New advances in thrombosis help further understanding of disease ...( s in this area and new treatment option...)

Hormone Therapy and Venous Thrombosis: Final Results of the Women's Health Initiative Trial of Estrogen Plus Progestin (Abstract 729)

The Women's Health Initiative (WHI) is a large-scale, 15-year research program that includes multiple clinical trials designed to assess the most common causes of death, disability, and poor quality of life in postmenopausal women cardiovascular disease, cancer, and osteoporosis. One of the WHI studies was a clinical trial that included 16,608 women aged 50 to 79 who were randomized to receive either conjugated equine estrogen (0.625 mg per day) and medroxyprogesterone acetate (2.5 mg per day) or placebo. The trial ended early (5.2 years) after finding that the associated health risks of estrogen plus progestin (E+P) outweighed the potential benefits of the treatment. Researchers continue to analyze and report on data from this trial while they complete other WHI studies.

The final results related to deep vein thrombosis and pulmonary embolism from this trial showed that women experienced a two-fold increased risk of developing this potentially fatal condition while using E+P. Thrombosis risk factors were similar for the E+P and placebo-assigned women one third of the women were 50 to 59 years old; 22 percent were 70 to 79 years old; 84 percent were white; 35 percent were overweight [body mass index (BMI) 25 to 29]; and one third were obese (BMI = 30). Thrombosis occurred in 167 women in the E+P arm compared to 76 with placebo, a 2.1 fold increased risk [95 percent confidence interval (CI) 1.6 to 2.7]; the risk increase was similar for deep vein thrombosis and pulmonary embolism. The primary determinants of risk of thrombosis were increasing age and obesity. The risk of thrombosis with E+P was higher earlier in the study, with a four-fold increased risk in the first year.

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Contact: Aimee Frank
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American Society of Hematology
6-Dec-2003