Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) trials.
J Womens Health (Larchmt)
; 23(1): 18-28, 2014 Jan.
Article
en En
| MEDLINE
| ID: mdl-24206058
ABSTRACT
BACKGROUND:
Bazedoxifene/conjugated estrogens (BZA/CE), a novel tissue-selective estrogen complex (TSEC), has been evaluated in the Selective estrogens, Menopause And Response to Therapy (SMART) trials. Secondary outcomes from these trials were evaluated to determine whether the effects of BZA/CE are influenced by years since menopause (YSM).METHODS:
SMART-1 and SMART-2 were randomized, double-blind, placebo (PBO)-controlled phase 3 trials in nonhysterectomized postmenopausal women. Outcomes were evaluated for women <5 or ≥5 YSM in SMART-1 (BZA 20 mg/CE 0.45 mg, n=433; BZA 20 mg/CE 0.625 mg, n=414; PBO, n=427) and SMART-2 (BZA 20 mg/CE 0.45 mg, n=127; BZA 20 mg/CE 0.625 mg, n=128; PBO, n=63). Hot-flush frequency and severity, health-related quality of life (HRQoL), sleep, treatment satisfaction, cumulative amenorrhea, and breast pain were assessed for each study individually, using defined statistical analysis protocols.RESULTS:
For <5 and ≥5 YSM subgroups, BZA 20 mg/CE 0.45 and 0.625 mg showed significant decreases in hot-flush frequency and severity at 3 months compared with PBO (p<0.05 for both). Both BZA/CE doses showed significant improvements compared with PBO in HRQoL scores, sleep parameters, and satisfaction with treatment at 3 months irrespective of YSM (p≤0.05 vs. PBO for all). Similar to PBO, BZA/CE showed high proportions of cumulative amenorrhea (SMART-1) and low incidences of breast pain (SMART-1 and SMART-2) for women <5 and ≥5 YSM.CONCLUSIONS:
The positive effects of BZA/CE on secondary outcomes were consistent among women <5 or ≥5 YSM.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Posmenopausia
/
Estrógenos Conjugados (USP)
/
Moduladores Selectivos de los Receptores de Estrógeno
/
Estrógenos
/
Indoles
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Aspecto:
Patient_preference
Límite:
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
J Womens Health (Larchmt)
Asunto de la revista:
GINECOLOGIA
/
SAUDE DA MULHER
Año:
2014
Tipo del documento:
Article