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Senior Citizen Health & Medicine

Raloxifene Again Found to Deter Breast Cancer in Older Women, plus Vertebral Fractures

But study finds increased problems of blood clots and fatal strokes

July 17, 2006 – As several earlier major studies have determined, the latest research on the raloxifene confirms its ability to deter breast cancer. The new report in the July 13 issue of the New England Journal of Medicine focuses on postmenopausal women with a history or high risk of heart disease. The study of 10,000 women for more than five years found raloxifene not only reduced the incidence of breast cancer but also vertebral fractures. The surprising bad news is it produced increased problems of blood clots and fatal strokes.

 

Related Stories

 
 

Weight Gain May Increase Risk of Breast Cancer in Older Women

Problem increases if weight gain is after menopause

July 11, 2006 - Weight gain, particularly after menopause, is associated with an increased risk of breast cancer in women, according to an article in the July 12 issue of JAMA. Read more...

Tamoxifen and Raloxifene Both Guard Against Invasive Breast Cancer, But…

Raloxifene the rising star says editorial in JAMA

June 5, 2006 - Raloxifene and tamoxifen are both effective in reducing the risk of invasive breast cancer, but each has potential disease and quality of life side effects that women and their physicians will need to consider, according to two reports and an editorial published online June 5 by JAMA. Read more...

Older Women with Early Breast Cancer have Better Survival with Aromasin

Company says 17% less deaths when switched from tamoxifen

June 3, 2006 - New data from the Intergroup Exemestane Study (IES) showed for the first time today that hormone sensitive postmenopausal early breast cancer patients who switched to Aromasin after 2 to 3 years of tamoxifen were 17% more likely to be alive and were 25% less likely to have their cancer return than patients who continued on tamoxifen for a full 5 years of therapy. The news was issued by the company. Read more...

Success of Raloxifene to Prevent Breast Cancer is Encouraging for Senior Women

Osteoporosis drug Raloxifene as effective as Tamoxifen without side effects

April 19, 2006 – The study released Monday showing the drug raloxifene, currently used to prevent and treat osteoporosis in postmenopausal women, works as well as tamoxifen in reducing breast cancer risk, without some of the side effects, is encouraging news for female senior citizens, who are at the highest risk of breast cancer. The disease is expected to strike 213,000 American women this year, with the majority being over 50 years of age. The results show less uterine cancer and blood clots from raloxifene. Read more...


Read more on Health & Medicine

 

The study definitely 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 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 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 raloxifene 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.

Tamoxifen is a SERM that has been used to treat both early and advanced breast cancer for more than three decades

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.

Results of Earlier Studies

Reports published June 5 online by the Journal of the American Medical Association said raloxifene and tamoxifen were both effective in reducing the risk of invasive breast cancer, but each has potential disease and quality of life side effects that women and their physicians will need to consider.

There were fewer cases of noninvasive breast cancer in the tamoxifen group (57 cases) than in the raloxifene group (80 cases), while there were 36 cases of uterine cancer with tamoxifen and 23 with raloxifene; however, neither of these differences were statistically significant.

No differences were found for other invasive cancer sites, for ischemic heart disease events, or for stroke.

Thromboembolic events (such as blood clots in the lung or deep veins) occurred less often in the raloxifene group and there were fewer cataracts and cataracts surgeries in that group.

The number of osteoporotic fractures in the two groups was similar. There were no differences in the total number of deaths or in causes of death.

An early study in April also found raloxifene works as well as tamoxifen in reducing breast cancer risk, without some of the side effects. This study also found less uterine cancer and blood clots from raloxifene.

"Today, we can tell you that for postmenopausal women at increased risk of breast cancer, raloxifene is just as effective, without some of the serious side effects known to occur with tamoxifen," said Norman Wolmark, M.D., Chairman of the National Surgical Adjuvant Breast and Bowel Project, a network of cancer research professionals that sponsored this trial. It is sponsored by the National Cancer Institute, part of the National Institutes of Health.

Women taking either drug, in this study, had equivalent numbers of strokes, heart attacks, and bone fractures.

The mixed results of the studies 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 authors of today's report.

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