • Well-designed study of mostly asymptomatic women
    distant from menopause
  • Results have been generalized to other groups and
    to other HT formulations
  • Not yet known if findings apply

Lobo RA. Arch Intern Med. 2004.
24
Translating Results into Clinical Practice
Oral hormone therapy post-menopausal women
25
ACOG Guidelines
ACOG. 2004.
26
NAMS Guidelines
North American Menopause Society. Menopause. 2003.
27
NPWH Guidelines
Nurse Practitioners in Womens Health. 2004.
28
FDA Guidelines
Food and Drug Administration. 2004.
29
Counseling Patients About HT
  • Each woman must weigh risks and benefits in light
    of her circumstances
  • Women must put risks into perspective to make
    fully informed decision
  • Each woman must clarify her purpose and goal for
    using HT

30
Contraindications to Systemic ET
  • Pregnancy
  • VTE
  • Breast cancer
  • Estrogen-sensitive cancers
  • Liver disease
  • Hypertriglyceridemia

31
Weighing Risks and Benefits
32
Understanding Risk
  • WHI 26 increase in breast cancer in E-P arm
  • This does not mean 26 chance of getting breast
    cancer

International Food Information Council. 2004.
Nurse Practitioners in Womens Health. 2004.
Rossouw JE, et al. JAMA. 2002.
33
Absolute Risk Quantified by WHI
WHI. June 2002 HRT Update. 2002.
34
Absolute Risk Quantified by WHI
Huang Z. JAMA. 1997. LaCroix AZ. Lancet.
1997. Longnecker MP. Cancer Epidemiol Biomarkers
Prev. 1995. Smith-Warner SA. JAMA. 1998. Thune
I. N Engl J Med. 1997. WHI. 2002.
35
Relative Risk of Breast Cancer
Collaborative Group on Hormonal Factors in Breast
Cancer. Lancet. 1997.
36
Clarifying Goals or Purpose
  • Risk/benefit ratio varies based on goals

What is most important among your
menopause-related health concerns?
Why do you want to start/continue HT?
37
Individualizing Hormone Therapy
  • Requires
  • Familiarity
  • Understanding how to help a woman find the best
    product and regimen

38
Types of HT Estrogens
39
Types of HT Progestogens
Adams MR, et al. Arteriosclerosis. 1990. Adams
MR, et al. Arterioscler Thromb Vasc Biol. 1997.
Espeland MA, et al. J Clin Endocrinol Metab.
1997. NAMS. 2002. Williams JK, et al. J Am
Coll Cardiol. 1994.
40
Types of HT Progestogens
NAMS. Menopause. 2003. King RJ, Whitehead MI.
Fertil Steril. 1986.PEPI Investigators. JAMA.
1995.
41
Progestogens Possible Side Effects
  • Swelling and breast pain more common with MPA
  • Acne and hirsutism more common with
    levonorgestrel and norethinedrone
  • Dizziness and fatigue associated with high-dose
    progesterone
  • Metabolic effects differ

NAMS. Menopause. 2003. Mitchell JL, et al. Prim
Care. 2003.PEPI Investigators. JAMA. 1995.
42
Routes of Administration
Oral
Transdermal
Vaginal
Slater CC, et al. Menopause. 2001.
43
Routes of Administration Differences
  • Systemic vs. local effects
  • Even vs. uneven blood levels
  • First-pass metabolism or not
  • Hemostatic effects or not
  • Risk of VTE
  • Effects on procoagulants and lipids
  • Need for concomitant progestogen

Vongpatanasin W. J Am Coll Cardiol. 2003.
Decensi A. Circulation. 2002. Scarabin PY.
Lancet. 2003. Femring package insert. 2003.
Hemelaar M. Menopause. 2003.
44
Compounding Pharmacies
45
Regimens
46
Oral Therapies
47
Oral Therapies
48
Transdermal (Patches and Gel)
49
Vaginal Creams, Tablets, and Gels
Not labeled by the FDA for menopause-related
symptoms
50
Vaginal Rings and IUS
LocalSystemicIntrauterine Mirena is not
labeled by the FDA for menopause-related symptoms
Femring package insert. 2003.
51
Herbal Products for Menopause Relief
Carroll DG. Am Fam Physician. 2006. Ma J,
Drieling R, Stafford RS. Menopause. 2006.
52
Herbal Products Do They Work?
  • Black cohosh
  • Red clover
  • Dong quai
  • Soy
  • Evening primrose seed oil

