Sleep Disturbance Among Adults With Overactive Bladder: A Cross-sectional Survey.

OBJECTIVE: To examine differences in sleep disturbance, nocturia, and depression among adults with overactive bladder (OAB) by treatment type. METHODS: A cross-sectional survey of adults with OAB assessed sleep disturbance, nocturia, and depression using patient-reported outcome measures, including the Patient Reported Outcomes Measurement Information System (PROMIS)-29 Profile v2.1 (Sleep Disturbance and Depression domains), Lower Urinary Tract Dysfunction Research Network Symptom Index-10, and PROMIS Sleep Disturbance Short Form 8B. Treatment groups included antimuscarinics, ß-3 adrenergic agonists, and no treatment. Analysis of covariance (ANCOVA) was used to test for differences in study endpoints; Bonferroni-adjusted pairwise tests (P < .05/3) were performed to compare differences in least squares means between groups. RESULTS: One hundred participants were included per treatment group. The overall mean (standard deviation) age across all groups was 47.8 (11.8) years. Symptom scores across all PROMIS domains in all three treatment groups were higher than the US general population. There were no statistically significant differences in outcomes across treatment groups. CONCLUSION: Adults with OAB reported being affected by sleep disturbance and depression, regardless of treatment. The mirabegron group trended toward the lowest symptom impact across all outcomes, however, comparisons were not significant. Future research should examine temporal associations between OAB treatment, sleep disturbance, and outcomes.

Prolonged-Release vs Immediate-Release Tacrolimus Capsules in Black vs White Kidney Transplant Patients: A Post Hoc Analysis of Phase III Data.

BACKGROUND: Black kidney transplant patients experience inferior outcomes compared with other ethnicities. Because scrutiny is required when immunosuppressant drugs are used in such at-risk populations, we report the first large-scale clinical efficacy data assessing prolonged-release tacrolimus (PR-T) in black de novo kidney transplant patients. METHODS AND MATERIALS: We used logistic regression and proportionate hazards to compare a composite outcome measure (biopsy-proven acute rejection, graft loss, mortality, and loss to follow-up) in black and white patients in treatment groups longer than 24 weeks, from 3 large Phase III randomized controlled trials. Secondary endpoints included tacrolimus trough concentration, dose, and estimated glomerular filtration rate. RESULTS: The study included 2162 patients whose treatments belonged to two categories (immediate-release tacrolimus: 77 black patients, 721 white patients; and PR-T: 87 black patients, 1277 white patients). Despite demographic factors generally predictive of worse outcomes, efficacy failure among black patients who received PR-T was non-inferior to that among white patients who received either therapy. Compared with immediate-release tacrolimus, black patients who received PR-T achieved stable tacrolimus concentrations 2.5 times faster (21 vs 56 days, P = .04), and more achieved stable target concentrations (76.7% vs 69.3%). Treatment-emergent adverse events were consistent with those reported separately in pivotal trials. CONCLUSIONS: Overall, black patients who received PR-T achieved non-inferior outcomes compared to white patients, despite higher pretransplant risk among black patients. Moreover, PR-T improved the time to achieve, and the likelihood of reaching, stable therapeutic concentrations among black patients, suggesting that PR-T could improve the consistency of tacrolimus exposure in this patient population.