Ospemifene efficacy and safety data in women with vulvovaginal atrophy

Abstract

Vulvovaginal atrophy (VVA) is a frequent, underreported and underdiagnosed condition. Ospemifene is a third-generation Selective Estrogen Receptor Modulator (SERM) that has been shown to be effective in women with VVA and dyspareunia, vaginal dryness and vulvar vestibular symptoms. Some of the possible side effects included by FDA and EMA are hot flushes, headache, muscle spasms, vaginal bleeding and vaginal discharge. Ospemifene does not increase the incidence of endometrial cancer or hyperplasia. While the efficacy is comparable with that of estrogenic treatments, ospemifene is not only well tolerated and safe but also reduces bone turnover in postmenopausal women, and available data indicate no safety concerns for breast tissue.

摘要

外阴阴道萎缩 (VVA) 是一种常见的、报告不足和诊断不足的疾病。奥培米芬是第三代选择性雌激素受体调节剂 (SERM), 已被证明对有患有VVA和性交困难、阴道干燥和外阴前庭症状的女性有效。FDA和EMA包括的一些可能的副作用是潮热, 头痛, 肌肉痉挛, 阴道出血和阴道分泌物。奥培米芬不会增加子宫内膜癌或子宫内膜增生的发生率。虽然其疗效与雌激素治疗相当, 但奥培米芬不仅具有良好的耐受性和安全性, 而且还能降低绝经后妇女的骨转换, 并且现有数据显示对乳腺组织没有安全担忧。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Ospemifene
• vulvovaginal atrophy
• dyspareunia
• female sexual dysfunction
• SERMs
• breast cancer

Disclosure statement

Lino Del Pup is a consultant to Shionogi Ltd. Rafael Sánchez-Borrego reports research funding from Bayer and personal fees from Shionogi Ltd, Lacer, Mylan, and SEID Lab, outside the submitted work. There are no other conflicts of interest.

Contributors

Both authors contributed equally to this paper.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Writing and editorial support was provided by Emili González-Pérez, PhD and Nerea Gallastegui, PhD from TFS Develop with financial support provided by Shionogi. Sponsored by Shionogi.