Ospemifene for the Treatment of Vulvovaginal Atrophy and Dyspareunia in Postmenopausal Women

Abstract

Vulvovaginal atrophy (VVA) and dyspareunia are common problems experienced by postmenopausal women, although few seek treatment. Symptom-based therapies include nonhormonal vaginal lubricants, vaginal moisturizers, low-dose vaginal estrogen, and systemic estrogen. The 2013 United States Food and Drug Administration approval of ospemifene, an estrogen agonist/antagonist for the treatment of moderate-to-severe dyspareunia associated with VVA, increased options available to women. Several studies have evaluated the effects of ospemifene on VVA and dyspareunia and indicate an improvement in subjective findings. Objective findings such as a decrease in pH and recovery of a premenopausal vaginal maturation index have been reported. Beneficial effects have also been demonstrated in bone. Evaluations of breast health support the safety of ospemifene, although data are limited to 1 year. Short-term risks appear to be limited and include the development of hot flushes. Until additional comparative studies of ospemifene and estrogens have been performed, ospemifene should be recommended for women with symptoms of VVA and dyspareunia who are unable to tolerate or unwilling to take local or systemic estrogens. In this review, current evidence for the safety and efficacy of ospemifene in the treatment of moderate-to-severe VVA and dyspareunia are evaluated.

Alternative Medications for Medications in the Use of High‐Risk Medications in the Elderly and Potentially Harmful Drug–Disease Interactions in the Elderly Quality Measures

“…Vaginal estrogen is another alternative that replenishes the affected tissue with a lower or negligible risk of the serious adverse events of their systemic counterparts . Ospemifene, a specific estrogen receptor modifier, is approved for the treatment of dyspareunia and is another potential alternative, although it shares many of the same warnings as estrogens, and long‐term evidence in women aged 65 and older is lacking. The SSRI escitalopram, the SNRI venlafaxine, and gabapentin have all demonstrated efficacy for treating the symptoms of vasomotor instability, most notably hot flashes .…”

Urogenital atrophy: The ‘unknown factors’ challenging current practice

“…8 The exact number of affected women is thus unknown, with speculative estimates ranging from 10–84% of menopausal women. 3,4,24–55 Improving diagnostic accuracy has the potential to improve precision in relation to prevalence rates and to support a more accurate estimate of the burden of the disease.…”