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Increased Risks Lead To Halt In Large US Estrogen/Progestin Trial

Researchers with the Women's Health Initiative trial have halted the estrogen plus progestin portion of the study because of apparent increases in risks for invasive breast cancer, coronary heart disease (CHD), stroke and pulmonary embolisms among participants.

They list the absolute excess risks attributable to estrogen plus progestin per 10,000 person-years as: eight more invasive breast cancers, seven more CHD events, eight more strokes and eight more pulmonary embolisms.

They also found absolute risk reductions per 10,000 person-years of six fewer colorectal cancers and five fewer hip fractures.

"The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD," the researchers comment.

Investigators tabulated the absolute excess risk of events included in their global index as 19 per 10,000 person years.

The researchers, led by Dr. Jacques Rossouw of the US National Heart, Lung and Blood Institute in Bethesda, Maryland, halted the trial May 31 this year after a mean of 5.2 years of follow-up. The trial was scheduled to follow the women for 8.2 years.

It was reported that overall heath risks exceeded benefits from the use of conjugated equine estrogens (0.625 milligrams per day) plus medroxyprogesterone acetate (2.5 mg/d), combined in one tablet.

A total of 16,608 healthy postmenopausal women with an intact uterus, recruited from 40 United States clinics, had been participating in the trial. They were enrolled between 1993 and 1998.

Hazard ratios (HRs) for composite outcomes were found to be: 1.22 for total cardiovascular disease (arterial and venous disease), 1.03 for total cancer, 0.76 for combined fractures, 0.98 for total mortality and 1.15 for the global index.

The researchers say the results address the important issue of whether most women with an intact uterus in the decades after menopause should consider hormone therapy to prevent chronic disease.

They note that the Women's Health Initiative enrolled a cohort of mostly healthy, ethnically diverse women whose ages spanned almost three decades, from 50 to 79 years at baseline.

They point out that the increased risks for cardiovascular disease and invasive breast cancer were found across racial/ethnic and age strata.

"Hence the results are likely to be generally applicable to healthy women in this age range."
JAMA, 2002; 288: 321-333.

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