# Presentation: 167815

## American College of Obstetricians and Gynecologists: Response to WHI

## 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

## Overview

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

## 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.

## 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?

## 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.

## 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.

## 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

## 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.

## 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

## 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.

## 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.