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Objectives IgG4-related disease (IgG4-RD) can affect nearly any organ and is often treated with glucocorticoids, which contribute to organ damage and toxicity. Comorbidities and healthcare utilization in IgG4-RD are poorly understood. Methods We conducted a cohort study using claims data from a US managed care organization. Incident IgG4-RD cases were identified using a validated algorithm; general population comparators were matched by age, sex, race/ethnicity and index date. The frequency of 21 expert-defined clinical outcomes associated with IgG4-RD or its treatment and healthcare-associated visits and costs were assessed 12 months before and 36 months after the index date (date of earliest IgG4-RD-related claim). Results There were 524 cases and 5240 comparators. Most cases received glucocorticoids prior to (64.0%) and after (85.1%) the index date. Nearly all outcomes, many being common glucocorticoid toxicities, occurred more frequently in cases vs comparators. During follow-up, the largest differences between cases and comparators were seen for gastroesophageal reflux disease (prevalence difference: +31.2%, P  < 0.001), infections (+17.3%, P  < 0.001), hypertension (+15.5%, P  < 0.01) and diabetes mellitus (+15.0%, P  < 0.001). The difference in malignancy increased during follow-up from +8.8% to +12.5% (P  < 0.001). Some 17.4% of cases used pancreatic enzyme replacement therapy during follow-up. Over follow-up, cases were more often hospitalized (57.3% vs 17.2%, P  < 0.01) and/or had an emergency room visit (72.0% vs 36.7%, P  < 0.01); all costs were greater in cases than comparators. Conclusions Patients with IgG4-RD are disproportionately affected by adverse outcomes, some of which may be preventable or modifiable with vigilant clinician monitoring. Glucocorticoid-sparing treatments may improve these outcomes. [ABSTRACT FROM AUTHOR]

Background: We examined the relationship of midlife cardiovascular health (CVH) with late-life robustness among men and women and the impact of survivorship bias on sex differences in robustness.Methods: Prospective analysis of 15 744 participants aged 45-64 (visit 1 median age: 54 years, 55% female, 27% Black) in 1987-1989 from the population-based Atherosclerosis Risk in Communities Study. CVH was operationalized according to the Life's Simple 7 (LS7) metric of health behaviors (smoking, weight, physical activity, diet, cholesterol, blood pressure, and glucose); each behavior was scored as ideal (2 points), intermediate (1 point), or poor (0 points) and summed. Late-life robust/prefrail/frailty was defined at visit 5 (2011-2013). Multinomial regression estimated relative prevalence ratios (RPRs) of late-life robustness/prefrailty/frailty/death across overall midlife LS7 score and components, for the full visit 1 sample. Separate analyses considered visit 5 survivors-only.Results: For each 1-unit greater midlife LS7 score, participants had a 37% higher relative prevalence of being robust versus frail (overall RPR = 1.37 [95% confidence interval {CI}: 1.30-1.44]; women = 1.45 [1.36-1.54]; men = 1.24 [1.13-1.36]). Among the full visit 1 sample, women had a similar 1-level higher robustness category prevalence (RPR = 1.35 [95% CI: 1.32-1.39]) than men (RPR = 1.31 [95% CI: 1.27-1.35]) for every 1-unit higher midlife LS7 score. Among survivors, men were more likely to be robust than women at lower LS7 levels; differences were attenuated and not statistically different at higher midlife LS7 levels.Conclusions: Midlife CVH is positively associated with robustness in late life among men and women. Accounting for mortality in part explains documented sex differences in robustness across all levels of LS7. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Many patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) experience a delay in treatment or fail to initiate treatment with guideline-recommended angiotensin-converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) after CKD diagnosis. This study aimed to describe treatment patterns and treatment initiation after initial CKD diagnosis among patients with T2D. STUDY DESIGN: Retrospective analysis using data from the Optum Clinformatics Data Mart administrative claims database (January 2014-September 2018). METHODS: Adult patients with T2D entered the cohort if they met the criteria for CKD, defined as 2 laboratory test results 90 to 365 days apart (January 2014-September 2017) indicating CKD. Included were patients with no prior use of ACEis or ARBs or evidence of kidney disease in the 365 days prior to cohort entry (baseline). Patients were followed for a maximum of 365 days and were censored on death, disenrollment, or end of data. Patient demographics, comorbidities, and medication use were assessed at baseline, and treatments were assessed over a 1-year followup period. Multivariate logistic regression was used to identify factors associated with ACEi or ARB initiation. RESULTS: Among 15,400 eligible patients without prior ACEi or ARB treatment, only 17% initiated such therapy within a year after meeting CKD criteria. Patients who were White, resided in the northeastern United States, had more comorbidities, had less advanced albuminuria, or used sodium-glucose cotransporter 2 inhibitors were less likely to initiate treatment. CONCLUSIONS: A large proportion of patients with T2D meeting criteria for CKD do not initiate the recommended therapy within 1 year of CKD diagnosis, highlighting a need for new therapies that can slow the progression of CKD. [ABSTRACT FROM AUTHOR]

