Objective: To determine prevalence and health-related quality of life (HRQOL) of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women in Europe, the US, and Japan, and among subgroups of women not taking hormone therapy (HT).Methods: Screening surveys were sent to a random sample of women aged 40 to 65 years; full questionnaires followed to those who completed them and met inclusion criteria. Women with successfully treated VMS, breast cancer, or on HT for medical conditions were excluded. The Menopause-Specific QOL (MENQOL) and Work Productivity and Activity Impairment (WPAI) questionnaires were included in the questionnaire.Results: Of 25,161 women completing the screening survey, 11,771 were postmenopausal and 3,460 met inclusion criteria and completed the full questionnaire. Prevalence of moderate-to-severe VMS was 40%, 34%, and 16% in Europe, the US, and Japan, respectively. A large proportion were HT averse, albeit eligible (Europe 56%, US 54%, Japan 79%). In total, 12%, 9%, and 8% in Europe, the US, and Japan, respectively, were HT-contraindicated. A high proportion were HT-cautious (Europe 70%, US 69%, Japan 52%). Most common menopausal symptoms reported in the MENQOL were feeling tired or worn out (Europe/US 74%, Japan 75%), aching in muscles and joints (Europe 69%, US 68%, Japan 61%), difficulty sleeping (Europe 69%, US 66%, Japan 60%), and hot flashes (Europe 67%, US 68%, Japan 62%). Overall, the most bothersome symptom was weight gain. As measured by the WPAI, hot flashes and night sweats had a greater impact on daily activities than on working activities.Conclusions: A high proportion of women experienced moderate-to-severe VMS, with associated symptoms impacting QOL.

IntroductionEnzalutamide and abiraterone acetate (plus prednisone) are new hormonal treatments for metastatic castration-resistant prostate cancer (mCRPC). This study compared treatment duration, healthcare resource utilization (HRU), and treatment costs for chemotherapy-naïve mCRPC patients treated with enzalutamide or abiraterone acetate in the USA.MethodsChemotherapy-naïve mCRPC patients initiating treatment with enzalutamide or abiraterone acetate were identified from administrative claims. Continuous enrollment ≥ 6 months before and ≥ 3 months after the index date (initiation date of enzalutamide or abiraterone acetate) was required. Treatment duration, all-cause and prostate cancer-related HRU, and costs were estimated during the post-index period. Multivariable analyses compared HRU and costs between cohorts, adjusting for baseline characteristics.ResultsOverall, 920 chemotherapy-naïve patients initiated enzalutamide and 2310 initiated abiraterone acetate (median follow-up, 10.7 and 13.5 months, respectively). More enzalutamide-treated patients had corticosteroid-sensitive comorbidities at baseline. Treatment duration was longer with enzalutamide versus abiraterone acetate (median, 10.7 vs. 8.8 months; P = 0.008). Enzalutamide was associated with fewer all-cause inpatient admissions [adjusted incidence rate ratio (95% confidence interval) 0.87 (0.76, 0.99)], days of hospitalization [0.84 (0.70, 1.02)], and outpatient visits [0.94 (0.90, 0.98)], and fewer prostate cancer-related outpatient visits [0.92 (0.87, 0.96)] compared with abiraterone acetate. Enzalutamide was also associated with lower prostate cancer-related inpatient and emergency department costs [adjusted differences, $122 (P = 0.024) and $28 (P = 0.009), respectively].ConclusionChemotherapy-naïve mCRPC patients treated with enzalutamide versus abiraterone acetate had longer treatment duration and incurred lower HRU and prostate cancer-related inpatient and emergency department costs.FundingAstellas Pharma Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0774-1) contains supplementary material, which is available to authorized users.

Purpose: Age-related macular degeneration (AMD) is a leading cause of blindness, particularly in higherincome countries. Although dry AMD accounts for 85% to 90% of AMD cases, a comprehensive understanding of the global dry AMD burden is needed.Methods: A targeted literature review was conducted in PubMed, MEDLINE, Embase, and the Cochrane Database of Systematic Reviews (1995Reviews ( -2019 to identify data on the epidemiology, management, and humanistic and economic burden of dry AMD in adults. A landscape analysis of patientreported outcome (PRO) instruments in AMD was also conducted via searches in PubMed (1995PubMed ( -2019, ClinicalTrials.gov, PROQOLID, PROLABELS, and health technology assessment reports (2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018).Findings: Thirty-seven of 4205 identified publications were included in the review. Dry AMD prevalence was 0.44% globally, varied across ethnic groups, and increased with age. Patients with dry AMD had higher risks of all-cause mortality (hazard ratio [HR] = 1.46; 95% CI, 0.99-2.16) and tobacco-related (HR = 2.86; 95% CI, 1.15-7.09) or cancer deaths (HR = 3.37; 95% CI, 1.56-7.29; P = 0.002) than those without dry AMD. Smoking, increasing age or cholesterol levels, and obesity are key risk factors for developing dry AMD. No treatment guidelines were identified for dry AMD specifically; management focuses on risk factor reduction and use of dietary supplements. In the United States and Italy, direct medical costs and health care resource utilization were lower in patients with dry versus wet AMD. Patients with dry AMD, particularly advanced disease, experienced significant visual function impairment. Dry AMD symptoms included reduced central vision, decreased ability to see at night, increased visual blurriness, distortion of straight lines and text, and faded color vision. Most PRO instruments used in AMD evaluations covered few, if any, of the identified symptoms reported by patients with dry AMD. Although the Quality of Life and Vision Function Questionnaire, 25-item National Eye Institute Vision Function Questionnaire, Low Vision Quality of Life, Impact of Vision Impairment-Very Low Vision, and Functional Reading Independence Index had strong content validity and psychometric properties in patients with dry AMD, they retained limited coverage of salient concepts.Implications: Despite dry AMD accounting for most AMD cases, there are substantial gaps in the published literature, particularly the humanistic and economic burden of disease and the lack of differentiation among dry, wet, or unspecified dry AMD. The significant burden of illness alludes to a high unmet need for tolerable and effective treatment options, as well as PRO instruments with more coverage of dry AMD symptoms and salient concepts. ( Clin Ther.

