Journal of women's health
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Journal of women's health · Oct 2018
Working Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference Symposium.
Historically, women have been underrepresented in clinical research, requiring physicians to extrapolate medical recommendations for women from clinical research done in cohorts consisting predominantly of male participants. While government-funded clinical research has achieved gender parity in phase-3 clinical trials across many biomedical disciplines, improvements are still needed in several facets of women's health research, such as the inclusion of women in early-phase clinical trials, the inclusion of pregnant women and women with physical and intellectual disabilities, the consideration of sex as a biological variable in preclinical research, and the analysis and reporting of sex and gender differences across the full biomedical research continuum. The National Institutes of Health (NIH) Office of Research on Women's Health and the Office of Women's Health of the U. ⋯ Six speakers presented information on a range of subjects related to the representation of women in clinical research and federal initiatives to advance precision medicine. Topics included the following: the return on investment from the NIH-funded Women's Health Initiative; progress in including women in clinical trials for FDA-approved drugs and products; the importance of clinical trials in pregnant women; FDA initiatives to report drug safety during pregnancy; the NIH-funded All of Us Research Program; and efforts to enhance FDA transparency and communications, including the introduction of Drug Trials Snapshots. This article summarizes the major points of the presentations and the discussions that followed.
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Journal of women's health · Sep 2018
Prolonged Amenorrhea and Resumption of Menses in Women with HIV.
To compare etiologies of prolonged amenorrhea in a cohort of HIV-infected women with a cohort of similar uninfected at-risk women. ⋯ Women with HIV infection have unexplained prolonged amenorrhea more often than at-risk seronegative women. This is especially common among obese, less-educated women. Prolonged amenorrhea in the HIV-seropositive women should be evaluated and not be presumed to be to the result of menopause.
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Journal of women's health · Sep 2018
Differences in Screening and Treatment for Antepartum Versus Postpartum Patients: Are Providers Implementing the Guidelines of Care for Perinatal Depression?
National guidelines recommend universal depression screening for perinatal patients and provide treatment recommendations to prevent adverse maternal/child health outcomes. However, providers rarely screen all patients, and most women with perinatal depression remain undertreated. This study investigated predictors of universal screening and guideline-congruent care for perinatal depression by obstetrician-gynecologists and examined differences in practices with pregnant and postpartum patients. ⋯ This study displays differences in perinatal depression care for pregnant and postpartum patients, particularly disparities for pregnant patients. The findings highlight facilitating factors for translating guidelines into routine practices.
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Journal of women's health · Sep 2018
Randomized Controlled TrialLipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis.
High triglycerides (TG) and diabetes mellitus type 2 (DM2) are stronger predictors of cardiovascular disease (CVD) in women than in men, but few randomized, controlled clinical trials have investigated lipid-lowering interventions in women and none have reported results specifically in women with high TG and DM2. Icosapent ethyl (Vascepa) is pure prescription eicosapentaenoic acid (EPA) ethyl ester approved at 4 g/day as an adjunct to diet to reduce TG ≥500 mg/dL. ⋯ In women with DM2 at high CVD risk with persistently high TG on statins, icosapent ethyl 4 g/day reduced potentially atherogenic parameters with safety and tolerability comparable to placebo. Potential CVD benefits of icosapent ethyl are being tested in ∼8000 men and women at high CVD risk with high TG on statins in the ongoing Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial (REDUCE-IT) cardiovascular (CV) outcome trial.
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In postmenopausal women, osteoporotic fractures are more common than stroke, myocardial infarction, and breast cancer combined, and fractures can be costly and result in disability or death. Because there are no signs or symptoms of osteoporosis other than fracture, risk assessment is necessary to identify those at higher risk for clinical events. For women, a clinical fracture risk assessment (FRAX) is appropriate at menopause. ⋯ Anabolic therapy can be offered to those with higher risk for fracture. Although rare safety concerns regarding atypical femoral fracture and osteonecrosis of the jaw have received prominent attention, for patients who are appropriately treated according to National Osteoporosis Foundation guidelines, the benefit of hip fracture risk reduction far outweighs the risk of these uncommon side effects. Accurate information for patients and shared decision-making are important for acceptance and persistent with appropriate treatment.