Menopause-specific quality of life across varying menopausal populations with
conjugated estrogens/bazedoxifene.
Author(s): Abraham L(1), Pinkerton JV(2), Messig M(3), Ryan KA(4), Komm BS(5), Mirkin S(6).
Affiliation(s): Author information:
(1)Pfizer Ltd., Dorking Road, Tadworth, Kent KT20 7NS, UK. Electronic address:
Lucy.Abraham@pfizer.com. (2)Department of Obstetrics and Gynecology, Division of
Midlife Health, University of Virginia Health System, 1215 Lee Street,
Charlottesville, VA 22903, USA. Electronic address: jvp9u@virginia.edu. (3)Pfizer
Inc., 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address:
Michael.Messig@pfizer.com. (4)Pfizer Inc., 500 Arcola Road, Collegeville, PA
19426, USA. Electronic address: Kelly.A.Ryan@pfizer.com. (5)Pfizer Inc., 500
Arcola Road, Collegeville, PA 19426, USA. Electronic address:
Barry.Komm@pfizer.com. (6)Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426,
USA. Electronic address: Mirkin.Sebastian@gmail.com.
Publication date & source: 2014, Maturitas. , 78(3):212-8
OBJECTIVE: Describe the effects of conjugated estrogens/bazedoxifene (CE/BZA), a
new treatment for vasomotor symptoms (VMS) and osteoporosis prevention, on
menopause-specific quality of life (MSQOL) across different patient population
types in phase 3 clinical trials.
DESIGN: MSQOL was prospectively evaluated in 4 randomized, double-blind,
placebo-controlled studies. The populations studied included healthy,
non-hysterectomized postmenopausal women with symptomatic VMS or vulvar-vaginal
atrophy (VVA) and general postmenopausal women (eligible regardless of symptoms).
Menopause-specific Quality of Life (MENQOL) questionnaire total and domain scores
for CE 0.625 mg/BZA 20mg and CE 0.45 mg/BZA 20mg were evaluated and compared with
established thresholds for clinically important differences (CID).
RESULTS: Significant improvements compared with placebo were found with both
CE/BZA doses in MENQOL vasomotor domain (-0.61 to -2.23 over 3-24 months) and
total scores (-0.24 to -0.94) in the general and symptomatic VMS/VVA populations.
Significant improvement compared with placebo in sexual domain (-0.11 to -0.72)
was observed with the higher dosage for all populations, and with the lower
dosage in the VVA (-0.71 at month 3) and general populations (-0.4 at months 12
and 24). Improvements in vasomotor domain exceeded the CID with both doses in
symptomatic VMS populations and with the higher dosage in women with symptomatic
VVA; for total MENQOL, the CID was exceeded with the higher dose in symptomatic
VMS populations.
CONCLUSIONS: CE/BZA significantly improved overall and vasomotor-related MSQOL
across populations of postmenopausal women with varying baseline symptom
statuses. Women with greater menopausal symptoms at baseline were more likely to
experience clinically meaningful changes.
Erratum in
Maturitas. 2014 Dec;79(4):488.
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