Background The effects of the sodium-glucose co-transporter-2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD). Methods The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily reduces risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had: (i) an estimated glomerular filtration rate (eGFR) ≥20, <45 mL/min/1.73m2;  or (ii) an eGFR ≥ 45, <90 mL/min/1.73m2 with a urinary albumin: creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined: extra work for collaborating sites is kept to a minimum, and only essential information is collected. Results Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. Mean age at randomization was 63.8 (SD 13.9) years, 2192 (33%) were female, and 3570 (54%) had no prior history of DM. Mean eGFR was 37.5 (14.8) mL/min/1.73m2, including 5185 (78%) with an eGFR < 45 mL/min/1.73m2. Median (Q1-Q3) uACR was 412 (94–1190) mg/g, with a uACR < 300 mg/g in 3194 (48%). The causes of kidney disease included diabetic kidney disease (n = 2057 [31%]), glomerular disease (n = 1669 [25%]), hypertensive/renovascular disease (n = 1445 [22%]), other (n = 808 [12%]), and unknown causes (n = 630 [10%]). Conclusions EMPA-KIDNEY will evaluate the efficacy and safety of empagliflozin in a widely generalizable population of people with CKD at risk of kidney disease progression. Results are anticipated in 2022.

BACKGROUND: Use of warfarin is standard of care for stroke prevention in patients with atrial fibrillation (AF). However, AF patients experience high rates of warfarin discontinuation/interruption, resulting in increased health risks and health care costs. As such, it is important to study the rates and predictors of warfarin discontinuation/interruption in this population.

Warfarin discontinuation is associated with increased risk of ischemic stroke and TIA. Health care providers may need to take a more active role in the management of warfarin discontinuation and clinical outcomes, e.g., by considering newer anticoagulants with favorable risk-benefit profiles. Key limitations of the study include unavailability of important clinical factors and measures in claims data.

BackgroundPeople living with chronic health conditions exhibit higher risk for developing severe complications from influenza according to the Centers for Diseases Control and Prevention. Although racial and ethnic disparities in influenza vaccination have been documented, it has not been comprehensively determined whether similar disparities are present among the adult population with at least one such condition.ObjectiveTo study if racial and ethnic disparities in relation to influenza vaccination are present in adults suffering from at least one chronic condition and if such inequalities differ between age groups.MethodsThe Medical Expenditure Panel Survey (2011–2012) was used to study the adult population (age ≥18) who had at least one chronic health condition. Baseline differences in population traits across racial and ethnic groups were identified using a chi-square test. This was conducted among various age groups. In addition, survey logistic regression was utilized to produce odds ratios of receiving influenza vaccination annually between racial and ethnic groups.ResultsThe total sample consisted of 15,499 adults living with at least one chronic health condition. The numbers of non-Hispanic whites (whites), non-Hispanic blacks (blacks), and Hispanics were 8,658, 3,585, and 3,256, respectively. Whites (59.93%) were found to have a higher likelihood of self-reporting their receipt of the influenza vaccine in comparison to the black (48.54%) and Hispanic (48.65%) groups (P<0.001). When examining persons aged 50–64 years and ≥65 years, it was noted that the black (54.99%, 62.72%) and Hispanic (53.54%, 64.48%) population had lower rates of influenza vaccine coverage than the white population (59.22%, 77.89) (both P<0.0001). No significant differences between whites and the blacks or Hispanics were found among the groups among adults between 18 and 49 inclusive (P>0.05). After controlling for patient characteristics, the difference in influenza vaccine coverage between whites and the minority groups were no longer significant for adults aged 50–64 years. However, the difference were still statistically significant for those aged ≥65 years.ConclusionsIn the United States, there are significant disparities in influenza vaccination by race and ethnicity for adults over 65 years with at least one chronic health condition. Future research is needed to help develop more targeted interventions to address these issues and improve influenza vaccination rates.

Background Non-Hispanic Blacks (Blacks) and Hispanics have a lower likelihood of being eligible for medication therapy management (MTM) services than do non-Hispanic Whites (Whites) based on Medicare MTM eligibility criteria. Objective To determine whether MTM eligibility criteria would perform differently over time, this study examined the trend of MTM disparities from 1996–1997 to 2007–2008. Methods The study populations were Medicare beneficiaries from the Medical Expenditure Panel Survey. Proportions and the odds of MTM eligibility were compared between Whites and ethnic minorities. The trend of disparities was examined by including in logistic regression models interaction terms between dummy variables for the minority groups and 2007–2008. MTM eligibility thresholds for 2008 and 2010–2011 were analyzed. Main and sensitivity analyses were conducted to represent the entire range of the eligibility criteria. Results This study found no statistical significant racial or ethnic disparities associated with the MTM eligibility criteria for 2008 among the Medicare population during 1996–1997. However, racial disparities associated with 2010–2011 MTM eligibility criteria were significant according to multivariate analyses among the Medicare population during 1996–1997. During 2007–2008, both racial and ethnic disparities associated with both 2008 MTM eligibility criteria and 2010–2011 eligibility criteria were generally significant. Disparity patterns did not exhibit a statistically significant change from 1996–1997 to 2007–2008. Conclusion Racial and ethnic disparities in meeting MTM eligibility criteria may not decrease over time unless MTM eligibility criteria are changed.