Evista (raloxifene hydrochloride)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Evista (raloxifene hydrochloride, 60 mg) has been approved for
the prevention of osteoporosis in postmenopausal women. Evista, the
first in a class of new drugs called selective estrogen receptor
modulators (SERMs) to be approved by the FDA for marketing for the
prevention of osteoporosis, is being studied for its selective
ability to act like estrogen in some tissues but not in others.
The FDA reviewed data from 50 studies conducted in 28 countries
to establish the safety and efficacy of Evista for the prevention
of postmenopausal osteoporosis. More than 12,000 women have
participated in the clinical program to date.
A total of 1,764 postmenopausal women participated in pivotal
phase III osteoporosis prevention studies. In two studies, women
were randomly assigned to take Evista or placebo. In the third
study, women took Evista, placebo, or estrogen replacement therapy.
All the women took calcium supplements. In each study, Evista was
superior when compared with placebo in preventing bone loss in the
lumbar spine and hip. These pivotal clinical trials also showed
that Evista builds bone, although to a lesser extent than
As with most drugs, Evista was associated with some side
effects, the majority of which were reported as mild. A rare but
serious side effect associated with Evista was an increase in
venous thromboembolic events. The most-commonly observed side
effect was hot flashes. Women taking Evista also reported a higher
rate of leg cramps than women taking placebo. The leg cramps,
generally reported as mild, did not cause women to discontinue