Risks and Benefits of Estrogen plus Progestin in Healthy Postmenopausal Women (Women’s Health Initiative)

Overall Study Question

This study is the first randomized controlled trial to look at the long term benefit and harm of hormone replacement in healthy postmenopausal women.

Patients

16,608 women, mean age 63.  Four percent were being treated for diabetes, 36% were being treated for hypertension, 13% were being treated for elevated cholesterol and 11% were smokers.

Treatment

Women received either conjugated equine estrogen 0.625 mg PO daily PLUS medroxyprogesterone 2.5 mg PO daily or placebo.

Duration

5.2 years – the study was supposed to be 8.5 years in length but was stopped early due to health risks exceeding benefits.

Results

CHD (%) Stroke (%) DVT (%) PE
(%)
Total CVD (%) Breast Cancer (%) Colorectal cancer (%) Hip fractures (%) All fractures (%) Deaths (%) Global Index (%)
Estrogen/progestin 1.9 1.5 1.4 0.8 8.2 2.0 0.5 0.5 7.6 2.7 8.8
Placebo 1.5 1.0 0.6 0.4 6.7 1.5 0.8 0.8 9.7 2.7 7.7
Relative Risk Reduction/increase 27 50 133 100 22 33 38 38 22 NSS 14
Absolute Risk Reduction/increase 0.4 0.5 0.8 0.4 1.5 0.5 0.3 0.3 2.1 1.1
NNT/NNH over 5.2 years 250 200 125 250 67 200 333 333 48 91

Results are statistically significant using at least nominal 95% CIs – NSS = not statistically significant

CHD = coronary heart disease, DVT = deep vein thrombosis, PE = pulmonary emboilism, CVD = cardiovascular

Global index – represents the first event for each participant from among the following types – CHD, stroke, pulmonary embolism, breast cancer, endometrial cancer, colorectal cancer, hip fracture, and death due to other causes

How does this study contribute to the drug therapy of hormone replacement?

This study suggests that other than for symptom control, the harms of long-term hormone replacement outweigh the benefits.

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