Hot flush symptom-free days with bazedoxifene/conjugated estrogens in postmenopausal women

ABSTRACT

Objective The aim of this study was to examine the number of hot flush symptom-free days in symptomatic postmenopausal women treated with bazedoxifene/conjugated estrogens (BZA/CE).

Methods In this 12-week, randomized, double-blind, placebo-controlled, phase-3 study, 322 postmenopausal women aged 40–65 years with an intact uterus who had ≥ seven moderate-to-severe daily hot flushes (or ≥ 50 per week) were randomized to BZA 20 mg/CE 0.45 or 0.625 mg or placebo. Subjects recorded the incidence and severity of hot flushes on daily diary cards. In this secondary analysis, the number of days per week without hot flushes from baseline to week 12 was determined. The percentage of women who experienced no hot flushes at week 12 was also evaluated.

Results From baseline to week 12, the number of days per week without moderate-to-severe hot flushes or without any hot flushes steadily increased for women treated with BZA 20 mg/CE 0.45 or 0.625 mg versus placebo. In addition, the rate of increase in days per week without any hot flushes was significantly greater with either BZA/CE dose than with placebo (p < 0.0001). Compared with placebo, the percentage of women who experienced no moderate-to-severe hot flushes or no severe hot flushes at week 12 was greater with BZA 20 mg/CE 0.45 mg (p < 0.01 and p < 0.05, respectively) and BZA 20 mg/CE 0.625 mg (p < 0.001 for both).

Conclusions BZA/CE increased the number of hot flush symptom-free days and the proportion of women without hot flushes over 12 weeks of therapy.

Key words::

• TISSUE SELECTIVE ESTROGEN COMPLEX
• SELECTIVE ESTROGEN RECEPTOR MODULATORS
• HOT FLUSHES
• VASOMOTOR
• BAZEDOXIFENE/CONJUGATED ESTROGENS
• SYMPTOM-FREE DAYS

ACKNOWLEDGEMENTS

Medical writing assistance for this manuscript was provided by Katie Gersh, PhD, of MedErgy and was funded by Pfizer Inc.

Conflict of interest H. Yu and S. Mirkin are full-time employees of Pfizer Inc, Collegeville, PA, USA. J. Racketa and A. A. Chines are former employees of Pfizer Inc.

Source of funding This study was sponsored by Wyeth Research, which was acquired by Pfizer Inc in October 2009.