Background Chronic kidney disease (CKD), one of the most common complications of type 2 diabetes (T2D), is associated with poor health outcomes and high healthcare expenditures. As the CKD population increases, a better understanding of the prevalence and progression of CKD is critical. However, few contemporary studies have explored the progression of CKD relative to its onset in T2D patients using established markers derived from real-world care settings. Methods This retrospective, population-based cohort study assessed CKD progression among adults with T2D and with newly recognized CKD identified from US administrative claims data between 1 January 2008 and 30 September 2018. Included were patients with T2D and laboratory evidence of CKD as indicated by the established estimated glomerular filtration rate (eGFR) and urine albumin:creatinine ratio (UACR) criteria. Disease progression was described as transitions across the eGFR- and UACR-based stages. Results A total of 65 731 and 23 035 patients with T2D contributed to the analysis of eGFR- and UACR-based CKD stage progression, respectively. CKD worsening was observed in approximately 10–17% of patients over a median follow-up of 2 years. Approximately one-third of patients experienced an increase in eGFR values or a decrease in UACR values during follow-up. Conclusions A relatively high proportion of patients were observed with disease progression over a short period of time, highlighting the need for better identification of patients at risk of rapidly progressive CKD. Future studies are needed to determine the clinical characteristics of these patients to inform earlier diagnostic and therapeutic interventions aimed at slowing disease progression. [ABSTRACT FROM AUTHOR]

Purpose We evaluated the reproducibility of a study characterizing newly‐diagnosed multiple myeloma (MM) patients within an electronic health records (EHR) database using different analytic tools. Methods: We reproduced the findings of a descriptive cohort study using an iterative two‐phase approach. In Phase I, a common protocol and statistical analysis plan (SAP) were implemented by independent investigators using the Aetion Evidence Platform® (AEP), a rapid‐cycle analytics tool, and SAS statistical software as a gold standard for statistical analyses. Using the UK Clinical Practice Research Datalink (CPRD) dataset, the study included patients newly diagnosed with MM within primary care setting and assessed baseline demographics, conditions, drug exposure, and laboratory procedures. Phase II incorporated analysis revisions based on our initial comparison of the Phase I findings. Reproducibility of findings was evaluate by calculating the match rate and absolute difference in prevalence between the SAS and AEP study results. Results: Phase I yielded slightly discrepant results, prompting amendments to SAP to add more clarity to operational decisions. After detailed specification of data and operational choices, exact concordance was achieved for the number of eligible patients (N = 2646), demographics, comorbidities (i.e., osteopenia, osteoporosis, cardiovascular disease [CVD], and hypertension), bone pain, skeletal‐related events, drug exposure, and laboratory investigations in the Phase II analyses. Conclusions: In this reproducibility study, a rapid‐cycle analytics tool and traditional statistical software achieved near‐exact findings after detailed specification of data and operational choices. Transparency and communication of the study design, operational and analytical choices between independent investigators were critical to achieve this reproducibility. [ABSTRACT FROM AUTHOR]

Cases of a rare but serious infection called Fournier's gangrene have been reported with sodium‐glucose co‐transporter‐2 inhibitors (SGLT‐2i). To evaluate the safety signal in a population of patients with type 2 diabetes, we used administrative claims data from Horizon Blue Cross Blue Shield of New Jersey from 2014 through 2017 to estimate incidence rates of Fournier's gangrene or necrotizing fasciitis of the perineum among patients treated with a second‐line antidiabetic drug. We found very low incidence rates of Fournier's gangrene or necrotizing fasciitis. While we found no indication of an increased risk among SGLT‐2i users compared with similar patients treated with other second‐line antidiabetic medications, the small number of events yielded wide confidence intervals. [ABSTRACT FROM AUTHOR]