Sponsored Lunch Symposium

Treating VVA early improves outcome



INTRODUCTION: Vulvar and vaginal atrophy (VVA) is caused by the reduction in circulating oestrogen in postmenopausal women and causes symptoms in approx. 50% of women, most commonly vaginal dryness, dyspareunia and vulvar and vaginal irritation and itching. Unlike vasomotor symptoms, which are often self-limiting, postmenopausal VVA is a progressive disorder, which, if left untreated, generally worsens over time. Many women do not recognise it as being associated with the menopause and the condition often goes underreported. Doctors often underdiagnose and undertreat the condition. This may lead to many women presenting at an advanced stage of disease with severe symptoms. Senshio® (ospemifene) is indicated for moderate to severe symptomatic VVA in post-menopausal women who are not candidates for local vaginal oestrogen therapy. Since Senshio® has been proven to be effective in both severe and moderate VVA, we wanted to see if early treatment leads to higher cure rates AIM: To assess whether early treatment of VVA symptoms leads to greater treatment benefit. METHODS: Two 12-week pivotal trials enrolled women with at least one moderate or severe symptom of vaginal dryness or dyspareunia. In addition, the effect on all VVA symptoms was recorded for all women. Symptom severity was reported by the patient as none, mild, moderate or severe. Improvement was defined as one or more steps in reduction of severity and relief was defined as mild or no symptoms after 12 weeks. RESULTS: The co-primary endpoints included the effect on the Most Bothersome Symptom (MBS) of VVA (dryness or dyspareunia). Improvement in MBS was not substantially different in women with moderate or severe MBS at baseline (74.1% vs. 76.7% respectively). However, relief was substantially higher in the group with moderate MBS compared to those with severe MBS at baseline (74.1% vs. 55.0%). Improvement of all moderate or severe symptoms was also similar (78.3% VS. 82.4%, respectively), But there was nearly a 20% difference in the proportion of symptoms whose severity was none or mild at 12 weeks (76.2% vs. 56.8% respectively). DISCUSSION: The similar improvement seen with Senshio® on MBS or all moderate or severe symptoms at baseline confirm that it is effective, regardless of the severity of the symptoms. But the relief given to patients is greater when treatment of VVA with Senshio® is started early rather than late. Early treatment, may also prevent the late sequelae of VVA.