title: A Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Lipid Parameters in Postmenopausal Women From the Selective Estrogens, Menopause, and Response to Therapy (SMART) Trials.
abstract: BACKGROUND
  Menopausal lipid profile changes may increase cardiovascular risk. The effects of conjugated estrogens (CE)/bazedoxifene (BZA), an approved menopausal therapy, on lipids have not been fully characterized.
  
  
  OBJECTIVE
  The purpose of this study was to determine the effects of CE/BZA on lipids in the Selective estrogens, Menopause, And Response to Therapy (SMART) trials for ≥ 1 year.
  
  
  METHODS
  This was a pooled analysis of 3 randomized, double-blind, placebo (PBO)-controlled phase 3 trials (SMART-1, -4, and -5).
  
  
  METHODS
  The study was conducted in North America, Europe, Asia-Pacific Region, and Latin America.
  
  
  METHODS
  Participants were nonhysterectomized postmenopausal women aged 40 to 75 years, not taking lipid-lowering medications (N = 2796).
  
  
  METHODS
  Treatments were CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, and PBO.
  
  
  METHODS
  The adjusted mean percentage changes from baseline in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, and the LDL-C/HDL-C ratio at 12 and 24 months were measured.
  
  
  RESULTS
  At 12 months, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg produced significant (P < .001) improvements vs PBO in TC (-4.20% and -4.37% vs -0.88%), LDL-C (-9.33% and -10.78% vs -1.08%), HDL-C (4.59% and 6.21% vs 1.30%), and the LDL-C/HDL-C ratio (-11.59% and -14.00% vs -0.84%). Triglycerides were significantly (P < .001) increased from baseline with both doses vs PBO (15.13% and 15.74% vs 4.43%). Similar trends (all P < .001) were seen at 24 months when SMART-1 and SMART-4 were pooled (TC: -3.25% and -3.13% vs 0.95%; LDL-C: -7.47% and -8.08% vs 2.95%; HDL-C: 5.91% and 7.19% vs 1.72%; triglycerides: 18.87% and 18.82% vs 6.49%; and the LDL-C/HDL-C ratio: -10.05% and -12.82% vs 2.56%).
  
  
  CONCLUSIONS
  CE/BZA was associated with mostly favorable changes in lipid parameters for up to 2 years in nonhysterectomized postmenopausal women.
authors.forename: John C
authors.initials: JC
authors.lastname: Stevenson
authors.forename: Arkadi
authors.initials: A
authors.lastname: Chines
authors.forename: Kaijie
authors.initials: K
authors.lastname: Pan
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Ryan
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
mesh_terms: D000328:Adult; D000368:Aged; D015914:Estrogen Replacement Therapy / Q000379:methods; D004966:Estrogens, Conjugated (USP) / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007211:Indoles / Q000494:pharmacology*; D050356:Lipid Metabolism / Q000187:drug effects; D008055:Lipids / Q000097:blood*; D008593:Menopause / Q000097:blood / Q000187:drug effects*; D008875:Middle Aged; D017698:Postmenopause / Q000097:blood / Q000187:drug effects; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D020845:Selective Estrogen Receptor Modulators / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D004966:Estrogens, Conjugated (USP); D007211:Indoles; D008055:Lipids; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene