title: Ospemifene's effect on vasomotor symptoms: a post hoc analysis of phase 2 and 3 clinical data.
abstract: To examine the effect of ospemifene 60 mg/d on vasomotor symptoms in postmenopausal women using clinical safety and efficacy data from five phase 2 and 3 studies.
  
  
  
  The incidence of hot flush treatment-emergent adverse events (TEAEs) was compiled from five randomized, placebo-controlled clinical studies; baseline parameters associated with hot flush incidence were also identified. Ospemifene's effects on the frequency and severity of hot flushes were evaluated in a previously unpublished, 6-week, placebo-controlled study.
  
  
  
  Analysis of pooled hot flush TEAE data for 2,166 women showed an incidence of hot flush of 8.5% for ospemifene and 3.2% for placebo (P < 0.0001). Hot flushes were most frequent during the first 4 weeks of ospemifene treatment and decreased in frequency thereafter. Logistic regression analysis revealed that hormone therapy within 6 months before study start (P = 0.0234), longer study treatment duration (P = 0.0234), and more hot flush days per month at baseline (P = 0.0313) were associated with more hot flushes. Ospemifene 60 mg/d did not worsen the frequency and severity of existing hot flushes in a 6-week, placebo-controlled trial of 198 postmenopausal women who were experiencing moderate to very severe hot flushes.
  
  
  
  In randomized trials, hot flush TEAEs were more frequent with ospemifene 60 mg/d than with placebo, particularly among women with prior history of hormone therapy use. The majority of hot flushes, however, waned after 4 weeks of ospemifene treatment. Ospemifene did not worsen existing hot flushes in women experiencing moderate to very severe hot flushes.
authors.affiliation: 1EndoRheum Consultants, Malvern, PA 2Jones Institute for Reproductive Medicine, Norfolk, VA 3California Pacific Medical Center, San Francisco, CA 4Shionogi, Inc, Florham Park, NJ 5University of Virginia, Charlottesville, VA.
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.forename: Ricki
authors.initials: R
authors.lastname: Pollycove
authors.forename: Wei
authors.initials: W
authors.lastname: Jiang
authors.forename: Corrado
authors.initials: C
authors.lastname: Altomare
authors.forename: JoAnn V
authors.initials: JV
authors.lastname: Pinkerton
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D013629:Tamoxifen / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014666:Vasomotor System / Q000187:drug effects*
chemical_list: D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene