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Disclaimer
DISCLAIMER

  • Menopausetoday gives the following presentation for your information and to promote discussion.

  • We welcome your comments

  • We advise you if you have concerns to consult your doctor or local health department for further information.


Dr beverley lawton dr jill shepherd 18 7 2002 comment on whi study
Dr Beverley Lawton Dr Jill Shepherd 18/7/2002 comment on WHI study

  • The following is a presentation covering the results of the recent WHI study. This is designed primarily for a medical audience

  • Please feel free to send comments to us@menopasuetoday.com and discussion will be reported under book exerpt


National institutes of health nih women s health initiative whi
National Institutes of Health (NIH) WHI studyWomen’s Health Initiative (WHI)

The Results

JAMA, July 17, 2002 - Vol 288, No.3


Whi study design
WHI Study Design WHI study

Two study arms:

1. Combined HRT vs PlaceboTerminated

Conjugated equine oestrogens (0.625mg) + medroxyprogesterone acetate (2.5mg) vs placebo

2. Oestrogen vs Placebo Ongoing

Conjugated equine oestrogens (0.625mg) vs placebo


Combined hrt vs placebo study design
Combined HRT vs Placebo Study Design WHI study

  • n=16,608 women with an intact uterus

  • Age range= 50-79yrs (Average age = 63 yrs)

  • Recruited from 40 US centres between 1993-1998

  • Follow-up of 5.2 years (8.5 years planned)


Main findings
Main Findings WHI study


Composite outcomes for e p
Composite Outcomes for E+P WHI study

OutcomeHazard Ratio (95% CI)

Total Cardiovascular Disease1.22 (1.09-1.36)

Total Cancer1.03 (0.90-1.17)

Combined Fractures0.76 (0.69-0.85)

Total Mortality0.98 (0.82-1.18)

Global Index1.15 (1.03-1.28)

 No difference in mortality and no overall increase in cancers


Main findings the risks
Main Findings: the Risks WHI study

Per 10,000 women after 5 years there was an increased risk of:

  • Breast Cancer (from 30 to 38 cases)

  • Coronary Heart Disease (from 30 to 37 cases)

  • Stroke (from 21 to 29 cases)


Main findings the benefits
Main Findings: the Benefits WHI study

Per 10,000 women after 5 years there were reductions in:

  • Colorectal Cancer (from 16 to 10 cases)

  • Hip Fracture (from 15 to 10 cases)


Absolute excess risks
Absolute Excess Risks WHI study

Absolute excess risks per 10,000 person years attributable to oestrogen+progestin were:

  • 7 more CHD events

  • 8 more strokes

  • 8 more PEs

  • 8 more invasive breast cancers

    The absolute excess risk of events included in the global index was 19 per 10,000 person years


Absolute risk reductions
Absolute Risk Reductions WHI study

Absolute risk reductions per 10,000 person years attributable to oestrogen+progestin were:

  • 6 fewer colorectal cancers

  • 5 fewer hip factures


Dsmb recommendation
DSMB recommendation WHI study

  • Study terminated because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect

  • The global index statistic supported risks exceeding benefits


Study conclusions
Study Conclusions WHI study

  • Overall the health risks exceeded benefits from use of combined estrogen+progestin among healthy postmenopausal US women

  • Results indicate that this regimen should not be initiated or continued for the primary prevention of CHD


Discussion points
Discussion points WHI study

  • Significant study

  • Breast cancer “strong trend” as rates not statistically significant

  • Study stopped on breast Ca, and global trend not CHD events

  • Trial could not distinguish the effects of oestrogen from progestin


Discussion points1
Discussion points WHI study

  • Older women – average age 63 years

  • Not taking HRT for symptoms

  • Large dropout rate – 42 % HRT group and 38% of placebo

  • What is the significance of Progestin?

  • Oestrogen arm had NO increased breast cancer rate and is continuing


Disclaimer


Other issues not covered
Other issues not covered risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • Quality of life

  • Vaginal Health

  • Cognition

  • Gallbladder


Benefits of hrt
Benefits of HRT risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.


Established benefits
Established Benefits risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • Eliminates hot flushes, night sweats, dry vagina, and palpitations.

  • Reduces osteoporotic bone fracture (?P)

  • Reduces colorectal cancer (?P)


Possible benefits
Possible Benefits risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • May increase mood and feeling of well-being –quality of life

  • May reduce risk of Alzheimer’s disease

  • May reduce arthritis

  • May maintain dental health


Contraindications for hrt
Contraindications for HRT risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • Active hepatitis- acute

  • Previous DVT (?)

  • MI in the last 6 months

  • Undiagnosed vaginal bleeding


Risks of hrt
RISKS of HRT risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.


Established risks
Established Risks risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • HRT increases the risk of VTE (?P)

  • HRT increases the risk of non-fatal stroke (?P)

  • HRT increases the rate of non-fatal MI (?P).


Established risks 2
Established Risks 2 risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • Estrogen increases the risk of endometrial cancer when it is taken without a progestin.

  • HRT increases the incidence of gallbladder disease in some women


Possible risks
Possible Risks risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • There may be an increased risk of breast cancer after taking HRT for five years or more (?P)


What to say to patients
What to say to patients risk for a women for 1 year for breast cancer is less than 1tenth of a per cent.

  • The risk to individual women is small and includes a small risk in DVT, stroke, CHD.

  • No increased breast cancer risk in first 4 years of use (?P)

  • Safe and effective for symptoms

  • Effective for osteoporosis; but other medications longterm


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