212 Background: Prostate cancer (PC) is the most common malignancy among US men and the 2nd leading cause of cancer-related death. African Americans (AAs) have higher mortality from mCRPC than Whites (W). Despite this disparity, a small prior study suggested AAs may have better PSA response to abiraterone acetate (ABAC) than Ws, though radiographic progression did not differ. We evaluated overall survival (OS) in AA vs W chemotherapy-naïve (CN) mCRPC patients (Ps) treated with ABAC or enzalutamide (ENZ). Methods: This was a retrospective study that used the Veterans Health Administration (VHA) database. Male PC Ps (≥18 years) who had surgical or medical castration were identified from Apr 1, 2013 to Mar 31, 2018. The index date was the first prescription claim date for ABAC or ENZ following castration. Ps had no chemotherapy for 12 months pre-index date and had continuous VA health plan enrollment for ≥12 months pre- and post-index date. Ps were followed until death or disenrollment. Unadjusted and Kaplan-Meier survival analyses adjusted for demographic and clinical characteristics were used to calculate survival time, and multivariate Cox proportional hazards models assessed the relationship between race and OS. Results: This study included 2,123 W and 787 AA mCRPC Ps with mean ages of 74 and 71 years, respectively. The median follow‐up time was 570 days and 561 days for AA and W, respectively. AA were more prone to comorbid hypertension (77.1% vs 67.1%; p<.0001), type II diabetes (38.1% vs 29.3%; p<.0001), and liver damage or abnormality (8.8% vs 5.2%; p=0.0003) than W . From the unadjusted analysis, the median Kaplan-Meier estimated OS was 910 days for AAs and 784 days for Ws; AAs had better OS than Ws (HR=0.887; 95%CI [0.790-0.996]). From the adjusted analysis, the median Kaplan-Meier estimated OS was 918 days for AAs and 781 days for Ws; AAs still had better OS (HR=0.826; 95%CI [0.732-0.933]). Conclusions: This large retrospective study provides the first evidence that AA CN mCRPC Ps may have better OS with ABAC or ENZ than W Ps. Trials are needed to validate this finding and explore the mechanisms of racial disparities in outcomes with new hormonal therapies.

Objective Evaluation of the comparative effectiveness of enzalutamide and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) is limited to meta-analyses of randomized trials that exclude patients with significant comorbidities. We evaluated overall survival (OS) in patients with chemotherapy-naive mCRPC treated with enzalutamide or abiraterone acetate (abiraterone) in a real-world single payer setting. Methods A retrospective analysis (4/1/2014–3/31/2018) of the Veterans Health Administration (VHA) database was conducted. Patients with mCRPC had ≥1 pharmacy claim for enzalutamide or abiraterone (first claim date = index date) following disease progression on surgical/medical castration, without chemotherapy <12 months prior to index date. Patients had continuous VHA enrollment for ≥12 months pre-index date and were followed until death, disenrollment, or end of study. Kaplan–Meier analysis and multivariable Cox proportional hazards regression models examined the OS treatment effect. Results Patients with chemotherapy-naive mCRPC (N = 3174; enzalutamide, n = 1229; abiraterone, n = 1945) had mean ages of 74 and 73 years, respectively. Median follow-up was 18.27 and 19.07 months with enzalutamide and abiraterone, respectively. Enzalutamide-treated patients had longer median treatment duration than abiraterone-treated patients (9.93 vs 8.47 months, respectively, p = 0.0008). After baseline comorbidity adjustment, enzalutamide-treated patients had a 16% reduced risk of death (hazard ratio [HR] = 0.84; 95% CI, 0.76–0.94; p = 0.0012). For patients who remained on first line-therapy only, enzalutamide-treated patients had improved OS versus abiraterone-treated patients (HR = 0.71; 95% CI, 0.62–0.82). Enzalutamide-treated patients who crossed over to abiraterone had a comparable risk of death versus abiraterone-treated patients who crossed over to enzalutamide (HR = 0.91; 95% CI, 0.74–1.13). These results were confirmed by sensitivity analysis, which considered prognostic variables. Conclusions Retrospective analysis of the VHA database indicated that chemotherapy-naive patients with mCRPC initiating therapy with enzalutamide had improved survival versus abiraterone.