What’s in store for hormone use in women?

About 6 million women in the United States are taking the hormones estrogen plus progestin for a variety of reasons, including relief of menopausal symptoms because their health care provider advised it or for long-term health. With the news of the cessation of the Women’s Health Initiative’s (WHI) study of the two drugs,1 what is the impact on the use of such hormones?

Look for the following trends in hormone replacement therapy (HRT) use, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center in Jacksonville:

  • Fewer women will opt to use combination HRT.
  • When combination HRT is prescribed, there may be an increased emphasis on prescribing regimens formulated with progestins other than medroxyprogesterone acetate, such as norethindrone acetate or norgestimate.
  • When combination HRT is prescribed, clinicians and women increasingly will focus on lower doses of estrogens and progestins.
  • Combination HRT will be used for shorter durations — five years or less.
  • Providers will reach unequivocal recognition that combination HRT is neither indicated for treating or preventing cardiovascular disease.
  • Use of combination HRT will be more limited to the treatment of vasomotor symptoms, with less use of HRT for prevention and treatment of osteoporosis.
  • Use of bisphosphonates and raloxifene will increase for prevention/treatment of osteoporosis. (Get more information on alternatives to estrogen for osteoporosis prevention in the article "Osteo-porosis: Stop the bone robber’" see the June 2000 Contraceptive Technology Update, p. 71.)

Review the options

The WHI trial used one form of HRT: conjugated equine estrogens (0.625 mg/day CEE) and medroxyprogesterone acetate (2.5 mg/day MPA), marketed as Prempro by Wyeth Pharmaceuticals, Collegeville, PA.

A survey of doctors taken three days after the results of the WHI study were released found that Wyeth drug representatives quadrupled the number of provider visits for the drug compared with the number during the three previous weeks. Prempro accounts for nearly $1 billion of annual sales for the company.2 According to a separate analysis, Prempro prescriptions dropped about 30% in the two days after the study data were announced, relative to the average number of prescriptions written during the 20 days prior to the news.2

It is important to remember that the WHI trial only looked at one formulation; the results may not necessarily apply to lower CEE/MPA doses, other oral estrogens and progestins, or to transdermal estrogens and progestins, says Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health (NPWH). More studies are needed on other combination therapies, as well as doses and regimens, she states.

Women who wish to consider alternatives to HRT may want to consider suggestions from the Cleveland-based North American Menopause Society.3 For hot flashes, women may choose to make lifestyle changes, such as avoiding spicy foods and alcohol. Adding soy-based foods or supplementing with black cohosh may prove beneficial. Vaginal dryness may be addressed with vaginal lubricants, or women may consider use of estrogen, applied vaginally in a cream, tablet, or ring form. Women who are not at risk for osteoporosis should supplement their diets with calcium and vitamin D; those at risk should use vitamin supplementation, as well as a bone drug, the society advises.

With concerns about the estrogen/progestin HRT regimen, will women be hesitant about using other forms of hormonal preparations, including oral contraceptives?

"The data from the WHI trial are not applicable in any way that I am aware of to oral contraceptive users," says David Archer, MD, professor of obstetrics and gynecology and director of the Clinical Research Center at the Eastern Virginia Medical School in Norfolk.

Some women, having heard new concerns related to breast cancer and menopausal hormone therapy, may worry about breast cancer risks and use of hormonal contraception, notes Kaunitz.

Recently published data from the Women’s Contraceptive and Reproductive Experiences Study provide a high level of reassurance that use of combination OCs does not increase breast cancer risk,4 states Kaunitz. As to progestin/breast cancer risk, data published by the Geneva-based World Health Organization and information have been reassuring regarding injectable progestin-only contraception use,5 he notes.

"I have no doubt that people are going to continue to be confused about the role of pills and breast cancer," says Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. Help women gain assurance about the safe use of pills by reviewing the recent data from the new study, as well as directing them to the Managing Contraception web site, www.managingcontraception.com, for a thorough answer on the question, "Do birth control pills cause breast cancer?" (See the article "No link found between OCs and breast cancer" on p. 103 in this issue. To view the answer to "Do birth control pills cause breast cancer?" go to www.managingcontraception.com, click on "questions," then search on "breast cancer." Click on the question to see the response.)

References

1. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002; 288:321-333.

2. Winslow R, Hensley S. Wyeth Sales Team Calls on Doctors After Study. The Wall Street Journal, Jul 17, 2002; D3.

3. North American Menopause Society. Alternatives to Hormone Replacement Therapy: Suggestions from The North American Menopause Society. Accessed at: www.menopause.org/alternatives_hrt.html.

4. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med 2002; 346:2,025-2,032.

5. World Health Organization Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depo-medroxyprogesterone acetate: A multinational study. Lancet 1991; 338:833-838.