Evista, a controversial choice for warfarin patients
By: Alere Staff
A study of more than 10,000 postmenopausel women evaluating the risk of invasive breast cancer found a 44% decrease in cancer at the cost of a 49% increased risk of thromboembolic events including fatal strokes. The report calls attention to the risks of increased stroke risk for women.
The RUTH (Raloxifene Use for The Heart) trial investigators randomly assigned 10,101 postmenopausal women (mean age 67.5) with established coronary heart disease or multiple risk factors for heart disease to either 60 mg of Evista daily or placebo. The women were followed for a median of 5.6 years. The primary endpoints were coronary events and invasive breast cancer.1
In this group of women at high risk for coronary events,"the difference in absolute rates of events that were decreased (i.e., breast cancer and clinical vertebral fractures) was similar to the difference in the absolute rates of events that were increased (i.e., venous thromboembolic events and fatal strokes)," the authors wrote.2
The future of Evista may be in question."When a drug increases cardiovascular risk, we have to take that seriously," he said adding that Dr. Barrett-Connor and colleagues did an excellent job of "laying out the risks and benefits very clearly, with no spin."
According to Evista.com, "EVISTA is not for everyone. If you are or still can become pregnant, are nursing, have severe liver problems, or have had blood clots that required a doctor's treatment, you cannot take EVISTA. An infrequent but serious side effect of EVISTA is blood clots in the veins, being immobile for a long time may add to the risk. In a study of postmenopausal women at high risk for cardiovascular disease taking EVISTA, there was no increase in the incidence of stroke; however, there was an increase in the incidence of death due to stroke."
Much controversy remains around this heavily marketed product. More frequent testing for high risk patients decreases the chance of sub/supra therapeutic INR test results.
- Barrett-Connor E et al. Effects of Raloxifene on Cardiovascular Events and Breast Cancer in Postmenopausal Women. N Engl J Med 2006;355:125-37 .
- Peck P. Evista Prevents Breast Cancer but Increases Risk of Fatal Strokes. http://www.medpagetoday.com/HematologyOncology/BreastCancer/dh/3716. July 2006.