Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial.
OBJECTIVE
The effects of bazedoxifene (BZA)/conjugated estrogens (CE) on sleep and health-related quality of life (HRQoL) were evaluated in nonhysterectomized postmenopausal women who were enrolled in a randomized, double-blind, placebo- and active-controlled phase 3 trial.


METHODS
The sleep/HRQoL substudy enrolled 459 women with bothersome moderate to severe vasomotor symptoms who were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, BZA 20 mg, CE 0.45 mg/medroxyprogesterone acetate (MPA) 1.5 mg, or placebo for 1 year. On months 3 and 12, sleep parameters were evaluated using the Medical Outcomes Study sleep scale, and HRQoL was assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire.


RESULTS
BZA/CE and CE/MPA significantly improved sleep and HRQoL compared with placebo. On month 3, most Medical Outcomes Study sleep parameter improvements with BZA/CE and CE/MPA versus placebo were not significant. On month 12, both BZA/CE doses and CE/MPA significantly improved time to fall asleep and sleep disturbance (P < 0.05 vs. placebo); BZA 20 mg/CE 0.625 mg and CE/MPA also showed significant improvements in sleep adequacy and sleep problem indices I and II (P < 0.01 vs placebo). Both BZA/CE doses and CE/MPA significantly improved MENQOL vasomotor function score versus placebo at 3 and 12 months (P < 0.001). At 3 months, total MENQOL score was significantly improved with BZA 20 mg/CE 0.625 mg and CE/MPA versus placebo (P < 0.05); at 12 months, both BZA/CE doses and CE/MPA showed significant improvements (P < 0.001).


CONCLUSIONS
Symptomatic postmenopausal women who are treated with BZA/CE for 1 year demonstrate significant improvements in sleep and HRQoL, similar to women treated with CE/MPA.
From the 1Division of Midlife Health Center, Department of Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, VA; 2Pfizer Inc, Collegeville, PA; and 3Pfizer Ltd, Tadworth, Surrey, UK.
Joann V
JV
Pinkerton
Kaijie
K
Pan
Lucy
L
Abraham
Jill
J
Racketa
Kelly A
KA
Ryan
Arkadi A
AA
Chines
Sebastian
S
Mirkin
D004311:Double-Blind Method; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D006304:Health Status; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D008875:Middle Aged; D010919:Placebos; D017698:Postmenopause; D011788:Quality of Life; D012890:Sleep / Q000187:drug effects; D012893:Sleep Wake Disorders / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D004966:Estrogens, Conjugated (USP); D007211:Indoles; D010919:Placebos; D017258:Medroxyprogesterone Acetate; C447119:bazedoxifene