Skip Ribbon Commands
Skip to main content
Translate
Donations
menu iconMenu
search iconSearch

Major Study Shows Risks/Benefits of Osteoporosis Drug Use in Postmenopausal Women

 

July 17, 2006  |  

The drug may help prevent breast cancer and vertebral fractures, but raise the risk of blood clots and fatal strokes

A study in the July 13 issue of the New England Journal of Medicine, reporting the results of a 5-1/2 year-long trial of more than 10,000 postmenopausal women with a history of heart disease or at high risk for heart disease, shows that patients given raloxifene therapy had a reduced incidence of vertebral fractures and breast cancer, but an increased incidence of blood clots and fatal strokes. The multi-site international study was headed by Elizabeth Barrett-Connor, M.D., Professor of Family and Preventive Medicine at the University of California, San Diego (UCSD) School of Medicine.

The study showed mixed results. On the positive side, raloxifene therapy reduced invasive breast cancer by 44 percent with 1.2 fewer cases per 1000 women treated for one year. Raloxifene has anti-estrogenic effects in the breast, inhibiting the growth of estrogen-stimulated breast cancer. It also reduced painful vertebral fractures by 35% with 1.3 fewer cases per 1000 women.

On the other hand, use of raloxifene was shown to raise the risk of blood clots by 44%, or 1.2 cases per 1000 women treated for one year. Additionally, 59 of the 5,044 raloxifene users had fatal strokes, compared to only 39 of the half on placebo, an absolute increase of 0.7 cases per 1000 women treated for one year, or a 49 percent greater risk of stroke-related death – though there was no significant difference in the total number of stroke episodes.

"The breast cancer prevention benefits may not justify the risks of taking raloxifene for some patients, especially those already prone to heart problems, because of the risk related to other diseases," said Barrett-Connor, who added that women should talk about risks with their doctors.

Doctors had thought that the drug might help prevent heart problems, because it lowers cholesterol levels. However, the study showed that raloxifene therapy did not significantly reduce the risk of coronary events such as heart attack, hospitalization or death in the clinical trial group assigned to raloxifene therapy, made up of women with previous established or proven risk of heart disease.

Raloxifene is a non-steroidal selective estrogen-receptor modulator (SERM) produced by Eli Lilly. The drug is sold as Evista for preventing and treating osteoporosis, and has also been tested by doctors as an alternative to tamoxifen for preventing breast cancer in a previous trial.

The Raloxifene Use for the Heart (RUTH) trial began in 1998 to determine the effects of the drug on clinical coronary events in women with or at increased risk for coronary heart disease. Eligible participants were women age 55 years or older, who were at least one year postmenopausal, and had established or risk factors for heart disease such as clogged arteries, high blood pressure or cholesterol level, smoking or diabetes. Women at 177 sites in 26 countries were randomly assigned to treatment or placebo.

After an average of five years, the RUTH study showed that deaths and major heart problems were about the same in both the group receiving raloxifene and those taking a placebo. Raloxifene users experienced one-third fewer cases of breast cancer and about half the number of invasive breast cancers.

The mixed results of the study make it vital that women talk with their doctors about treatment options, and weigh the risk/benefit ratio in light of their own health history, according to the study’s authors.

# # #

Media Contact:  

Debra Kain, 619-543-6163, ddkain@ucsd.edu

UCSD Health Sciences Communications HealthBeat: News

 

 




Media Contact

Related News

5/26/2015
The Huntington's Disease Clinical Research Center (HDCRC) at UC San Diego Health System has been designated a Center of Excellence by the Huntington’s Disease Society of America (HDSA). UC San Diego w ...
5/25/2015
Researchers at University of California, San Diego School of Medicine and Moores Cancer Center have now identified six mRNA isoforms (bits of genetic material) produced by ovarian cancer cells but not ...
5/21/2015
Using human embryonic stem cells, researchers at University of California, San Diego School of Medicine and Moores Cancer Center and Sanford-Burnham Medical Research Institute created a model that all ...
5/18/2015
A binational team from the University of California, San Diego School of Medicine and the U.S.-Mexico Border Health Commission, Mexico Section has launched a new research project aimed at promoting pr ...
5/17/2015
For parents who send their kids to dance classes to get some exercise, a new study from researchers at University of California, San Diego School of Medicine suggests most youth dance classes provide ...
5/8/2015
Therapies that specifically target mutations in a person’s cancer have been much-heralded in recent years, yet cancer cells often find a way around them. To address this, researchers at University of ...
5/7/2015
Researchers at University of California, San Diego School of Medicine and Shiley Eye Institute have identified the molecular “glue” that builds the brain connections that keep visual images clear and ...
5/7/2015
Writing in the May 7 online issue of American Journal of Geriatric Psychiatry, researchers at University of California, San Diego School of Medicine and Veterans Affairs San Diego Healthcare System su ...


Share This Article



Follow Us