Treating VVA improves symptom severity and patient-reported outcomes: 6-month PEONY results

Objective: The real-world PatiEnt satisfactiON studY (PEONY) involves postmenopausal women already treated or starting local estrogen therapy (LET) or ospemifene. The aim of the present analysis was to assess treatment satisfaction and persistence, effectiveness and patient-reported outcomes (PROs) in sexual function and quality of life after 6 months of therapy with LET or ospemifene to treat vulvovaginal atrophy (VVA). Methods: PEONY is an ongoing prospective, observational study conducted in 17 gynecology centers. Participants complete questionnaires at baseline (T0) and after 3 months (T3) and 6 months (T6). The main outcome measures were treatment satisfaction, severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale–Revised (FSDS-R) and SF-12 Health Survey. Results: Overall, 385 women were included, of whom 145 started (87.6%) or continued (12.4%) ospemifene and 240 started (66.7%) or continued (33.3%) LET at T0. The likelihood of moderate/severe VVA symptoms decreased by 70–90% and the mean treatment satisfaction score increased overall from 7.3 (95% confidence interval [CI]: 7.0; 7.5) at T3 to 7.7 (95% CI: 7.4; 7.9) at T6 (p = 0.003). DIVA and FSDS-R scores significantly improved in both groups. Conclusions: PEONY underlines the importance of proactively treating VVA with LET or ospemifene to alleviate the burden associated with the disease.