Oestrogen-only hormone replacement therapy (HRT) may increase the risk of developing asthma after the menopause, suggests a large scale study published ahead of print in the journal Thorax. The authors base their findings on 57, 664 women, who were quizzed about their use of HRT and development of asthma symptoms every two years between 1990 and 2002. All the women were taking part in the French E3N study, which includes almost 100, 000 women born between 1925 and 1950, and is the French component of the European Prospective Investigation into Cancer and Nutrition (EPIC). None of these women had asthma when menopausal symptoms began. The monitoring period equated to 495, 448 person years in all, of which over a third was accounted for by women who had not used HRT (35.7%). Previous users made up 4.5% while information on how long HRT was used was not known for a further 4%. Of the remainder, just under 56% were recent users of HRT. Between 1990 and 2002, 569 women were newly diagnosed with asthma, corresponding to a rate of 1.
Women experiencing an early onset of menopause could develop dementia at a younger age. Research by Tonnie Coppus of Erasmus MC has indicated this. She studied women with Down Syndrome, who are known to have an early onset of menopause. The results of her research can be translated to apply to the general population. Her results are published in the Journal of Alzheimer Disease. Women with Down Syndrome have an earlier onset of menopause compared to women in the general population, 44 years of age and 52 years of age, respectively. Coppus' findings show a strong relationship between the age of menopause onset and the age at which dementia is diagnosed. Coppus: "Women with Down Syndrome with an early onset of menopause also appear to suffer from dementia at an early age. In addition, my study shows that these women also die younger." Alzheimer's disease is the major cause of illness and death among people with Down Syndrome. The Epidemiology department of Erasmus MC has been studying more than 500 people with Down Syndrome, above the age of 45, since 2000.
Depomed, Inc. (NASDAQ:DEPO) announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a U.S. patent application (No. 12/239, 591) directed to pharmaceutical dosage forms that deliver the compound gabapentin via Depomed's proprietary Acuform® gastric retentive drug delivery technology. Paul B. Simboli, Depomed's senior director of Intellectual Property, noted that with the issuance of this additional patent, Depomed will hold six U.S. patents covering DM-1796, its product candidate for postherpetic neuralgia licensed to Solvay Pharmaceuticals, and holds or has sublicensed seven U.S. patents covering SeradaTM, its product candidate for menopausal hot flashes. The patents have expiration dates ranging from 2016 to 2024. The 21 newly allowed claims will expire in 2024. Carl A. Pelzel, Depomed's president and chief executive officer, added, "This new patent further expands the patent portfolio around our extended release gabapentin formulation technology.
Depomed Comments On FDA Guidance And Plans For One Additional Phase 3 Clinical Trial Evaluating Non-Hormonal Therapy For Menopausal Hot Flashes
Depomed, Inc. (NASDAQ:DEPO) announced it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company's extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes. The company expects to initiate the trial, which will be known as Breeze 3, by the end of April 2010 and to complete the trial by the end of the first quarter of 2011. The FDA has agreed to review the proposed Breeze 3 study protocol under the FDA's Special Protocol Assessment (SPA) process. "We believe Serada continues to hold the potential to be the first non-hormonal treatment to address menopausal hot flashes, a significant unmet need in women's health, " said Michael Sweeney, M.D., Depomed's vice president, Research and Development. Carl A.
The 8th U.S. Circuit Court of Appeals in St. Louis on Wednesday reinstated more than 100 lawsuits against pharmaceutical companies filed by women or their surviving relatives claiming that the companies' hormone replacement therapy drugs caused breast cancer, the AP/San Francisco Chronicle reports. The AP/Chronicle reports that the women -- whose ages ranged from their 30s to their 80s -- received the HRT drugs, such as the combination estrogen-progestin drug Prempro, to treat symptoms of menopause. There are several thousand similar lawsuits filed nationwide. The appellate court's decision overturns a 2008 district court's dismissal of the cases that prevented them from being heard in state courts in Arkansas and Minnesota. The new decision also reinstates dozens of cases that the lower court dismissed because they reportedly duplicated claims that are pending in California. According to the AP/Chronicle, the plaintiffs argued that the district court judge failed to provide them with a "reasonable opportunity" to be heard.
