Heiss G et al. – The increased cardiovascular risks with conjugated equine estrogens (CEEs)+medroxyprogesterone acetate (MPA) during intervention were not observed post-intervention; greater risk of fatal and nonfatal malignancies occurred post-intervention in the CEE plus MPA group, and the global risk index was 12% higher in women randomized to CEE+MPA vs placebo Methods
Study to report health outcomes at 3 years after stopping intervention
Intervention phase: multi-center, double-blind, placebo-controlled, randomized trial of in 16,608 women age 50-79 yr
Drug dose: CEE 0.625 mg/day plus MPA 2.5 mg/day
Postintervention phase included 15,730 women
Primary end points: coronary heart disease and invasive breast cancer
Global index summarizing the balance of risks and benefits included primary end points plus stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death due to other causes
Results
Post-intervention risk of cardiovascular events was comparable by initial randomized assignments
Greater risk of malignancies occurred in the CEE plus MPA than in the placebo group
More breast cancers were diagnosed in women randomized to CEE plus MPA vs placebo, with a modest trend toward a lower HR during post-intervention follow-up
All-cause mortality was higher in the CEE plus MPA than in the placebo group
Global index of risks/benefits was unchanged from randomization, indicating that risks of CEE plus MPA exceed benefits for chronic disease prevention
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