Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene.
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.


METHODS
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.
Pfizer Ltd., Dorking Road, Tadworth, Kent KT20 7NS, UK. Electronic address: Lucy.Abraham@pfizer.com.
Lucy
L
Abraham
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.
JoAnn V
JV
Pinkerton
Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: Michael.Messig@pfizer.com.
Michael
M
Messig
Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: Kelly.A.Ryan@pfizer.com.
Kelly A
KA
Ryan
Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: Barry.Komm@pfizer.com.
Barry S
BS
Komm
Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: Mirkin.Sebastian@gmail.com.
Sebastian
S
Mirkin
D004311:Double-Blind Method; D004967:Estrogens / Q000627:therapeutic use; D004966:Estrogens, Conjugated (USP) / Q000627:therapeutic use*; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy*; D019584:Hot Flashes / Q000517:prevention & control*; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008593:Menopause; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control; D011446:Prospective Studies; D011788:Quality of Life; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use; D012735:Sexual Dysfunction, Physiological / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D014621:Vagina / Q000473:pathology; D014623:Vaginal Diseases / Q000188:drug therapy; D014844:Vulva / Q000473:pathology; D014845:Vulvar Diseases / Q000188:drug therapy
D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene
CE/BZA; Menopause-specific quality of life; Osteoporosis; TSECs; Vasomotor symptoms; Vulvar/vaginal atrophy