December 1, 2005Biometrics
Discussion on "Statistical Issues Arising in the Women's Health Initiative"
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Discussion
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Implication
Randomized trial finds increased coronary heart disease risk with estrogen plus progestin in postmenopausal women, contrasting prior observational studies.
Key Points
- To discuss statistical discrepancies between randomized trial results from the Women's Health Initiative and prior observational cohort studies regarding hormone therapy and cardiovascular risk.
- Evaluated the Women's Health Initiative trial where postmenopausal women were randomly assigned to receive either estrogen plus progestin or placebo.
- Compared randomized trial outcomes with evidence from large observational cohorts, including the Nurses' Health Study and the General Practice Research Database.
- The rate of coronary heart disease in the estrogen plus progestin group was 1.24 times (95% CI: 0.97 to 1.60) that observed in the placebo group.
- The observed elevation in coronary heart disease risk directly conflicted with earlier observational studies that had reported a reduced risk among postmenopausal hormone users.
Cite This Study
Hernán et al. (2005) studied this question.