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![Page 1: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/1.jpg)
![Page 2: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/2.jpg)
Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report
Richard Santen, MD
University of Virginia
12/2/11
![Page 3: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/3.jpg)
Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report
• What have we learned?
• How should the public be informed?
• What should a post-menopausal woman do, based on what we now know?
![Page 4: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/4.jpg)
WHI
• First report 2002• Two arms
– Placebo versus conjugated equine estrogen plus MPA (E+P)
– Placebo versus conjugated equine estrogen alone (E)
• 80% reduction in menopausal hormone use over the next five years
![Page 5: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/5.jpg)
WHI 10 years later:key conclusions after a decade of reflection
• Need to consider all information based on excess risk and benefit and not relative risk and benefit
• Only women just entering menopause are candidates for menopausal hormone therapy
![Page 6: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/6.jpg)
Initial WHI Report 2002major finding
26% increasein risk of breast cancer
![Page 7: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/7.jpg)
Do I have a 26% chance of getting breast cancer since I have taken hormones for more than 5 years? That is a
one in four chance. Is this really true?
My wife immediately asked me
![Page 8: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/8.jpg)
My answer No, the 26% increase represents only relative risk.
Her reply What does that mean for me?
![Page 9: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/9.jpg)
Important Issue
• We need to distinguish between: –relative risk –absolute risk –excess risk
![Page 10: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/10.jpg)
This is how I explain this to my wife
![Page 11: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/11.jpg)
One Million Women who marched in Washington
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120,000 of these women or 12% will develop breast cancer in their lifetimes
This is absolute risk
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12,000 or 1% will develop breast cancer in five years
Absolute risk
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Lets consider just 1000 of these marchers
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How many of these women will get breast cancer within five years?
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18 Women not receiving MHT will develop breast cancer over a five year period
Absolute risk
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26% increase in relative risk in WHI
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If these 1000 women take MHT for five years,
22 women will develop breast cancer
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18 with breast cancer without MHT22 with breast cancer with MHT
Excess risk 4
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My Answer: Based on the WHI study, you will only have a 4 in 1000 chance of getting a breast cancer
that you would not otherwise have gotten if you take MHT for 5 years
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WHI 10 years later
• Relative risk is only important when absolute risk is high
• Example from common experience
![Page 22: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/22.jpg)
Example of relative vs absolute risk
• If you take one plane flight your chances of crashing are one in ten million (absolute risk)
• Your relative risk of crashing is increased by 500% if you take five plane flights .
• Your excess risk by taking five flights rather than one is four per ten million
• Bottom line: relative risk means little when absolute risk is low• This is the reason to convert all WHI data to excess risk or
benefit
![Page 23: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/23.jpg)
WHI 10 years later
• Need to consider all risk and benefit data consistently
• The Endocrine Society has expressed all risks and benefits as the number of women per 1000 using MHT for 5 years who will experience event
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What are the major excess risks reported in the original WHI study?
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WHI Estrogen plus Progestin MHT
Excess Risks
# w
omen
/1,0
00/5
yrs
0
2
4
6
8
10 E+P
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Risks
Benefits
WHI E+P
Average age 63
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What are the under-reported benefits?
![Page 28: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/28.jpg)
Reduction in Mortality
![Page 29: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/29.jpg)
Under-reported Benefits (WHI)#
pre
vent
ion
/1,0
00
/5 y
rs
0
5
10
15
20
25
30EE+P
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Timing HypothesisEarly vs. late treatment
Early Late5
4
3
2
1
0
5
4
3
2
1
EE+P
EE+P
5
4
3
2
1
0
5
4
3
2
1
![Page 31: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/31.jpg)
Timing HypothesisEarly vs. late treatment
Early Late
4
2
0
6
4
2
8
6
8
EE+P
4
2
0
6
4
2
8
6
8EE+P
![Page 32: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/32.jpg)
VTE and Stroke
Similar relative increase in risk but younger women experience these problems less commonly
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MHT 10 years after WHIonly used at start of menopause
RisksBenefits
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For Some in Menopause, Hormones May Be Only Option
By TARA PARKER-POPE
New York TimesAugust 15, 2011
![Page 35: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/35.jpg)
![Page 36: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/36.jpg)
MHT 10 years after WHIwomen with severe symptoms
Risks
Benefits
![Page 37: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/37.jpg)
What to do about breast cancer risk?
![Page 38: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/38.jpg)
Benefit
Low risk of breast cancer
Risk
High risk of breast cancer
![Page 39: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/39.jpg)
Assess risk of breast cancer and only treat those at low risk
• Low risk (i.e. 0.5% chance of breast cancer in 5 year) excess risk is 2.5/1000 per 5 years
• High risk (i.e. 4% chance of breast cancer in 5 years) excess risk 20/1000/5 years
![Page 40: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/40.jpg)
RR
Estrogen Related Risk Factors
0
1
2
3
4
5
6Bre
ast
Den
sity
Breast Cancer Risk Factors by Group
Plas
ma
E2Age
at
Men
opau
seAge
at
1st L
ive
birt
h
BM
IAge
at
Men
arch
e
MH
T
![Page 41: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/41.jpg)
RR
Estrogen Related Risk Factors
0
1
2
3
4
5
6Other Risk
FactorsBre
ast
Den
sity
Plas
ma
E2Age
at
Men
opau
seAge
at
1st L
ive
birt
h
BM
IAge
at
Men
arch
e
MH
T1
o Rel
ativ
e2
o Rel
ativ
e
Alc
ohol
Breast Cancer Risk Factors by Group
![Page 42: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/42.jpg)
Calculation of Breast Cancer Risk
• Gail Model (http://www.cancer.gov/bcrisktoolmobile)
• Tyrer-Cuzick Model (http://pulsescreening.co.uk/Corporate/Breast_cancer_prediction_model-1.pdf)
![Page 43: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/43.jpg)
For Some in Menopause, Hormones May Be Only Option
By TARA PARKER-POPE
New York TimesAugust 15, 2011
![Page 44: Tenth Anniversary of Initial Women’s Health Initiative (WHI) Report Richard Santen, MD University of Virginia 12/2/11.](https://reader036.fdocuments.net/reader036/viewer/2022062314/56649ddf5503460f94ad8331/html5/thumbnails/44.jpg)
WHI after 10 years
The Ultimate Goal is to provide the most benefit
to the patient while avoiding the most risks