Aneeve Nanotechnologies LLC has been selected to work in the UCLA on-campus Technology Incubator Program at the California NanoSystems Institute. The startup company will conduct early-stage research for the development of a novel hormone sensor/meter for biomedical applications in the areas of infertility and menopause. Aneeve has licensed related carbon nanotube technology from UCLA developed by Kang Wang, a UCLA professor of electrical engineering. The technology increases hormonal detection sensitivity significantly, allowing detection beyond traditional sensors. The company is using this technology to develop biomedical applications that are low in power consumption and small in size and that involve ultra-sensitive nanoelectronic technologies. Aneeve's primary research focus within the incubator will be to develop a consumer-based, simple-to-use meter for sensing estrogen and progesterone hormone levels to assist women in mitigating unwanted symptoms of menopause. The meter will provide on-demand hormonal levels so patients can better control drug intake related to hormone therapy.
According to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM), postmenopausal HIV-infected women have a high prevalence of low bone mineral density and high bone turnover placing them at high risk for future bone fractures. "As HIV-infected individuals live longer with potent antiretroviral therapy (ART), metabolic complications such as low bone density and osteoporosis are increasingly recognized, " said Michael Yin, MD of Columbia University Medical Center in New York and lead author of the study. "Although numbers of HIV-infected postmenopausal women are increasing and postmenopausal women are at highest risk for osteoporotic fractures, few studies have evaluated skeletal status in this group. We hypothesized that postmenopausal women might be particularly vulnerable to the adverse effects of HIV infection or ART on the skeleton and our results indicate that this may indeed be the case." To test their hypothesis, Yin and his colleagues initiated a longitudinal study to assess bone health in 92 HIV-positive and 95 HIV-negative postmenopausal women.
The New York Times on Sunday examined recently unsealed court documents from lawsuits arguing that drugmaker Wyeth oversold the benefits of its menopausal hormone drugs while failing to warn of their risks. Lawyers released some of the documents earlier this year, and the New York Times and the Public Library of Science successfully filed motions to unseal thousands more. According to the Times, the documents paint Wyeth as company that "over several decades, spent tens of millions of dollars on influential physicians, professional medical societies, scientific publications, courses and celebrity ads, inundating doctors and patients with a sea of positive preventive health messages that plaintiffs' lawyers say deflected users' attention from cancer concerns." Over the last seven years, 13, 000 people have sued Wyeth -- absorbed earlier this year by Pfizer -- alleging that Prempro and other hormone drugs caused breast cancer and other health problems. In the mid-1990s, the labels for Wyeth's Prempro and Premarin hormone drugs said that the medications were FDA approved for treating moderate to severe menopause symptoms, such hot flashes, and to prevent osteoporosis.
Postmenopausal women who take antidepressants face a small but statistically significant increased risk for stroke and death compared with those who do not take the drugs. The new findings are from the federally-funded, multi-institution, Women's Health Initiative Study sponsored by the National Institutes of Health, and the results are published in the December 14 online edition of Archives of Internal Medicine. Senior author Sylvia Wassertheil-Smoller, Ph.D., is a principal investigator in the Women's Health Initiative and is division head of epidemiology and professor of epidemiology & population health at Albert Einstein College of Medicine of Yeshiva University. In addition to Einstein, other institutions involved in the study were Massachusetts General Hospital, where the lead author of the paper, Jordan W. Smoller, M.D., Sc.D., is based. He is also associate professor of psychiatry in the Harvard Medical School. Also contributing to the study are researchers from the University of California San Diego, the University of Washington, the University of Hawaii, the University of Iowa, the University of Massachusetts Medical School, and Emory University School of Medicine.
In connection with the New York Times' recent coverage of hormone therapy1, Pfizer Inc. released important facts and context to respond to the newspaper's account. Pfizer believes the coverage is based on a misleading and selective reading of both the science and history of hormone therapy (HT) medicines. Premarin (conjugated estrogens tablets USP) and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), which are approved by the Food and Drug Administration (FDA), have brought relief to tens of millions of women for decades. The FDA has stated that HT has a well-established safety profile and is among the most studied classes of medicines. In addition, the FDA states that HT "is the most effective FDA approved medicine for relief of hot flashes, night sweats or vaginal dryness." A full, fair and accurate report on HT would show: 1. FDA-approved hormone therapy is an important treatment option for certain post-menopausal women. First and most importantly, doctors have been prescribing HT medicines for the treatment of menopausal symptoms (e.