This study characterizes and quantifies the relationship of vasomotor symptoms (VMS) of menopause with menopause-specific quality of life (MSQOL) and sleep parameters to help predict treatment outcomes and inform treatment decision-making.
Data were derived from a 12-week randomized, double-blind, placebo-controlled phase 3 trial that evaluated effects of two doses of conjugated estrogens/bazedoxifene on VMS in nonhysterectomized postmenopausal women (N = 318, mean age = 53.39) experiencing at least seven moderate to severe hot flushes (HFs) per day or at least 50 per week. Repeated measures models were used to determine relationships between HF frequency and severity and outcomes on the Menopause-Specific Quality of Life questionnaire and the Medical Outcomes Study sleep scale. Sensitivity analyses were performed to check assumptions of linearity between VMS and outcomes.
Frequency and severity of HFs showed approximately linear relationships with MSQOL and sleep parameters. Sensitivity analyses supported assumptions of linearity. The largest changes associated with a reduction of five HFs and a 0.5-point decrease in severity occurred in the Menopause-Specific Quality of Life vasomotor functioning domain (0.78 for number of HFs and 0.98 for severity) and the Medical Outcomes Study sleep disturbance (7.38 and 4.86) and sleep adequacy (−5.60 and −4.66) domains and the two overall sleep problems indices (SPI: 5.17 and 3.63; SPII: 5.82 and 3.83).
Frequency and severity of HFs have an approximately linear relationship with MSQOL and sleep parameters—that is, improvements in HFs are associated with improvements in MSQOL and sleep. Such relationships may enable clinicians to predict changes in sleep and MSQOL expected from various VMS treatments.
1University of Virginia Health System, Charlottesville, VA
2Pfizer Ltd, Tadworth, Surrey, UK
3Pfizer Inc, Groton, CT
4Pfizer Inc, Collegeville, PA.
Address correspondence to: Lucy Abraham, MSc, CPsychol, Director, Outcomes & Evidence, Global Health and Value, Pfizer Ltd, Walton Oaks, Dorking Road, Walton on the Hill, Tadworth, Kent, Surrey KT20 7NS, UK. E-mail: Lucy.Abraham@pfizer.com
Received 23 October, 2015
Revised 9 March, 2016
Accepted 9 March, 2016
Funding/support: This study was sponsored by Pfizer Inc. Medical writing support was provided by Nicole Cooper and Lauren Cerruto of Peloton Advantage, and was funded by Pfizer Inc.
Financial disclosure/conflicts of interest: J.V.P. (all fees to the University of Virginia) has served as a consultant for Pfizer Inc; has received grants/research support from TherapeuticsMD; has received travel funds for consulting from Pfizer Inc; and has received editorial writing support from Pfizer Inc, TherapeuticsMD, Shionogi, and Noven Pharmaceuticals. A.G.B., J.C.C., and B.S.K. are employees and stockholders of Pfizer Inc. L.A. is an employee and shareholder of Pfizer Ltd.