Evista, raloxifene is classified as an estrogen agonist/antagonist. This means it acts like estrogen in some tissues like the bone and liver and blocks the estrogen receptor in others like the breast. Leo Plouffe M.D. and his team of brilliant medical scientists at Eli Lilly and Company painstakingly developed Evista for osteoporosis prevention and treatment and then for breast cancer prevention. The most common side effect is hot flushes but most women tolerate raloxifene well.
Raloxifene Indications from the Evista Product Label
EVISTA® is an estrogen agonist/antagonist indicated for:
- Treatment and prevention of osteoporosis in postmenopausal women.
- Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
- Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.
In 2 studies of raloxifene included 1145 women that were on average 54 years old in whom it had been 5 years since their last menstrual period. These European and North American women were mostly white; all took 1 calcium tablet daily and had osteopenia on bone density testing with a T-score between –2.0 and –2.5. After completion of the 2 years trial, those in the raloxifene group increased their bone density by about 2% in the hip and spine while those in the placebo groups lost 1%.
Raloxifene was studies in a 3 years study of 7705 postmenopausal women with osteoporosis (MORE). Their average age was 67. All study subjects took calcium and vitamin D.
The fracture rate in the placebo group was 43 per 1,000 vs. 12 per 1,000 in the Evista group for a 55% relative risk reduction. The absolute risk reduction was 2.4%, meaning that 40 women like those in the study would need to be treated with Evista for 3 years to prevent 1 new spine fracture.
There was no difference in peripheral fractures seen between the two groups.
The bone density in the spine increased on raloxifene in the spine and hip on average 2% to 3%, which was statistically significant
Breast Cancer Prevention
Raloxifene is in the same class as tamoxifen (Novaldex) that has been indicated for prevention and treatment of breast cancer for many years. There was a 68% relative risk reduction in breast cancer in the Evista treated women in the MORE osteoporosis trial vs. the placebo women. The RUTH trial study was conducted in 10,101 postmenopausal women at higher than average risk for breast cancer. At the start of the 5.6-year study, their average age was 67 years and 84% were white. The breast cancer rate was about 3 per 1,000 in the placebo group vs. 2 per 1,000 in those on Evista, which translates into a relative risk reduction of breast cancer by 44% with an absolute risk reduction of 1.2%.
Raloxifene Side effects
The only statistically significant side effect of raloxifene in studies of over 15,000 postmenopausal women is hot flushes. The incidence of hot flushes was 9% in the MORE osteoporosis study and 5% in the RUTH breast cancer study of raloxifene. This side effect can be managed in several clever ways using an herbal product, Relizen, use of one of the SSRIs like paroxetine that are now US FDA indicated for hot flush reduction, or adding a small dose of topical estrogen to the raloxifene. Most women say the hot flushes wane with time even without any treatment.
The label includes dire warnings about Deep Vein Thrombosis, Pulmonary Embolism, Stroke, and Death from Stroke. The truth is these things did not happen significantly in any of the research studies. The data does not support the US FDA requiring Lilly to classify these events that occurred in statistically equal numbers of people on raloxifene and placebo side effects of raloxifene. There was a slight increase risk seen for dying if you have a stroke on raloxifene compared to having a stroke on placebo. Clearly, the data shows raloxifene does not cause stroke, deep vein thrombosis, or pulmonary embolism and never has. Having these in the product label misleads consumers and clinicians and should be removed.
These studies show conclusively that raloxifene does not cause ovarian cancer or uterine cancer.