Effects of Raloxifene Combined with Low-dose Conjugated Estrogen on the Endometrium in Menopausal Women at High Risk for Breast Cancer.
Autor: | Carneiro ALB; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR., Spadella APC; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR., Souza FA; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR., Alves KBF; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR., Araujo-Neto JT; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR., Haidar MA; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR., Dardes RCM; Departamento de Ginecologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), Sao Paulo, SP, BR. |
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Jazyk: | angličtina |
Zdroj: | Clinics (Sao Paulo, Brazil) [Clinics (Sao Paulo)] 2021 Jan 20; Vol. 76, pp. e2380. Date of Electronic Publication: 2021 Jan 20 (Print Publication: 2021). |
DOI: | 10.6061/clinics/2021/e2380 |
Abstrakt: | Objectives: To compare the effects of low-dose conjugated estrogen (CE), raloxifene, and the combination thereof on the endometrium of postmenopausal women. Methods: Postmenopausal women between 45 and 60 years of age, with Gail score≥1.67 and no endometrial disorders, were randomly assigned to receive low-dose CE (0.3 mg), raloxifene (60 mg), or combined therapy for 1 year. Transvaginal ultrasound was performed at baseline and every 3 months; the Kupperman Index was assessed at baseline and every 6 months. Endometrial biopsies were performed if endometrial thickness (ET) was ≥5 mm or if vaginal bleeding occurred. The primary outcome was the occurrence of ET≥5 mm over the one-year period. Results: Seventy-three women were randomly assigned and analyzed on an intent-to-treat basis. Eight, three, and four women in the CE, raloxifene, and combination groups, respectively, exhibited ET≥5 mm. No genital bleeding was reported in the combination group. Endometrial biopsy revealed atrophy or polyps in all groups, with one patient in the CE group exhibiting a proliferative endometrium without atypia. At 6 months, there was a progressive increase in mean ET in the CE group, but not in the other two groups, with statistically significant differences at 6, 9, and 12 months. Mean scores for vasomotor symptoms and Kupperman Index favored the CE and combination groups over raloxifene. Conclusion: Combined raloxifene and low-dose CE decreased the severity of menopausal symptoms to a similar extent as CE alone and had similar effects as raloxifene alone on the endometrium. |
Databáze: | MEDLINE |
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