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Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial

Pinkerton, JoAnn V. MD1; Pan, Kaijie MS2; Abraham, Lucy CPsychol3; Racketa, Jill MS2; Ryan, Kelly A. BSN, MS2; Chines, Arkadi A. MD2; Mirkin, Sebastian MD2

doi: 10.1097/GME.0b013e31829f0433
Original Articles

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.

Received March 6, 2013; revised and accepted May 31, 2013.

J.R. and A.A.C. are no longer affiliated with Pfizer Inc.

Funding/support: This study was sponsored by Wyeth Research, which was acquired by Pfizer in October 2009. Medical writing support was provided by Katie Gersh, PhD (MedErgy), and funded by Pfizer.

Financial disclosure/conflicts of interest: In the past 12 months, J.V.P. has served as a consultant (fees to the University of Virginia) to Pfizer Inc, Noven Pharmaceuticals, Shionogi, and DepoMed. She has received grants/research support (fees to the University of Virginia) from DepoMed, Bionovo, and Endoceutics, and travel funds from Pfizer Inc, Noven Pharmaceuticals, Shionogi, and DepoMed. K.P., L.A., K.A.R., and S.M. are employees of Pfizer. J.R. and A.A.C. are former employees of Pfizer.

Address correspondence to: JoAnn V. Pinkerton, MD, Box 801104, University of Virginia Health System, Charlottesville, VA 22908. E-mail: jvp9u@virginia.edu

© 2014 by The North American Menopause Society.