women’s health initiative: trial of estrogen plus progestin
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Women’s Health Initiative: Trial of Estrogen plus Progestin. 16,608 women randomized Conjugated equine estrogens 0.625 mg/d + medroxyprogesterone acetate 2.5 mg/d vs. placebo Primary outcome: nonfatal MI or CHD death Primary adverse outcome: breast cancer - PowerPoint PPT PresentationTRANSCRIPT
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
Women’s Health Initiative: Women’s Health Initiative: Trial of Estrogen plus ProgestinTrial of Estrogen plus Progestin
16,608 women randomized16,608 women randomized
Conjugated equine estrogens 0.625 mg/d + Conjugated equine estrogens 0.625 mg/d + medroxyprogesterone acetate 2.5 mg/d vs. medroxyprogesterone acetate 2.5 mg/d vs. placeboplacebo
Primary outcome: nonfatal MI or CHD deathPrimary outcome: nonfatal MI or CHD death
Primary adverse outcome: breast cancerPrimary adverse outcome: breast cancer
Stopped early (mean follow-up 5.2 years) Stopped early (mean follow-up 5.2 years) because health risks exceeded benefitsbecause health risks exceeded benefits
Writing Group for the WHI Investigators. Writing Group for the WHI Investigators. JAMAJAMA 2002;288:321-333. 2002;288:321-333.
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
*1st event: CHD; stroke; pulmonary embolism; breast, endometrial, *1st event: CHD; stroke; pulmonary embolism; breast, endometrial, or colorectal cancer; hip fracture, or death due to other causesor colorectal cancer; hip fracture, or death due to other causes
Risks and Benefits of Estrogen/Progestin Risks and Benefits of Estrogen/Progestin on Clinical Outcomes: on Clinical Outcomes: Women’s Health InitiativeWomen’s Health Initiative
OutcomeOutcomeHazard Hazard RatioRatio
Nominal Nominal 95% CI95% CI
Adjusted Adjusted 95% CI95% CI
CHD (MI, coronary death)CHD (MI, coronary death) 1.291.29 1.02–1.631.02–1.63 0.85–1.970.85–1.97
CABG/PTCACABG/PTCA 1.041.04 0.84–1.280.84–1.28 0.71–1.510.71–1.51
StrokeStroke 1.411.41 1.07–1.851.07–1.85 0.86–2.310.86–2.31
Venous thromboembolic diseaseVenous thromboembolic disease 2.112.11 1.58–2.821.58–2.82 1.26–3.551.26–3.55
Total CVDTotal CVD 1.221.22 1.09–1.361.09–1.36 1.00–1.491.00–1.49
CancerCancer 1.031.03 0.90–1.170.90–1.17 0.86–1.220.86–1.22
FracturesFractures 0.760.76 0.69–0.850.69–0.85 0.63–0.920.63–0.92
DeathDeath 0.980.98 0.82–1.180.82–1.18 0.70–1.370.70–1.37
Global index*Global index* 1.151.15 1.031.03––1.281.28 0.950.95––1.391.39
Writing Group for the WHI Investigators. Writing Group for the WHI Investigators. JAMAJAMA 2002;288:321-333. 2002;288:321-333.
Slide Source:Lipids Online Slide Librarywww.lipidsonline.org
Absolute Excess Risks and Absolute Risk Absolute Excess Risks and Absolute Risk Reductions per 10,000 Person-Years: Reductions per 10,000 Person-Years: Women’s Health InitiativeWomen’s Health Initiative
Difference in risk per 10,000 person-years
CHD events +7
Strokes +8
Pulmonary embolisms +8
Invasive breast cancer +8
Colorectal cancers –6
Hip fractures –5
Global index +19
Writing Group for the WHI Investigators. Writing Group for the WHI Investigators. JAMAJAMA 2002;288:321-333. 2002;288:321-333.