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      Overall Safety of Ospemifene in Postmenopausal Women from Placebo-Controlled Phase 2 and 3 Trials

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          Abstract

          Objective: To evaluate the safety of daily oral ospemifene 60 mg, estrogen agonist/antagonist, used to treat moderate-to-severe dyspareunia due to postmenopausal vulvovaginal atrophy, which is part of genitourinary syndrome of menopause.

          Methods: Post hoc analysis of safety data (treatment-emergent adverse events [TEAEs]) pooled from six phase 2 and 3 randomized, double-blind, multicenter placebo-controlled studies, evaluating the effects of ospemifene 60 mg on the breast, cardiovascular system, and bone in postmenopausal women.

          Results: At least one TEAE was reported by 67.6% (840/1242) and 54.1% (518/958) of women taking ospemifene 60 mg and placebo, respectively. Most TEAEs were mild or moderate and occurred within 4 to 12 weeks. The most commonly reported TEAEs with ospemifene were hot flush (8.5% vs. 3.3% for placebo) and urinary tract infection (6.5% vs. 4.8%). Discontinuation due to TEAEs was 7.6% with ospemifene and 3.8% with placebo. Most women discontinued treatment due to adverse events (AEs): hot flushes, muscle spasms, headache, and vaginal discharge. Serious AEs occurred infrequently (ospemifene, 2.6%; placebo, 1.8%); most were not considered related to treatment. Breast cancer and other breast-related TEAE incidences were comparable between ospemifene (2.5%) and placebo (2.2%), and cardiovascular TEAE incidence, including deep vein thrombosis, was low with ospemifene (0.3%) and placebo (0.1%).

          Conclusion: No unexpected safety signals were reported, and discontinuation due to TEAEs was low, with use of ospemifene 60 mg versus placebo in six phase 2 and 3 trials, suggesting a lack of detrimental effects on the breast, bone, and cardiovascular health of postmenopausal women when ospemifene is used to effectively treat moderate-to-severe postmenopausal dyspareunia.

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          Most cited references33

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          Vulvovaginal atrophy.

          Vulvovaginal atrophy (VVA) is a common and underreported condition associated with decreased estrogenization of the vaginal tissue. Symptoms include dryness, irritation, soreness, and dyspareunia with urinary frequency, urgency, and urge incontinence. It can occur at any time in a woman's life cycle, although more commonly in the postmenopausal phase, during which the prevalence is close to 50%. Clinical findings include the presence of pale and dry vulvovaginal mucosa with petechiae. Vaginal rugae disappear, and the cervix may become flush with the vaginal wall. A vaginal pH of 4.6 or more supports the diagnosis of VVA. Even while taking systemic estrogen, 10% to 20% of women may still have residual VVA symptoms. Breast cancer treatment increases the prevalence of VVA because the surgical, endocrine, and chemotherapeutic agents used in its treatment can cause or exacerbate VVA. Local estrogen treatment for this group of women remains controversial.
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            Prevalence and impact of vaginal symptoms among postmenopausal women.

            Vulvovaginal atrophy (VVA) is reported by one-quarter to one-half of postmenopausal women. We evaluated the prevalence, inconvenience of, and issues surrounding hormone use for VVA symptoms in women who were current, past, and never users of menopausal hormone therapy (MHT), along with the relationship of sexual activity to VVA symptoms. An online survey was sent to 3,471 women >or=45 years old participating in a panel of approximately 43,000 U.S. adults maintained by Knowledge Networks. Respondents were stratified by MHT use (current, past, and never) and sexual activity (sexually active and not sexually active). Final respondent data underwent a poststratification process and Chi-square analysis of hormone use and VVA by sexual activity. Main Outcome Measures. Percent, calculated as the ratio of response over total responding for each survey question for all and stratified respondents. Forty-five percent (1,038/2,290) of respondents (age range 45-89 years; mean 60.7 years) were postmenopausal and currently or previously experienced VVA. Approximately 60% of past or never users of MHT reported vaginal symptoms; >90% found them bothersome. In comparison, 82% of current users reported VVA symptoms prior to use. 85% of all respondents were aware of safety issues associated with MHT. The prevalence and perceived severity of VVA symptoms were substantial but less frequent in nonsexually active women. Analysis of MHT use by past or current hormone use indicated a trend away from oral dosing and towards patch or vaginal hormones. Postmenopausal women have a high rate of VVA symptoms. Those who use MHT do so for multiple reasons-hot flashes, VVA, bone protection, dyspareunia-and most have concerns about long-term safety, despite the fact that the majority of MHT use was for >5 years. Safety concerns and lack of physician recommendation were major reasons for not using or discontinuing MHT.
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              Vaginal Health: Insights, Views & Attitudes (VIVA) - results from an international survey.

