PMID- 29064335
OWN - NLM
STAT- MEDLINE
DCOM- 20180906
LR  - 20181113
IS  - 1931-843X (Electronic)
IS  - 1540-9996 (Print)
IS  - 1540-9996 (Linking)
VI  - 27
IP  - 1
DP  - 2018 Jan
TI  - Overall Safety of Ospemifene in Postmenopausal Women from Placebo-Controlled 
      Phase 2 and 3 Trials.
PG  - 14-23
LID - 10.1089/jwh.2017.6385 [doi]
AB  - 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.
FAU - Simon, James A
AU  - Simon JA
AD  - 1 Women's Health and Research Consultants, Washington, District of Columbia.
FAU - Altomare, Corrado
AU  - Altomare C
AD  - 2 Shionogi, Inc. , Florham Park, New Jersey.
FAU - Cort, Susannah
AU  - Cort S
AD  - 2 Shionogi, Inc. , Florham Park, New Jersey.
FAU - Jiang, Wei
AU  - Jiang W
AD  - 2 Shionogi, Inc. , Florham Park, New Jersey.
FAU - Pinkerton, JoAnn V
AU  - Pinkerton JV
AD  - 3 Midlife Health Center, Department of Obstetrics and Gynecology, University of 
      Virginia , Charlottesville, Virginia.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20171024
PL  - United States
TA  - J Womens Health (Larchmt)
JT  - Journal of women's health (2002)
JID - 101159262
RN  - 0 (Estrogen Antagonists)
RN  - 0 (Placebos)
RN  - 094ZI81Y45 (Tamoxifen)
RN  - B0P231ILBK (Ospemifene)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Atrophy/pathology
MH  - Bone and Bones/*drug effects
MH  - Breast/*drug effects
MH  - Cardiovascular System/*drug effects
MH  - Double-Blind Method
MH  - Dyspareunia/*drug therapy/etiology
MH  - Estrogen Antagonists/*therapeutic use
MH  - Female
MH  - Hot Flashes/chemically induced
MH  - Humans
MH  - Middle Aged
MH  - Placebos
MH  - *Postmenopause
MH  - Tamoxifen/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Treatment Outcome
MH  - Vagina/*drug effects/pathology
MH  - Vulva/*drug effects/pathology
PMC - PMC5771532
OTO - NOTNLM
OT  - dyspareunia
OT  - estrogen receptor agonist and antagonist
OT  - ospemifene
OT  - selective estrogen receptor modulator
OT  - vulvar and vaginal atrophy
COIS- Dr. Simon has served (within the last year) or is currently serving as a 
      consultant to or on the advisory boards of AbbVie, Allergan, AMAG, Amgen, Inc., 
      Apotex, Inc., Ascend Therapeutics, Azure Biotech, JDS Therapeutics, Merck & Co, 
      Millendo Therapeutics, Noven, Novo Nordisk, Nuelle, Perrigo Company, PLC, Radius 
      Health, Regeneron Pharmaceuticals, Roivant Sciences, Sanofi SA, Sebela 
      Pharmaceuticals, Sermonix Pharmaceuticals, Shionogi, Inc., Sprout 
      Pharmaceuticals, Symbiotec Pharmalab, TherapeuticsMD, and Valeant 
      Pharmaceuticals; and has received (within the last year) or is currently 
      receiving grant/research support from AbbVie, Actavis, PLC, Agile Therapeutics, 
      Bayer Healthcare, GlaxoSmithKline, New England Research Institute, Novo Nordisk, 
      Palatin Technologies, Symbio Research, and TherapeuticsMD; and has also served 
      (within the last year) or is currently serving on the speaker's bureaus of Amgen, 
      Eisai, Merck, Noven Pharmaceuticals, Novo Nordisk, Shionogi, Inc., and Valeant 
      Pharmaceuticals; and is a stockholder (direct purchase) in Sermonix 
      Pharmaceuticals. Drs. Altomare, Cort, and Jiang are employees of Shionogi, Inc. 
      Dr. Pinkerton has served as a consultant (fees paid to the University of 
      Virginia) for Pfizer, Inc., and in-kind editorial support from Pfizer, Noven 
      Pharmaceuticals, Inc., TherapeuticsMD, and Shionogi, Inc.; has received 
      grants/research support (fees paid to the University of Virginia) from 
      TherapeuticsMD.
EDAT- 2017/10/25 06:00
MHDA- 2018/09/07 06:00
PMCR- 2018/01/01
CRDT- 2017/10/25 06:00
PHST- 2017/10/25 06:00 [pubmed]
PHST- 2018/09/07 06:00 [medline]
PHST- 2017/10/25 06:00 [entrez]
PHST- 2018/01/01 00:00 [pmc-release]
AID - 10.1089/jwh.2017.6385 [pii]
AID - 10.1089/jwh.2017.6385 [doi]
PST - ppublish
SO  - J Womens Health (Larchmt). 2018 Jan;27(1):14-23. doi: 10.1089/jwh.2017.6385. Epub 
      2017 Oct 24.