{
    "abstract": "To evaluate the safety of daily oral ospemifene 60\u2009mg, estrogen agonist/antagonist, used to treat moderate-to-severe dyspareunia due to postmenopausal vulvovaginal atrophy, which is part of genitourinary syndrome of menopause.\nPost 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\u2009mg on the breast, cardiovascular system, and bone in postmenopausal women.\nAt least one TEAE was reported by 67.6% (840/1242) and 54.1% (518/958) of women taking ospemifene 60\u2009mg 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%).\nNo unexpected safety signals were reported, and discontinuation due to TEAEs was low, with use of ospemifene 60\u2009mg 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.",
    "authors": [
        {
            "affiliation": "1 Women's Health and Research Consultants, Washington, District of Columbia.",
            "firstname": "James A",
            "initials": "JA",
            "lastname": "Simon"
        },
        {
            "affiliation": "2 Shionogi, Inc. , Florham Park, New Jersey.",
            "firstname": "Corrado",
            "initials": "C",
            "lastname": "Altomare"
        },
        {
            "affiliation": "2 Shionogi, Inc. , Florham Park, New Jersey.",
            "firstname": "Susannah",
            "initials": "S",
            "lastname": "Cort"
        },
        {
            "affiliation": "2 Shionogi, Inc. , Florham Park, New Jersey.",
            "firstname": "Wei",
            "initials": "W",
            "lastname": "Jiang"
        },
        {
            "affiliation": "3 Midlife Health Center, Department of Obstetrics and Gynecology, University of Virginia , Charlottesville, Virginia.",
            "firstname": "JoAnn V",
            "initials": "JV",
            "lastname": "Pinkerton"
        }
    ],
    "conclusions": "No unexpected safety signals were reported, and discontinuation due to TEAEs was low, with use of ospemifene 60\u2009mg 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.",
    "copyrights": null,
    "doi": "10.1089/jwh.2017.6385",
    "journal": "Journal of women's health (2002)",
    "keywords": [
        "dyspareunia",
        "estrogen receptor agonist and antagonist",
        "ospemifene",
        "selective estrogen receptor modulator",
        "vulvar and vaginal atrophy"
    ],
    "methods": null,
    "publication_date": "2017-10-25",
    "pubmed_id": "29064335\n19493278\n18698279\n20042564\n25160739\n25944521\n23985562\n23736862\n23731983\n22168244\n23215675\n23571518\n25140698\n20032798\n24977459\n24679891\n23361170\n24411556\n23096251\n23984673\n27404027\n28509812\n27045700\n24108389\n15255284\n16816926\n24109197\n24526372\n14501605\n14501606\n27163517\n20569451\n15458908\n24055829\n23676631\n24918836",
    "results": "At least one TEAE was reported by 67.6% (840/1242) and 54.1% (518/958) of women taking ospemifene 60\u2009mg 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%).",
    "title": "Overall Safety of Ospemifene in Postmenopausal Women from Placebo-Controlled Phase 2 and 3 Trials.",
    "xml": "<Element 'PubmedArticle' at 0x788503858b80>"
}