Obstetrics-Gynecology & Women's Health

A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.

4-anilinoquinazoline kinase inhibitor approved in combination with capecitabine for the treatment of advanced or metastatic breast cancer

If your patients are considering hormonal treatment they can also register to receive materials that explain in detail the risk for breast cancer recurrence and how hormonal treatment works. This information will help your patients during your discussions about treatment options.

The Breast Cancer Atlas brings you dozens of clinical, radiographic and histologic images that will transform your presentations and lectures. Each image is accompanied by expert information and perspectives on topical issues, written and reviewed by distinguished editors. With this tool you can select images for your use in presentations, save them in a personal folder, and receive the PowerPoint? file containing your selected images via e-mail.

A randomized, double-blind, placebo-controlled trial published in the Journal of the American Medical Association (JAMA) found that women who discontinued alendronate after 5 years demonstrated a moderate decline in bone mineral density (BMD) and a gradual increase in serum markers of bone turnover compared with women who continued taking alendronate for an additional 5 years, but mean levels among patients who discontinued therapy remained at or above baseline levels measured 10 years earlier. In addition, no greater fracture risk other than for clinically detected vertebral fractures was seen in the discontinuation group compared with patients who continued alendronate for 10 years.

Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).

According to a new study published in the Journal of the National Cancer Institute, menopausal women who use long-term hormone replacement therapy (unopposed estrogen or estrogen in combination with progestin) may have up to a 3-fold increased risk of developing ovarian cancer compared with women who do not use hormone replacement therapy.

The selective estrogen-receptor modulator (SERM) raloxifene reduces the risks of invasive breast cancer and vertebral fracture in postmenopausal women but also increases the risks of venous thromboembolism and fatal stroke, a study in the New England Journal of Medicine (NEJM) concluded.

Raloxifene, a second-generation selective estrogen receptor modulator (SERM) approved to treat osteoporosis, fared as effectively against breast cancer as tamoxifen in 2 related comparison studies published in the Journal of the American Medical Association (JAMA).

An observational cohort study found that the risk of major congenital malformations for infants who were exposed to angiotensin-converting enzyme (ACE) inhibitors during their first trimester increased by a factor of more than 2, while exposure to other antihypertensive medications did not demonstrate an increased risk.

Postmenopausal women with prior hysterectomies do not increase their risk of breast cancer incidence with the use of conjugated equine estrogen (CEE), according to a study published in the Journal of the American Medical Association (JAMA).

Quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine

In a post-hoc analysis, raloxifene (Evista, multiple manufacturers) appeared to attenuate stroke risk caused by high estradiol levels in postmenopausal women, said Jennifer S. Lee, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.

Two recent studies in The New England Journal of Medicine (NEJM) focused on the breast cancer drug trastuzumab, a recombinant monoclonal antibody (Herceptin, Genentech/Roche).

A pivotal phase 3 trial of a fully human monoclonal antibody, denosumab, that prevents bone destruction is under way and includes 7,800 postmenopausal, osteoporotic women aged 60 to 90 years. The primary endpoint is new vertebral fractures versus placebo and secondary end points are safety and tolerability of the new agent. Phase 2 clinical trials have demonstrated that denosumab is superior to aldendronate in preserving bone mineral density (BMD), reported researchers during the American College of Rheumatology Annual Scientific Meeting in San Diego, Calif.

Eszopiclone (Lunesta, Sepracor), a novel, non-benzodiazepine sleep aid, shows significant value in the treatment of insomnia associated with menopause, said Claudio N. Soares, MD, PhD, at the North American Menopause Society's 16th annual meeting in San Diego, Calif.

Results from a phase 3 clinical study demonstrate that a novel transdermal estradiol gel (Bio-E-Gel, BioSante) represents a major improvement in low-dose estrogen therapy, significantly reducing the frequency and severity of hot flashes in menopausal women in a dose-dependent manner at all 3 doses studied, with the low dose being identified as the lowest effective approach, stated James A. Simon, MD, at the North American Menopause Society's 16th annual meeting in San Diego.

The growing trend for women to wait later in life before having their first child has placed many women at a higher risk for difficult conception. There are numerous classes of medications available to assist women who have been diagnosed with infertility.Agents that are used in the treatment of infertility include: clomiphene citrate, aromatase inhibitors, gonadotropins, chorionic gonadotropins, gonadotropin-releasing hormone, gonadotropin-releasing hormone agonists, gonadotropin-releasing hormone antagonists, follitropins, and other miscellaneous agents. Medications chosen for a patient will vary depending on the identified cause of the infertility. Additionally, economic factors will play a role. It is important for healthcare professionals to be aware of treatment options and have a basic understanding of the role these medications play in the treatment of infertility. (Formulary. 2005;40:329–341.)

