News
Article Outline
- Article Outlines Seven Most Commonly Missed Diagnoses in Women
- Birth Control Pill Use May Decrease Urinary Incontinence Risk
- Report Finds Breast Cancer Drugs Can Cause Other Problems
- Experts Seek New Name for Women's Heart Disease
- Statins for Apparently Healthy Women Can Reduce Risk for CV Events
- FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
Guides Help Consumers, Clinicians Compare Treatments for Gestational Diabetes
The Agency for Healthcare Research and Quality (AHRQ) released two new guides that can help women with gestational diabetes and their providers make informed decisions about different treatments for the condition. The guides provide the latest scientific evidence on the effectiveness and safety of drugs for gestational diabetes, a potentially dangerous condition that affects 7 of 100 pregnant women.
Gestational diabetes disappears after childbirth, but 5% of women who had it during pregnancy develop type 2 diabetes within 6 months and 60% within 10 years. The consumer guide, “Gestational Diabetes: A Guide for Pregnant Women,” presents treatment options, including diet, insulin, or the oral diabetes medicines glyburide or metformin, and gives women advice on what they should do after pregnancy, such as having their blood glucose level monitored regularly, since they have a higher risk of developing type 2 diabetes. Get the PDF at effectivehealthcare.ahrq.gov/repfiles/2009_0804GDM_Cons_singlpgs.pdf.
The clinician's guide, “Gestational Diabetes: Medications, Delivery, and Development of Type 2 Diabetes,” covers these topics, provides an at-a-glance clinical bottom line for managing patients, along with ratings of the evidence for each treatment, a list of risk factors that may mean a woman is likely to develop type 2 diabetes, and other information on helping patients manage gestational diabetes. Get the PDF at effectivehealthcare.ahrq.gov/repfiles/2009_0804GDM_Clinician_final.pdf.
Print copies are available by sending an e-mail to ahrqpubs@ahrq.hhs.gov.
Evidence Report on the Treatment of Overactive Bladder in Women
AHRQ released an evidence report, “Treatment of Overactive Bladder in Women,” which finds drug therapy and behavior interventions produce modest results in reducing overactive bladder symptoms. Quality of life and satisfaction measures suggest such improvements can be important to women.
The review was conducted by AHRQ's Vanderbilt University Evidence-based Practice Center in Nashville and was requested by the American Urological Association. The research, led by Katherine Hartmann, MD, PhD, reviewed evidence on treatments for overactive bladder, including prescription medications, both pills and patches; surgeries and procedures; behavior interventions; and complementary and alternative medicine, such as acupuncture, hypnotherapy and reflexology. Behavioral interventions, which may include pelvic muscle exercises and training the bladder by steadily increasing the time between bathrooms visits, are modestly effective in reducing incontinence associated with overactive bladder syndrome. The results produced by these behavior modifications are similar to the impact of drug therapy. Drug therapy was found to be modestly effective at improving one or more overactive bladder symptoms; however, there is no evidence to determine the drugs' long-term effectiveness.
Researchers found little evidence to support the effectiveness of complementary and alternative therapies. Procedural and surgical treatments, such as sacral nerve stimulation (neuromodulation), and bladder instillation or injections were found to treat symptoms in select groups of women, although more information is needed to understand safety and effectiveness. Read the report at http://www.ahrq.gov/clinic/tp/bladdertp.htm.
AHRQ Report Shows Vaginal Birth after Cesarean is Safe for Most Women
The AHRQ has released a new report that found that vaginal birth after cesarean section is a safe and reasonable choice for a majority of women. Each year, more than 1 million cesarean surgeries are performed, and in 2007, nearly 1 in 3 U.S. births was cesarean. A steady increase in repeat cesarean births over the past decade has been attributed, in part, to studies that suggested there may be significant harms associated with vaginal birth after cesarean section. Investigators in this report found evidence that showed that while rare, maternal mortality was significantly higher for elective repeat cesarean versus trial of labor. Additionally, risks for uterine rupture and perinatal death remain rare but are elevated for trial of labor.
