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Evista: Help for Breast Cancer, Heart?
July 12, 2006 -- Hopes that the osteoporosis drug Evista would offer women a clearly safer alternative to tamoxifen for breast cancer prevention have been dashed by findings from a long-awaited study, researchers say.
The postmenopausal women in the trial all had risk factors for coronary heart disease and were considered at risk for heart attack and stroke.
Women who took Evista did develop significantly fewer breast cancers than women randomly assigned to take a placebo (medicine-free treatment) in the approximately five-year study. But they also had significantly more fatal strokes and potentially dangerous blood clots.
Researchers concluded that the benefits of Evista for preventing osteoporosis and breast cancer have to be weighed against the risk of stroke and blood clots on a case-by-case basis.
The study appears in tomorrow's issue of the New England Journal of Medicine. It was funded, in part, by Evista manufacturer Eli Lilly. Eli Lilly is a WebMD sponsor.
"This study highlights the fact that we cannot look at one condition or one outcome when we consider a drug for prevention," says Lori Mosca, MD, PhD, researcher on the " Raloxifene Use for the Heart" (RUTH) study.
Mosca tells WebMD that she considers the findings "somewhat disappointing."
"This trial was pretty much a wash in terms of benefits vs. risks in this population [at high risk for cardiovascular events]," she says. "The bar has to be higher for drugs used for prevention of diseases than for drugs used to treat them. I think there needs to be a clear indication of benefit."
No Heart Benefits
As the name suggests, the original goal of the RUTH trial was to determine if Evista could help prevent heart attacks and strokes in women at high risk for heart disease.
Evista is in a class of drugs known as selective estrogen receptor modulators (SERMs). Tamoxifen, which is also a SERM, is approved for breast cancer prevention in high-risk women and for the treatment of breast cancer.
A total of 10,101 postmenopausal women with multiple risk factors for heart disease participated in the RUTH trial; roughly half took Evista every day for an average of five years and the other half unknowingly took an identical-looking placebo.
The number of cardiac events experienced by the two groups was similar. But significantly fewer breast cancers were diagnosed in the Evista users than in those on placebo (40 vs. 70).
Deaths from any cause were also similar in both groups, and the two groups had roughly the same number of strokes. But Evista users had significantly more fatal strokes (59 vs. 39) and potentially dangerous blood clots (103 vs. 71 events) than women taking placebo.
Mosca points out that women taking the SERM also had a higher incidence of several nonlife- threatening, but troubling, side effects, including hot flashes and leg cramps.
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