              To assess knowledge of vaginal atrophy among women using the Vaginal Health: Insights, Views & Attitudes (VIVA) survey. A structured online questionnaire was used to obtain information from 3520 postmenopausal women aged 55-65 years living in Great Britain, the United States, Canada, Sweden, Denmark, Finland, and Norway. In total, 45% of women reported experiencing vaginal symptoms. Only 4% of women attributed these symptoms to vaginal atrophy, and 63% failed to recognize vaginal atrophy as a chronic condition. Overall, 44% of respondents did not have a gynecologist, but this percentage varied between countries. Most women (75%) felt that vaginal atrophy had a negative impact on life, but this perception also showed country-specific differences. Most Finnish respondents (76%) were satisfied with the amount of information available about vaginal atrophy, compared with just 37-42% of women from other countries. Most women used over-the-counter products for vaginal atrophy symptoms, but specific means of treating the underlying cause were less well known. Almost half (46%) of all respondents lacked knowledge about local estrogen therapy, with women in Great Britain, the United States and Canada being most likely to lack knowledge of such treatment. Overall, 30% of women would consider taking local estrogen therapy, with vaginal tablets being the preferred option in all countries. Postmenopausal women have a low understanding of vaginal atrophy. Medical practitioners should proactively raise this topic, help patients to understand that vaginal atrophy is a chronic condition, and discuss treatment options. Country-specific approaches may be required.
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                Author and article information

                Journal
                J Womens Health (Larchmt)
                J Womens Health (Larchmt)
                jwh
                Journal of Women's Health
                Mary Ann Liebert, Inc. (140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA )
                1540-9996
                1931-843X
                01 January 2018
                01 January 2018
                01 January 2018
                : 27
                : 1
                : 14-23
                Affiliations
                [ 1 ]Women's Health and Research Consultants , Washington, District of Columbia.
                [ 2 ]Shionogi, Inc. , Florham Park, New Jersey.
                [ 3 ]Midlife Health Center, Department of Obstetrics and Gynecology, University of Virginia , Charlottesville, Virginia.
                Author notes
                Address correspondence to: James A. Simon, MD, Women's Health and Research Consultants 1850M Street, NW, Suite 450, Washington, DC 20036, E-mail: jsimon@ 123456jamesasimonmd.com
                Article
                10.1089/jwh.2017.6385
                10.1089/jwh.2017.6385
                5771532
                29064335
                1d63acce-de42-4490-be8e-671a4e8944b4
                © James A. Simon et al. 2017; Published by Mary Ann Liebert, Inc.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Mary Ann Liebert, Inc. offers reprint services for those who want to order professionally produced copies of articles published under the Creative Commons Attribution (CC BY) license. To obtain a price quote, email Reprints@liebertpub.com. Please include the article's title or DOI, quantity, and delivery destination in your email.

                History
                Page count
                Figures: 1, Tables: 5, References: 37, Pages: 10
                Categories
                Original Articles

                dyspareunia,ospemifene,estrogen receptor agonist and antagonist,selective estrogen receptor modulator,vulvar and vaginal atrophy

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