Health Outcomes During and After Hormone Therapy: A Comprehensive Look at Women's Health Initiative Data

Andrew M. Kaunitz, MD

Long-term analyses clarify the differing effects of menopausal HT formulation and user age at initiation.

Earlier findings from the Women's Health Initiative hormone therapy trials, which enrolled women aged 50 to 79, are well known. Now, investigators have published an outcomes analysis of both trials based on extended cumulative follow-up (median, 13 years) with stratification by age.

Among women randomized to oral conjugated equine estrogens (CEE) + medroxyprogesterone acetate (MPA) compared with placebo, small but statistically significant elevations in risk for invasive breast cancer (hazard ratio, 1.24), stroke (HR, 1.37), and pulmonary embolism (HR, 1.98), as well as reductions in risk for colorectal cancer (HR, 0.62), hip fracture (HR, 0.67), and diabetes (HR, 0.81) occurred during the intervention phase. The changes in risk for all of these outcomes except breast cancer diminished during the post-intervention phase. Among women randomized to CEE compared with placebo, small but statistically significant elevations in risk for stroke (HR, 1.35) as well as statistically significant reductions in hip fracture (HR, 0.67) and diabetes (HR, 0.86) were observed during the intervention phase, with the changes in risk for these outcomes again diminishing during the post-intervention phase. Cumulatively, randomization to CEE was associated with reduced risk for invasive breast cancer (HR, 0.79). Neither CEE + MPA nor CEE alone significantly affected all-cause mortality during or after the intervention phase. Among the subset of women aged 50 to 59, the CEE-alone group had fewer myocardial infarctions and significantly lower all-cause mortality.

Citation(s):

Manson JE et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA 2013 Oct 2; 310:1353.