To estimate the incidence and recurrence of breast cancer (BC) in patients with vulvovaginal atrophy (VVA) treated with ospemifene and matched untreated VVA patients using real-world data. Study design: Retrospective matched cohort study.Main Outcome Measures: VVA patients were identified from the 2011-2018 US MarketScan® insurance claims database. For incidence, ospemifene-treated VVA patients without evidence of BC prior to index treatment were matched to two untreated VVA controls similarly without history of BC on age, index VVA year, geographic region, Charlson Comorbidity categories, and follow-up time. BC after the index treatment was identified by BC diagnosis codes, mastectomy, chemotherapy, or radiation procedure. Incidence rate, rate ratio (RR) and their 95 % confidence intervals (CI) were calculated. The process was repeated to estimate BC recurrence in patients with a history of BC in 1:1, 1:2 and 1:3 matches. Results: 1728 ospemifene users and 3456 untreated patients met the inclusion and matching criteria for assessing incidence. The average number of days for which ospemifene was supplied was 314 (standard deviation [SD] = 340). Average follow-up time from index treatment was 937 days (SD = 392) for treated patients and 915 days (SD = 396) for controls. BC incidence rates per 1000 person-years was 2.03 (95 % CI: 1.06−3.91) for treated patients and 3.53 (95 % CI: 2.49−4.99) for controls (RR = 0.58, 95 % CI: 0.28−1.21). No difference in recurrence was observed between ospemifene-treated and matched untreated patients. Ten (32.3 %) treated vs. 25 (40.3 %) controls in the 1:2 matched analysis had a recurrence. Conclusion: No differences were observed in the BC incidence and recurrence rates in ospemifene users compared with matched controls.
Prevalence of glucose intolerance and other noncommunicable diseases has been examined in subjects aged 35 years and over in semirural and urban communities in the Fergana Valley in the eastern part of Uzbekistan, Central Asia. Diabetes and impaired glucose tolerance (IGT) were diagnosed according to the recommendations of the latest WHO Study Group on diabetes. Crude prevalence of diabetes was 9% and 5%, respectively, in semirural men and women, 13% and 9% in urban men and women. Crude prevalence of impaired glucose tolerance (IGT) was 6% and 9%, respectively, in semirural men and women, 9% and 8% in urban men and women. After adjustment for non-response, prevalence of diabetes was 5% and 4%, respectively, in semirural men and women and 8% in both urban men and women. Adjusted prevalence of IGT was 4% and 8%, respectively, in semirural men and women, 5% and 6% in urban men and women. The majority of subjects with a prior diagnosis of diabetes were being treated with oral hypoglycaemic agents. Almost one-half of subjects in both communities had body mass index of 25 kg m(-2) or greater. Central obesity (waist-hip ratio 0.95 or greater for men, 0.85 or greater for women) was observed in over one-quarter of subjects in both communities. Clinical hypertension was not frequent by international standards (9% in semirural subjects and 13% in urban subjects) but a number of subjects who were clinically normotensive claimed to be taking antihypertensive medication. It is concluded that glucose intolerance and central obesity are common in this region of Uzbekistan, about which there was previously little information.
Objective: To estimate the impact of vulvovaginal atrophy (VVA) on sexual function in a clinical population of postmenopausal women. Methods: Women 45 to 75 years old and more than 12 months after the last menstruation, who attended menopausal/gynecological centers in Italy and Spain, were included. Women with at least one VVA symptom completed the following questionnaires: Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale revised (FSDS-R). A physical gynecological examination was performed to confirm the VVA diagnosis. Data were analyzed by chi-square and Student's t tests. Results: In all, 2,160 evaluable women were included in the study. VVA was confirmed in 90% of the included participants. The negative impact on sexual function was significantly higher in women with than in women without confirmed VVA, as evaluated with the sexual function component (DIVA-C) of the DIVA questionnaire (P = 0.013). Statistically significant differences (P < 0.0005) were also detected in the scores of overall FSDS-R, the overall FSFI, and of all the FSFI subdomains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Conclusion: For postmenopausal women with at least one VVA symptom, the presence of physician-confirmed VVA is associated with significant impaired sexual function, as shown by unadjusted analyses. Given the impact on quality of life and the prevalence of VVA, further research to improve and reduce VVA is warranted.
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