Effects of Raloxifene Combined with Low-dose Conjugated Estrogen on the Endometrium in Menopausal Women at High Risk for Breast Cancer

Authors

  • Andrea Lucia Bastos Carneiro Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia
  • Ana Paula Curi Spadella Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia
  • Fabiola Amaral de Souza Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia
  • Karen Borelli Ferreira Alves Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia
  • Joaquim Teodoro de Araujo-Neto Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia
  • Mauro Abi Haidar Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia
  • Rita de Cássia de Maio Dardes Universidade Federal de São Paulo. Escola Paulista de Medicina. Departamento de Ginecologia

DOI:

https://doi.org/10.6061/clinics/2021/e2380

Keywords:

SERMs, Endometrium, Estrogen, Raloxifene

Abstract

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 scoreX1.67 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 X5 mm or if vaginal bleeding occurred. The primary outcome was the occurrence of ETX5 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 ETX5 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.

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Published

2021-11-09

Issue

Section

Original Articles

How to Cite

Effects of Raloxifene Combined with Low-dose Conjugated Estrogen on the Endometrium in Menopausal Women at High Risk for Breast Cancer. (2021). Clinics, 76, e2380. https://doi.org/10.6061/clinics/2021/e2380