American College of Obstetricians and Gynecologists: Response to WHI

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American College of Obstetricians and
Gynecologists Response to WHI
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Overview

• Over 20 million women take hormone therapy (HT)
• Symptom relief
• 20 stay on HT more than 5 years
• Long term risks versus benefits remain unclear
  until WHI

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Overview

• WHI study is well-designed
• Appropriately powered
• Well-conducted study
• Clear hypotheses and endpoints
• Appropriately analyzed

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WHI Findings and ACOG Recommendations

• WHI demonstrated no benefit of continuous
  combined estrogen progestin on CVD
• 7 additional events per 10,000 women per year
• ACOG Continuous combined HT is no longer
  recommended for prevention of CVD and if
  prescribed for that purpose should be
  discontinued.

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WHI Findings and ACOG Recommendations

• WHI demonstrated increased breast cancer rates in
  women on continuous combined estrogen progestin
• 8 additional events per 10,000 women per year and
  is cumulative.
• The increase in breast cancer was not evident
  until year 4 of study
• Confirms observational studies
• Is this linked to the combination of the estrogen
  progestin?

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WHI Findings and ACOG Recommendations

• Women on continuous combined estrogen progestin
  had fewer fractures
• Largest fracture trial with HT
• 5 less fractures per 10,000 women per year
• Despite these findings, ACOG recommends that
  other primary preventive therapies such as
  bisphosphonates and SERMs be considered.
• HT can be considered in women at risk for
  osteoporosis and vasomotor symptoms.

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WHI Findings and ACOG Recommendations

• Rates of colorectal cancer were reduced in women
  taking combined HT.
• 6 fewer cases per 10,000 women per year
• ACOG The apparent benefit reduction in
  colorectal cancer is not sufficiently robust to
  recommend its use solely for prevention of
  colorectal cancer.

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Current Challenges for the Clinician

• Decision to use HT requires counseling and
  evaluation by the physician
• WHI was not designed to address use of HT for
  vasomotor symptoms(VMS) and cognitive benefits.
• Vasomotor symptoms are the major reason for
  younger women starting HT
• Each woman must be individually evaluated to the
  reason(s) for using HT

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Current Challenges for the Clinician

• ACOG recommends that HT for management of
  vasomotor symptoms be given for a short time with
  the lowest effective dose.
• Long term use of continuous combined estrogen
  progestin should be discontinued in asymptomatic
  patients.
• For genitourinary symptoms, alternative methods
  of estrogen delivery vaginal creams, tablets and
  rings should be considered.

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Current Challenges for the Clinician

• Patients remaining on HT should have periodic
  assessment at least annually.
• No definitive data available on HT tapering
  strategy.
• Severe VMS may require restart of HT
• Vaginal bleeding may occur in some women

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Future Challenges

• What is the generalizability of the WHI findings?
• Findings apply to 1 regimen CEE 0.625 mg/MPA 2.5
  mg
• Are these specific for MPA-containing products?
• Do norethindrone-containing combinations have
  different effects?
• For now ACOG feels that other regimens cannot be
  presumed to be safer or more effective.

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Future Challenges

• For many women who must take HT for VMS, are the
  transdermal and transvaginal routes or lower
  doses of estrogen safe and effective?
• There is a need to develop new effective
  therapies for treatment of VMS
• Short and long term effects of estrogen on
  cognitive performance and dementias remain
  unclear.
• ACOG urges that these aspects HT be pursued with
  vigor.