Incorporating bazedoxifene/conjugated estrogens into the current paradigm of menopausal therapy

Figures & data

Table 1 Study designs for Phase III clinical trials of BZA/CE

	SMART-1^Citation24^–^Citation27	SMART-2^Citation28	SMART-3^Citation29
Duration	2 years	12 weeks	12 weeks
Design	Randomized, double-blind, placebo-controlled, Phase III study
Treatments	BZA 10, 20, or 40 mg/CE 0.45 or 0.625 mg RLX 60 mg Placebo	BZA 20 mg/CE 0.45 or 0.625 mg Placebo	BZA 20 mg/CE 0.45 or 0.625 mg BZA 20 mg Placebo
Enrolled	Healthy, postmenopausal women with an intact uterus
	Aged 40–75 years	Aged 40–65 years ≥7 moderate-to-severe hot flushes per day (or ≥50 per week)	Aged 40–65 years ≥1 moderate-to-severe symptom of VV A
Primary endpoints	Incidence of endometrial hyperplasia	Frequency/severity of hot flushes	Four coprimary measures of VV A (proportion of vaginal superficial cells, proportion of parabasal cells, vaginal pH, most bothersome symptom)
Secondary endpoints	BMD, BTM, frequency/severity of hot flushes, measures of VV A, sleep, QoL	Sleep, QoL	Sexual function, satisfaction with treatment, QoL

Abbreviations: BZA, bazedoxifene; CE, conjugated estrogens; SMART, Selective estrogens, Menopause, And Response to Therapy; RLX, raloxifene; VV A, vulvar vaginal atrophy; BMD, bone mineral density; BTM, bone turnover markers; QoL, quality of life.

Figure 1 The mean daily number (A) and severity (B) of moderate-to-severe hot flushes over 12 weeks in the SMART-2 trial.

Copyright © 2009, Wolters Kluwer Health. Reprinted with permission from Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause. 2009;16(6):1116–1124.

Abbreviations: SMART, Selective estrogens, Menopause, And Response to Therapy; BZA, bazedoxifene; CE, conjugated estrogens.

Figure 2 Adjusted mean percent change in BMD from baseline over 2 years in the SMART-1 trial.

Copyright © 2009, Elsevier. Reprinted with permission from Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril. 2009;92:1045–1052.

Notes: Lumbar spine BMD was evaluated for women >5 YSM (A), or between 1 and 5 YSM (B); total hip BMD was evaluated for women >5 YSM (C), or between 1 and 5 YSM (D).
Abbreviations: BMD, bone mineral density; SMART, Selective estrogens, Menopause And Response to Therapy; YSM, years since menopause; BZA, bazedoxifene; CE, conjugated estrogens; RLX, raloxifene.

LoboRAPinkertonJVGassMLEvaluation of bazedoxifene/ conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profileFertil Steril20099231025103819635615

 PubMed Web of Science ®Google Scholar

PickarJHYehI-TBachmannGSperoffLEndometrial effects of a tissue selective estrogen complex containing bazedoxifene/ conjugated estrogens as a menopausal therapyFertil Steril20099231018102419635613

 PubMed Web of Science ®Google Scholar

PinkertonJVUtianWHConstantineGDOlivierSPickarJHRelief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trialMenopause20091661116112419546826

 PubMed Web of Science ®Google Scholar

KaganRWilliamsRSPanKMirkinSPickarJHA randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal womenMenopause201017228128919779382

 PubMed Web of Science ®Google Scholar