Investigators at Wake Forest Baptist Medical Center have concluded research on a new postmenopausal hormone therapy that shows promise as an effective treatment for menopausal symptoms and the prevention of osteoporosis without increasing the risk for heart disease or breast cancer.
Traditional forms of hormone therapy (HT) provide the benefits of symptom relief, prevention of osteoporosis and prevention of atherosclerosis, but increase the risk of uterine cancer (with estrogens alone) or breast cancer (with combined estrogens and progestins). Thus, the risk-benefit ratio of traditional HT is not ideal. Less potent plant-derived estrogens are relatively safe, but less effective. Selective estrogen receptor modulators (SERMs) provide both beneficial effects and adverse effects, but the ideal treatment has proven elusive, said J. Mark Cline, D.V.M., Ph.D., one of the co-authors.
The Wake Forest Baptist team worked in partnership with the pharmaceutical company Pfizer to explore a new strategy, termed a Tissue Selective Estrogen Combination (TSEC). Using this strategy, a conventional estrogen (CEE) was combined with a bone-protective SERM-like drug, bazedoxifene acetate (BZA), to produce a complementary pattern of tissue effects that maximize the benefits of HT while avoiding the risk. The study involved a 20-month randomized, parallel-arm trial – which has a comparison group and at least one new or active therapy group – in postmenopausal nonhuman primates, designed to determine the effect of TSEC treatment on the breast, uterus and cardiovascular system.
The TSEC strategy has been evaluated in the Selective estrogens, Menopause, And Response to Therapy (SMART) phase 3 trials involving more than 6,000 women. Cline said the Wake Forest Baptist nonhuman primate trials are important because they can address tissue responses directly, whereas studies in women use clinical outcomes that may require many years to provide conclusive results.
The Wake Forest Baptist findings are discussed in separate papers, both published recently in Menopause: The Journal of The North American Menopause Society.
Prior work by Cline in the 1990s demonstrated the adverse effect of a widely used estrogens and estrogen-progestin combination on the breast, a finding that was predictive of the breast cancer patterns later found in the Women's Health Initiative. In contrast to that finding, the TSEC strategy is anticipated to reduce breast cancer risk. "Remarkably, BZA overrides the adverse effects of CEE at the level of gene expression in the breast, suppressing abnormal tissue growth," Cline said.
Lead investigator Thomas B. Clarkson, D.V.M., is hopeful about the promise of this new approach. "The findings are encouraging for postmenopausal women," he said. "We believe that women can be given CEE along with BZA to protect against breast cancer and uterine cancer, without adversely affecting the cardiovascular system, but more research is necessary."
Other team members include: Kelly F. Ethun, D.V.M., Charles E. Wood, D.VM., Ph.D, Thomas C. Register, Ph.D, and Susan E. Appt, D.V.M., all of Wake Forest Baptist.
Wake Forest School of Medicine received an investigator-initiated grant to Clarkson from Pfizer to conduct the work described. Clarkson and Cline have been paid consultants for Pfizer. Appt is the principal investigator on a pending investigator-initiated proposal to Pfizer, related to further development of the TSEC approach.
Bonnie Davis | EurekAlert!
Scientists develop tiny tooth-mounted sensors that can track what you eat
22.03.2018 | Tufts University
NIH scientists describe potential antibody treatment for multidrug-resistant K. pneumoniae
14.03.2018 | NIH/National Institute of Allergy and Infectious Diseases
An international team of researchers has discovered a new anti-cancer protein. The protein, called LHPP, prevents the uncontrolled proliferation of cancer cells in the liver. The researchers led by Prof. Michael N. Hall from the Biozentrum, University of Basel, report in “Nature” that LHPP can also serve as a biomarker for the diagnosis and prognosis of liver cancer.
The incidence of liver cancer, also known as hepatocellular carcinoma, is steadily increasing. In the last twenty years, the number of cases has almost doubled...
In just a few weeks from now, the Chinese space station Tiangong-1 will re-enter the Earth's atmosphere where it will to a large extent burn up. It is possible that some debris will reach the Earth's surface. Tiangong-1 is orbiting the Earth uncontrolled at a speed of approx. 29,000 km/h.Currently the prognosis relating to the time of impact currently lies within a window of several days. The scientists at Fraunhofer FHR have already been monitoring Tiangong-1 for a number of weeks with their TIRA system, one of the most powerful space observation radars in the world, with a view to supporting the German Space Situational Awareness Center and the ESA with their re-entry forecasts.
Following the loss of radio contact with Tiangong-1 in 2016 and due to the low orbital height, it is now inevitable that the Chinese space station will...
Fraunhofer Institute for Organic Electronics, Electron Beam and Plasma Technology FEP, provider of research and development services for OLED lighting solutions, announces the founding of the “OLED Licht Forum” and presents latest OLED design and lighting solutions during light+building, from March 18th – 23rd, 2018 in Frankfurt a.M./Germany, at booth no. F91 in Hall 4.0.
They are united in their passion for OLED (organic light emitting diodes) lighting with all of its unique facets and application possibilities. Thus experts in...
A new scenario seeking to explain how Mars' putative oceans came and went over the last 4 billion years implies that the oceans formed several hundred million...
For the first time, an interdisciplinary team from the University of Basel has succeeded in integrating artificial organelles into the cells of live zebrafish embryos. This innovative approach using artificial organelles as cellular implants offers new potential in treating a range of diseases, as the authors report in an article published in Nature Communications.
In the cells of higher organisms, organelles such as the nucleus or mitochondria perform a range of complex functions necessary for life. In the networks of...
19.03.2018 | Event News
16.03.2018 | Event News
13.03.2018 | Event News
22.03.2018 | Trade Fair News
22.03.2018 | Earth Sciences
22.03.2018 | Earth Sciences