Carroll DG. Am Fam Physician. 2006. Low Dog T.
Am J Med. 2005. NIH/NCAM. 2005. Newton KM, et
al. Ann Intern Med. 2006. Pockaj BA, et al. J
Clin Oncol. 2006.
53
Androgens
  • Estratest and Estratest HS indicated for
    vasomotor symptoms if estrogen alone ineffective
  • Testosterone has also been used to improve sexual
    function
  • Not FDA-approved for this use

OBGYN.net. 2003. Estratest and Estratest HS
package insert. 2004.
54
Selective Estrogen Receptor Modulators
  • Mediate effects through estrogen receptor binding
  • Activate certain estrogenic pathways and block
    others
  • Not indicated for menopause-related symptoms
  • Can cause hot flashes from estrogen receptor
    blockade

Evista package insert. 2001.
55
Requirements of Individualized Care
  • Gathering specific health-related information
  • Providing accurate, patient-specific HT
    information
  • Supporting informed decision making
  • Addressing ongoing health needs

56
Case 1 Mary S.
  • Final menstrual period 18 months ago at age 49
  • Healthy with no CHD risk factors
  • Hot flashes daily
  • Herbal remedies not helping
  • Terrified of those hormone drugs

57
Case 1Recommended Management
  • Symptomatic with no contraindication
  • Candidate for systemic HT, not local HT
  • To decide on route, consider her preference,
    medical history, other factors
  • Progestogen needed if oral, transdermal, or
    systemic vaginal therapy is chosen

58
Case 2 Zelda K.
  • 60 years old
  • 8 years postmenopausal
  • Has never taken HT
  • Severe dyspareunia, urinary urgency, and
    frequency X 1 year
  • Does not want oral HT, because friend had DVT on
    it

59
Case 2Recommended Management
  • Severe genitourinary symptoms
  • No vasomotor symptoms
  • Candidate for vaginal estrogen
  • Could use cream, tablet, or locally acting ring
    (Estring)

60
Case 3 Ann P.
  • 56 years old
  • Was taking oral HT for
    vasomotor symptoms
  • Internist told her to stop HT
  • Off HT several months
  • Vasomotor symptoms
    gone but sexual desire low
  • Wants to restart HT
  • No contraindications to systemic HT

61
Case 3Recommended Management
  • Provider should ask about sexual function,
    relationship, and pharmacological issues to
    clarify cause
  • Low sexual desire may be related to low hormone
    levels
  • May be candidate for restarting HT, possibly with
    androgen

62
Case 4 Terri O.
  • 48 years old
  • Perimenopausal
  • Menses generally regular
  • Experiencing hot flashes, mood swings, and
    fatigue
  • Requests HT
  • Had DVT on oral contraceptive at age 35
  • No other medical problems

63
Case 4Recommended Management
  • HT should not be used during perimenopause
  • OCs contraindicated
  • Could use estrogen augmentation with patch
  • Does not need progestogen menses still regular
  • Needs progestogen challenge if no menses X 3
    months
  • Before any form of HT is started, possibility of
    pregnancy should be investigated, as appropriate

64
Case 5 Katherine W.
  • 54 years old
  • Post hysterectomy
    without oophorectomy
  • Recent severe vasomotor
    symptoms and forgetfulness
  • Afraid of HT
  • Family physician told her recent
    studies showed HT causes breast cancer
  • Healthy, no contraindications to HT

65
Case 5Recommended Management
  • Candidate for oral or non-oral
    systemic HT
  • Does not need progestogen
  • Provider should educate about actual risks
    associated with HT
  • HT could be used for a short time, then gradually
    reduced to avoid estrogen withdrawal symptoms

66
Case 6 Debra R.
  • 58 years old
  • Has taken oral HT for 4 years
  • Vasomotor symptoms and vaginal dryness have
    returned over past 3 months

67
Case 6Recommended Management
  • If adherence not an issue, relapse likely because
    of increased SHBG caused by oral estrogen
  • Options include adding androgen or changing to
    non-oral estrogen

68
Recommendations for Further Study
  • HT using other routes of administration, hormone
    components, and regimens
  • Comparison of bio-identical products
  • Use of androgens alone or with HT
  • Factors that affect patient adherence
  • How patients make decisions about HT
  • Optimal regimens for discontinuing HT

69
Summary
  • Patients and providers have been confused about
    HT as a result of the WHI and HERS data
  • Understanding study results and limitations helps
    providers counsel women to make informed
    decisions about HT
  • Individualization of therapy is essential for
    women who decide to use HT
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