Healthcare Industry News: osteoporosis
News Release - June 3, 2006
New Data Show That Five Years of Treatment With Arimidex(R) (anastrozole) Did Not Cause Osteoporosis in Early Breast Cancer Patients With Normal Bone Mineral Density at OutsetResults from full course of treatment answer an important clinical question about the impact of ARIMIDEX therapy on a woman's bone mineral density
ATLANTA, June 3 (HSMN NewsFeed) -- New data reported today from a five-year update from the bone sub protocol of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial (Abstract # 511) confirm that women who have a normal bone mineral density (BMD) at the outset of treatment may be able to undergo a five-year course of therapy with ARIMIDEX (anastrozole) without the risk of developing osteoporosis. These trial results, a subset of data from one of the world's longest running and largest studies of breast cancer treatment after surgery, were presented today at the American Society for Clinical Oncology (ASCO) Annual Meeting. ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.
The results of this study indicate that a reduction in BMD does occur over the five-year course of treatment with ARIMIDEX, although there appeared to be a slowing down of the rate of bone loss in the lumbar spine in years two to five. These study results provide additional evidence that bone adverse events are predictable and may be manageable, with proper monitoring, for ARIMIDEX.
The impact of aromatase inhibitors, such as ARIMIDEX, on BMD has been an important clinical question for physicians and breast cancer patients alike. In addition, recent treatment guidelines also highlighted that additional evidence was needed regarding the effect of aromatase inhibitors on bone strength. These results provide further support for current guidelines the use of aromatase inhibitors, such as ARIMIDEX, for the treatment of early breast cancer in postmenopausal women, specifically in patients with normal baseline BMD.
"When deciding what's best for our patients, we look to clinical evidence and guidelines to lead our choices," said Aman Buzdar, M.D., professor of medicine for the department of breast medical oncology at The University of Texas M. D. Anderson Cancer Center in Houston, and Chair of the steering committee for the ATAC Trial. "Guidelines are now strongly recommending the use of an aromatase inhibitor in postmenopausal, hormone receptor-positive early breast cancer patients, and ARIMIDEX offers the longest experience and strong evidence of safety and efficacy."
Mature data drive clinical decisions
The majority of the women in the ATAC trial have now completed their five years of treatment, so the data from this bone sub protocol reflect the benefits and risks of a complete course of treatment with ARIMIDEX. Data this mature does not exist for any other aromatase inhibitor.
Extensive clinical trial data, including those from the ATAC trial, and recent treatment guidelines continue to support the use of ARIMIDEX to reduce the risk of recurrence of breast cancer following surgery. Clinicians are making their prescribing decisions on the basis of such evidence, and changing the treatment paradigm based on their confidence in the evidence.
About ARIMIDEX® (anastrozole)
ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
Important Safety Information About ARIMIDEX
ARIMIDEX should only be used in postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment, pregnancy must be excluded (see WARNINGS in full Prescribing Information). Common side effects seen with ARIMIDEX in the early breast cancer clinical trial include hot flashes, joint symptoms, weakness, mood changes, pain, sore throat, nausea and vomiting, depression, high blood pressure, osteoporosis, swelling of arms-legs, and headaches. Fractures, including spine, hip, and wrist fractures, occurred more often with ARIMIDEX than tamoxifen.
ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.
NOLVADEX® (tamoxifen citrate) is approved for the adjuvant treatment of node-positive and node-negative early breast cancer in postmenopausal women following breast surgery and radiation. In some NOLVADEX adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.
Important Safety Information About Tamoxifen
WARNING: Serious and life-threatening events associated with NOLVADEX include cancer of the uterus, stroke, and blood clots, some of which have been fatal. In clinical trials, uterine cancers, including endometrial cancer and uterine sarcomas, and blood clots, including clots in the lungs, occurred 2 to 4 times more often with NOLVADEX than placebo, but each occurred in less than 1% of women. For most women with breast cancer, the benefits of NOLVADEX outweigh its risks. If you are taking NOLVADEX to reduce your risk of developing breast cancer because you are at high risk or have DCIS, you should discuss these warnings with your health care provider.
Women who are pregnant or who plan to become pregnant should not take NOLVADEX. Women who have a history of blood clots or who currently use anticoagulants (blood thinners) should not take NOLVADEX for DCIS or to reduce their risk of breast cancer. Cataracts and cataract surgery occurred more frequently with NOLVADEX. The most frequently reported adverse reactions were hot flashes and vaginal discharge.
Please see full Prescribing Information including boxed WARNING regarding NOLVADEX Tablets.
AstraZeneca (NYSE: AZN ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com
ARIMIDEX and NOLVADEX are registered trademarks of the AstraZeneca group of companies.
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