Other important outcomes, such as hemorrhage/transfusion, adhesions, surgical injury, and wound complications, remain uncertain because of a lack of consistent definition and reporting. Moreover, investigators also found increasing evidence that women with multiple cesarean deliveries were at significant risk of life-threatening conditions.
Researchers noted that evidence-based research regarding factors, such as medical liability, economics, and hospital staffing, that may influence patient, provider, and hospital-related decisions between both types of delivery is not sufficient. The report, “Vaginal Birth After Cesarean: New Insights,” was conducted by AHRQ's Oregon Health and Science University Evidence-based Practice Center and was prepared for the NIH Consensus Development Conference held March 8–10.
Article Outlines Seven Most Commonly Missed Diagnoses in Women
In October, Health.com published an article on the seven women's health problems that are the most likely to be overlooked by primary care providers. Here is a list of those conditions. The article explains what each condition is, who gets it, how it feels, how it is diagnosed, and how it is treated (http://www.cnn.com/2009/HEALTH/10/19/undiagnosed.women.problem/index.html).
Birth Control Pill Use May Decrease Urinary Incontinence Risk
A 2009 study from Sweden revealed that users of oral contraception had significantly reduced rates of urinary incontinence than women who used other forms of contraception. Researchers at the Karolinska Institute and at Gothenburg University used the Swedish Twin Registry to examine the relationship between the use of oral contraceptives and urinary incontinence. After using statistical methods to control for factors such as age, body mass index, and previous pregnancy, the data showed that the women who had used oral contraceptives had lower rates of lower urinary tract symptoms than nonusers.
“With so many women using oral contraceptives, it is vital that we continue to fully understand their non-contraceptive effects, both positive and negative. This kind of research will help us better advise our patients as they make decisions about contraception, or possibly seek to avoid urinary tract problems,” said Dale McClure, MD, president of the American Society for Reproductive Medicine.
Report Finds Breast Cancer Drugs Can Cause Other Problems
Three drugs, including tamoxifen, reduce a woman's chance of getting breast cancer, but each drug carries distinct potential harms of its own, according to a report last fall by the Agency for Healthcare Research and Quality (AHRQ). Drugs to reduce the risk of breast cancer can be prescribed to women with a family history of breast cancer or other risk factors, but prescribing practices vary widely. The comparative effectiveness review found that all three drugs—tamoxifen, raloxifene, and tibolone—significantly reduce invasive breast cancer in midlife and older women who have not previously had breast cancer. However, the benefits and adverse effects can vary, depending on the drug and the patient. “Comparative Effectiveness of Medications to Reduce Risk of Primary Breast Cancer in Women” is the first report to make a direct, comprehensive comparison of the drugs so that women and their health care providers can assess the medications' potential effectiveness and adverse effects.
Tamoxifen, a selective estrogen receptor modulator (SERM), was approved by the U.S. Food and Drug Administration (FDA) in 1998 to prevent breast cancer in women at high risk of developing the disease. Its use to reduce the risk of breast cancer is accepted clinical practice, although the drug is primarily used for treatment rather than risk reduction. Raloxifene, another SERM, is used primarily to prevent and treat osteoporosis and was approved by the FDA for breast cancer risk reduction in 2007. The third drug, tibolone, has not been approved by the FDA for use in the United States but is used in other countries to treat menopausal symptoms and osteoporosis. The most common side effects of tamoxifen are flushing and other vasomotor symptoms (e.g., night sweats and hot flashes), vaginal discharge, and other vaginal symptoms such as itching or dryness. Raloxifene side effects include vasomotor symptoms and leg cramps; tibolone side effects include vaginal bleeding.
