<p>Ospemifene in the Management of Vulvar and Vaginal Atrophy: Focus on the Assessment of Patient Acceptability and Ease of Use</p>

Abstract

Endocrinological changes that occur with menopause lead to a chronic and progressive condition named vulvar and vaginal atrophy (VVA). This disease is characterized by symptoms such as dryness, dyspareunia, itching, burning, and dysuria. According to recent epidemiological studies, VVA has a high prevalence and can also occur in younger women prior to the menopause, negatively affecting quality of life, sexual function, intimacy and relationship with the partner. Accordingly, therapy should be effective, initiated early and continued for as long as possible. Up to recent years, available therapeutic options have included over-the-counter lubricants and moisturizers, vaginal oestrogens and systemic hormones. These products are not indicated for all women. Hormones are mostly contraindicated in women with a history of hormone-sensitive cancer and are frequently not accepted even by women without contraindications. Local therapies are frequently considered uncomfortable, difficult to apply, and messy. Indeed, these treatments have a high spontaneous discontinuation rate, mostly due to dissatisfaction, safety concern, side effects and difficulty in vaginal placement. Recently, ospemifene, a new non-hormonal systemic remedy, was approved by FDA (Food and Drug Administration) and EMA (European Medicines Agency) for the treatment of the two most bothersome symptoms of VVA: dryness and dyspareunia. Because ospemifene is a selective estrogen receptor modulator (SERM), it can be administered also in women with a history of breast cancer, and this makes it more acceptable by any woman. In addition, its route of administration minimizes those bothersome side effects intrinsic to the vaginal route of administration. Available data indicate that women using ospemifene have higher adherence to treatment, higher persistence and lower discontinuation rate. Satisfaction is higher than with other local therapies and overall health care cost is lower.

Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis

“…Vulvovaginal atrophy therapies may also differ in terms of compliance and adherence, which are likely to be better for ospemifene compared with vaginal treatments, as ospemifene is a daily oral therapy. 60,61 The analysis of endometrial outcomes included endometrial thickness and histology. The endometrial thickness slightly increased with all treatments including ospemifene, without being clinically significant.…”

Management of Hypertension with Female Sexual Dysfunction

“…It does not increase the risk of thrombosis as other SERM drugs do, such as tamoxifen. Its side effects include hot flashes in 7.5% of patients and mild muscle spasms in 3% of patients [ 41 ].…”

“…In November 2015, the FDA approved intravaginal prasterone (dehydroepiandrosterone (DHEA)) to treat women experiencing moderate dyspareunia due to menopause [ 42 ]. Oral conjugated estrogen increases the risk of thrombosis, while thrombosis has not been associated with vaginal estrogen [ 41 ]. The most common side effect of intravaginal prasterone is application site discharge [ 43 ].…”

Menopoz Semptomlarına Özgü Güncel Kanıt Temelli Uygulamalar

“…Mevcut veriler, Ospemifen kullanan kadınların tedaviye daha fazla bağlı kaldıklarını, memnuniyet oranlarının yüksek ve ilacı bırakma oranlarının daha düşük olduğunu göstermiştir. 30…”