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The Other Shoe Drops: New WHI Analysis

Unfavorable balance of risks and benefits also applies to women who initiated HT within 5 years after menopause.

Results of the Women's Health Initiative (WHI) showed that postmenopausal hormone therapy with conjugated equine estrogens alone or plus medroxyprogesterone acetate did not lower risk for coronary heart disease (CHD) and, overall, had an adverse risk-benefit profile (JW Womens Health Jul 31 2008). However, most WHI participants were >5 years past menopause, which might be too late to benefit from HT's potentially cardioprotective properties. Now, WHI researchers have reexamined the data to determine the effects of initiating HT within the first 5 years after menopause. Participants were from the estrogen clinical trial, an observational subcohort that had undergone hysterectomy prior to enrollment, the estrogen/progestin clinical trial, and an observational subcohort with intact uteri at enrollment. Ages at menopause and first HT use were known for all women; none had histories of breast cancer.

Most women who began HT <5 years after menopause did so before WHI enrollment. Both estrogen-alone HT and estrogen/progestin HT adversely affected risk for CHD, stroke, and venous thromboembolism, regardless of whether they were initiated <5 years or 5 years after menopause. Women who initiated either regimen within 5 years after menopause had substantially higher risk for invasive breast cancer than did those who initiated HT later. The authors caution that the results might have been influenced by the nature and duration of HT use prior to WHI study entry but, overall, concluded that the unfavorable risk-benefit balance for combined HT users and the lack of benefit for estrogen-only users apply to participants who started HT within 5 years after menopause.

Comment: Clinicians who have been awaiting guidance about risks and benefits of initiating postmenopausal HT early now have an answer: The latest WHI analysis provides little support for the hypothesis that such timing could have favorable effects. Why do these findings differ from those of previous reports (JW Womens Health May 3 2007)? One important difference is that this analysis centers around time between menopause and first use of HT, whereas earlier studies focused on time between menopause and study entry; therefore, prior HT use now assumes a more important role in driving the conclusions. Editorialists note that these new results constitute the best available evidence and that further data will be difficult to obtain; thus, these findings must guide clinical practice with respect to use of oral conjugated equine estrogens and medroxyprogesterone acetate in menopausal women. The current guidelines of professional organizations (JW Womens Health Jul 31 2008), the FDA, and similar international organizations seem the most prudent: HT generally should be used by well-informed and well-monitored patients for menopausal symptoms only, in the lowest possible doses, and for the shortest amount of time that results in symptomatic relief.

— Diane E. Judge, APN/CNP

Published in Journal Watch Women's Health August 6, 2009

Citation(s):

Prentice RL et al. Benefits and risks of postmenopausal hormone therapy when it is initiated soon after menopause. Am J Epidemiol 2009 Jul 1; 170:12.

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• Medline abstract (Free)

Banks E and Canfell K. Invited commentary: Hormone therapy risks and benefits — The Women's Health Initiative findings and the postmenopausal estrogen timing hypothesis. Am J Epidemiol 2009 Jul 1; 170:24.

• Original article (Subscription may be required)
• Medline abstract (Free)

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• WHI FOOT DROPS REPLACED WITH POINTED BOOT
  THOMAS GLEESON, 14 Aug 2009 11:01 AM EST
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