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Starting and Stopping Hormone Therapy

Starting and Stopping Hormone Therapy. Marcelle I. Cedars, MD Director, Division of Reproductive Endocrinology University of California, San Francisco Women’s Health—Mount Zion San Francisco, California. “Yes” Most effective treatment strategy available for vasomotor symptoms Known risks.

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Starting and Stopping Hormone Therapy

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  1. Starting and StoppingHormone Therapy Marcelle I. Cedars, MDDirector,Division of Reproductive EndocrinologyUniversity of California, San FranciscoWomen’s Health—Mount ZionSan Francisco, California

  2. “Yes” Most effective treatment strategy available forvasomotor symptoms Known risks “No” Risks outweigh benefits No risk is acceptable Should Symptomatic Women Be Offered Hormone Therapy?

  3. Population Management vs Individual Care Concerns CVD = cardiovascular disease; WHI = Women’s Health Initiative. 1. [No Author]. JAMA. 2002;288:321.

  4. Vasomotor Symptoms • Common complaint • Negatively impact quality of life • Typically abate within 2–3 years • Most clearly linked to hormonal changes • Most common indication for initiation of hormone therapy

  5. Additional Problems Associated with Menopause • Vulvar and vaginal atrophy • Postmenopausal osteoporosis • Sleeping difficulties • Alterations in mood (?) • Alterations in cognition (?)

  6. Vasomotor SymptomsEpidemiology • Study of Women’s Health Across the Nation (SWAN) (2000) • 16,000+ women aged 40–55 years • >50% of late perimenopausal study patients experienced symptoms • Impact of socioeconomic status, race/ethnicity, body mass index, smoking status, and physical activity Gold EB, et al. Am J Epidemiol. 2000;152:463.

  7. Vasomotor SymptomsEpidemiology • Review of published longitudinal studies (2005) • Prevalence throughout the transition • Late reproductive stage, 6%–13% • Early to late menopausal stages, 4%–46% • Late menopausal transition, 33%–63% • Postmenopause, 79% Woods MF, et al. Am J Med. 2005;118:14.

  8. Vasomotor SymptomsWhen Is It Appropriate To Prescribe? • Clinical decision-making = best available evidence + clinical judgment + patient education • Balance between population statistics and individual patient fears and symptoms • >97% of women in WHI had no negative impact from hormone therapy1 • Most appropriate use with least controversy • Generally healthy women for short-term relief of intolerable menopausal symptoms • Lowest dose for shortest duration 1. NIH. WHI HT Update–2002. Available at: http://www.nhlbi.nih.gov/health/women/upd2002.htm.

  9. Starting and Stopping Hormone Therapy • The need • Symptomatic patients with few effective alternatives • The problem • Lack of high-quality data • What to do? • The importance of individualization

  10. Starting and Stopping Hormone TherapyPremature Ovarian Failure • Early menopausea should not be accorded the same concerns asage-appropriate hormonal changes • Limitation to 5 years (or any presettime frame) is artificial • Benefits largely outweigh the risks aPrior to 40 years of age.

  11. Starting Hormone TherapyLate Reproductive Years/Early Transition • Potential problems (still cycling) • Abnormal bleeding (heavy, irregular) • Vasomotor symptoms • Vaginal dryness • Increasing “PMS” PMS = premenstrual syndrome.

  12. Starting Hormone TherapyLate Reproductive Years/Early Transition • Route of administration • ? impact on specific symptoms • Mood and headache may benefit from transdermal (continuous dosing) • Dosing • Additional goal of suppressing endogenous cycles and mimic of circulating levels • Transverse menstrual cycle mean: approximately100 pg/mL • Cyclic vs continuous • Side-effect profile in cycling women with combined continuous dosing

  13. Starting Hormone TherapyMid-to-Late Transition Through Postmenopause • Problems (largely not cycling) • Vasomotor symptoms • Vaginal dryness • Urinary symptoms

  14. Starting Hormone TherapyMid-to-Late Transition Through Postmenopause • Route of administration • Patient preference • Mood and headache may benefit from transdermal (continuous dosing) • Vulvo-vaginal symptoms – importance of local • Dosing • Lowest effective dose • Cyclic vs continuous • Patient preference for cycles • Information regarding higher breast cancer risk with continuous progestin1 • Alternative progestin dosing/route of administration 1. Heiss G, et al. JAMA. 2008;299:1036.

  15. Stopping Hormone Therapy • Stopping (by choice) after12 months of starting • 62% older women (≥65 years) • 48% younger women (50–55 years) • Reason: vaginal bleeding Ettinger B, et al. Menopause. 1999;6:282.

  16. Stopping Hormone TherapyPredictors of Difficulty Stopping • Telephone interviews of Kaiser population • Women aged 50–69 years who took hormone therapy ≥1 year (N = 377) • 74% successfully stopped • 26% resumed treatment • Troublesome withdrawal symptoms • Hysterectomy • Hormone therapy from a nongynecologist • Perceived higher risk for fracture Grady D, et al. Obstet Gynecol. 2003;102:1233.

  17. Stopping Hormone TherapyWithdrawal Symptoms • Symptoms after stopping hormone therapyin Kaiser-population study • 70% reported no/minimal symptoms • 30% reported troublesome symptoms • 62% of women unable to stop treatment • 19% of those who successfully quit Grady D, et al. Obstet Gynecol. 2003;102:1233.

  18. Stopping Hormone TherapyLikelihood of Discontinuation • Telephone interview of community sample • 533 women aged 45–54 years (N = 533) • Factors related to discontinuationof hormone therapy • Increased understanding of risks/benefits • Confidence • Mental health symptoms • History of gynecologic surgery • Perception that menopause is natural Bosworth HB, et al. J Behav Med. 2005;28:105.

  19. Stopping Hormone TherapyTaper vs Abrupt Cessation • Randomized controlled trial (N = 91) • Reappearance of vasomotor symptoms • <3 months after discontinuing therapy • Less-severe symptoms with taper cessation • At 6 months • Less-severe symptoms with abrupt cessation • At 9–12 months • No difference in symptoms between taper or abrupt cessation • Similar percentage in each groupresumed treatment Haimov-Kochman R, et al. Menopause. 2006;13:370.

  20. Stopping Hormone TherapyTaper vs Abrupt Cessation • Taper vs abrupt cessation may not affect recurrence of symptoms1 • Taper may allow titration to lowest effective dosing2 • Taper may allow individualized slow, long taper (hold at dose where symptoms recur then attempt taper again after stabilized)3 1. Aslan E, et al. Maturitas. 2007;56:78. 2. Haimov-Kochman R, et al. Menopause. 2006;13:370.3. Grady D. Menopause. 2006;13:323.

  21. Conclusions • Individualization is important • Quality of life issues are important but should be weighed against an individual patient’s health risk1 • Risks are small, but when an event occurs, impact on personal QALE is significant • Severity of symptoms weighed against CVD risk • Continued treatment should be reviewed annually QALE = quality-adjusted life expectancy; CVD = cardiovascular disease. 1. Col NF, et al. Arch Intern Med. 1004;164:1634.

  22. Brief Q & A

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