Adverse effects of tamoxifen include a greater risk for endometrial cancer, hysterectomies, and cataracts than with the other drugs. Tamoxifen and raloxifene increase risk of blood clots, although tamoxifen's risk is greater. Tibolone carries an increased risk of stroke. The report also examined the drugs' effectiveness and harms based on such factors as age, menopausal status, estrogen use, and family history of breast cancer, and sought to identify the kinds of women who might be good candidates for prevention therapy, although the evidence is limited in this area.
Experts Seek New Name for Women's Heart Disease
A collection of cardiologists are lobbying for a new term for a cardiac condition, preferring ischemic heart disease over coronary heart disease for women. Noting that women experience heart illness quite differently from men, the Women's Ischemia Syndrome Evaluation believes changing the focus of care will improve outcomes. The study group includes Dr. C. Noel Bairey Merz, director of the Women's Heart Center at the Cedars-Sinai Heart Institute.
According to a Los Angeles Times article on October 12, 2009, the group “points out that the current focus of treatment for heart disease centers on obstructive coronary artery disease… However, women have less obstructive disease but higher rates of ischemia, which is defined as the inadequate flow of blood through the body because of constriction or blockage in blood vessels. Women with heart disease have more microvascular dysfunction, affecting the small blood vessels of the body, compared with men.”
Furthermore, “Women tend to experience worse outcomes than men because the focus is on obstructive heart disease. A name change may help doctors tailor diagnostic tests and treatments to better suit their patients, both men and women.”
Read the full article at http://latimesblogs.latimes.com/booster_shots/2009/10/heart-disease-women.html.
Statins for Apparently Healthy Women Can Reduce Risk for CV Events
Researchers from Brigham and Women's Hospital's Center for Cardiovascular Disease Prevention, analyzing data from the landmark JUPITER trial, found that women with acceptable levels of low-density lipoprotein (LDL) but elevated high sensitivity C-reactive protein levels (hsCRP; a biomarker for inflammation) benefitted from a daily regimen of rosuvastatin. Compared to women in the study who were given placebo, women receiving statin therapy nearly halved their risk for cardiovascular disease, a risk reduction amount similar to those found among men in the study. The findings appeared in the February 22, 2010, online edition of Circulation.
According to a press release on the hospital center's website, “The JUPITER findings were also compared to a meta-analysis of five peer-reviewed, randomized, placebo-controlled statin trials. Put in context with this material, the women on statin therapy from the meta-analysis had a one-third reduced risk of CVD compared to those taking a placebo.”
Furthermore, “For this research, 6,801 female participants in the JUPITER study who did not have cardiovascular disease, were older than 60 with acceptable levels of LDL cholesterol, and had elevated hsCRP were randomized to receive rosuvastatin or placebo. Among the group receiving rosuvastatin, the researchers found cardiovascular events such as heart attack, stroke, unstable angina, and revascularization were reduced by 46% compared to women in the study who received the placebo. Previous findings from JUPITER showed men on resovastatin therapy reduced their CVD risks by 42% compared to men in the study taking the placebo.”
Samia Mora, MD, lead author of the study and a center researcher, said, “Our findings show for the first time that apparently healthy women with acceptable cholesterol levels but higher hsCRP would benefit from statin therapy. We now have a new tool to better protect women from the risks of cardiovascular disease, since more women die each year from cardiovascular disease than all cancers combined.”
FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
In the Fall of 2009, the U.S. Food and Drug Administration (FDA) approved Lysteda tablets (tranexamic acid), the first nonhormonal product approved to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. About 3 million women of reproductive age report heavy menstrual bleeding each year. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition. “Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, MD, FDA's associate commissioner of women's health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”
Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and after tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood-clotting factor.
The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).
Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. Women using hormonal contraception should take Lysteda only if there is a strong medical need and if the benefit of treatment will outweigh the potential increased risk.
PII: S1555-4155(10)00221-7
doi:10.1016/j.nurpra.2010.04.007