One year of bisphosphonate therapy maintains the gains in bone mineral density (BMD) experienced after 1 year of full-length parathyroid hormone (1–84) in postmenopausal women at risk of osteoporotic fracture. The findings were published in the New England Journal of Medicine (2005;353:555–565).

According to a study published in the New England Journal of Medicine, short-term use of estrogen plus progestin significantly decreased the risk of colorectal cancer among postmenopausal women; however, for unknown reasons, the colorectal cancers that did develop in the hormone-treated group were diagnosed at a more advanced stage.

Findings from a newly released Women's Health Initiative (WHI) study suggest that conjugated equine estrogen (CEE) alone should not be used for chronic disease prevention, specifically coronary heart disease (CHD), in postmenopausal women. The study, published in the Journal of the American Medical Association, found that CEE increased the risk of stroke by 39% and offered no protection against heart disease.

More than half the women suffering from early-stage breast cancer (ESBC) are at increased risk of recurrence or death because of substantial reductions-planned or unplanned-in relative dose-intensity (RDI) when treated with adjuvant chemotherapy, according to a study published in the Journal of Clinical Oncology.

Disease-free survival in postmenopausal women with primary breast cancer significantly improved when tamoxifen monotherapy treatment was switched to exemestane therapy after 2-3 years, according to a study published in the New England Journal of Medicine. The existing treatment paradigm calls for tamoxifen, an estrogen-receptor modulator, to be taken alone for all 5 years, but some patients have experienced relapse.

Authors Derek Van Amerongen, MD, MS Chief Medical Officer Humana Health Plan of Ohio Cincinnati, Ohio DonnaChiefari, RPH Director, Clinical Services NMHC Rx Latham, NY The views and opinions expressed in this supplement are those of the faculty and do not necessarily reflect the views of Advanstar Communications, Inc., publishers of Formulary, or Barr Laboratories Copyright 2004 Advanstar Communications, Inc., All rights reserved.

Extended use of combination monophasic oral contraceptives (OCs) used to treat women with menstrual disorders, such as endometriosis and dysmenorrhea, has been proven to be safe, effective, and acceptable to women. Even women without a medical indication for menstrual suppression may find that extending OC therapy may yield an improvement in their quality of life by diminishing menstrual symptoms associated with hormone withdrawal during the placebo interval. Most physicians and many women are aware of how to extend OC therapy, and commonly manipulate their cycles to avoid unwanted menstruation at inopportune times, such as during a honeymoon, vacation, or exams.

The oral contraceptive marketplace has undergone evolutionary changes over the years. Early oral contraceptive formulations contained higher doses of estrogen and progestin, which were associated with several safety concerns. Consequently, scientists returned to the laboratories to develop lower-dose formulations that would minimize risk without compromising efficacy. To date, numerous formulations have entered the marketplace that allow for tailored dosing to meet a woman?s clinical and individual needs. In order to provide additional treatment options and create more convenient oral contraceptive regimens, monophasic, multiphasic, extended-cycle, progestin-only, and chewable regimens have emerged. This article will review the main health risks and benefits of oral contraceptives, the concept of extended-cycle regimens, and the financial implications associated with oral contraceptive use.

Extended use of combination monophasic oral contraceptives (OCs) used to treat women with menstrual disorders, such as endometriosis and dysmenorrhea, has been proven to be safe, effective, and acceptable to women. Even women without a medical indication for menstrual suppression may find that extending OC therapy may yield an improvement in their quality of life by diminishing menstrual symptoms associated with hormone withdrawal during the placebo interval. Most physicians and many women are aware of how to extend OC therapy, and commonly manipulate their cycles to avoid unwanted menstruation at inopportune times, such as during a honeymoon, vacation, or exams.

Letrozole therapy, in follow-up to 5 years of tamoxifen treatment, significantly improves disease-free survival compared to placebo, according to a study published in The New England Journal of Medicine.

First extended-cycle oral contraceptive approved

Estrogen plus progestin therapy does not prevent mild cognitive impairment (MCI) in women aged 65 years and older, and it increases the risk for probable dementia in this group, according to researchers from the Women's Health Initiative Memory Study (WHIMS).