Effects of empagliflozin in patients with chronic kidney disease from Japan: exploratory analyses from EMPA–KIDNEY

Background: EMPA–KIDNEY assessed the effects of empagliflozin 10 mg once daily vs. placebo in 6609 patients with chronic kidney disease (CKD) at risk of progression, including 612 participants from Japan. Methods: Eligibility required an estimated glomerular filtration rate (eGFR) of ≥ 20  Results: Japanese participants had higher levels of albuminuria and eGFR than those from non-Japan regions. During a median of 2.0 year follow-up, a primary outcome occurred in 432 patients (13.1%) in the empagliflozin group and in 558 patients (16.9%) in the placebo group (hazard ratio [HR], 0.72, 95% confidence interval [95%CI] 0.64–0.82; P  Conclusions: Empagliflozin safely reduced the risk of “kidney disease progression or cardiovascular death” in patients with CKD, with consistent effects in participants from Japan

Impact of primary kidney disease on the effects of empagliflozin in patients with chronic kidney disease: secondary analyses of the EMPA-KIDNEY trial

Background: The EMPA KIDNEY trial showed that empagliflozin reduced the risk of the primary composite outcome of kidney disease progression or cardiovascular death in patients with chronic kidney disease mainly through slowing progression. We aimed to assess how effects of empagliflozin might differ by primary kidney disease across its broad population. Methods: EMPA-KIDNEY, a randomised, controlled, phase 3 trial, was conducted at 241 centres in eight countries (Canada, China, Germany, Italy, Japan, Malaysia, the UK, and the USA). Patients were eligible if their estimated glomerular filtration rate (eGFR) was 20 to less than 45 mL/min per 1·73 m2, or 45 to less than 90 mL/min per 1·73 m2 with a urinary albumin-to-creatinine ratio (uACR) of 200 mg/g or higher at screening. They were randomly assigned (1:1) to 10 mg oral empagliflozin once daily or matching placebo. Effects on kidney disease progression (defined as a sustained ≥40% eGFR decline from randomisation, end-stage kidney disease, a sustained eGFR below 10 mL/min per 1·73 m2, or death from kidney failure) were assessed using prespecified Cox models, and eGFR slope analyses used shared parameter models. Subgroup comparisons were performed by including relevant interaction terms in models. EMPA-KIDNEY is registered with ClinicalTrials.gov, NCT03594110. Findings: Between May 15, 2019, and April 16, 2021, 6609 participants were randomly assigned and followed up for a median of 2·0 years (IQR 1·5–2·4). Prespecified subgroupings by primary kidney disease included 2057 (31·1%) participants with diabetic kidney disease, 1669 (25·3%) with glomerular disease, 1445 (21·9%) with hypertensive or renovascular disease, and 1438 (21·8%) with other or unknown causes. Kidney disease progression occurred in 384 (11·6%) of 3304 patients in the empagliflozin group and 504 (15·2%) of 3305 patients in the placebo group (hazard ratio 0·71 [95% CI 0·62–0·81]), with no evidence that the relative effect size varied significantly by primary kidney disease (pheterogeneity=0·62). The between-group difference in chronic eGFR slopes (ie, from 2 months to final follow-up) was 1·37 mL/min per 1·73 m2 per year (95% CI 1·16–1·59), representing a 50% (42–58) reduction in the rate of chronic eGFR decline. This relative effect of empagliflozin on chronic eGFR slope was similar in analyses by different primary kidney diseases, including in explorations by type of glomerular disease and diabetes (p values for heterogeneity all >0·1). Interpretation: In a broad range of patients with chronic kidney disease at risk of progression, including a wide range of non-diabetic causes of chronic kidney disease, empagliflozin reduced risk of kidney disease progression. Relative effect sizes were broadly similar irrespective of the cause of primary kidney disease, suggesting that SGLT2 inhibitors should be part of a standard of care to minimise risk of kidney failure in chronic kidney disease. Funding: Boehringer Ingelheim, Eli Lilly, and UK Medical Research Council

Flexible (Wieder-)Verwendung multimedialer und online verfügbarer Selbstlernmodule in der Wirtschaftsinformatik: Designprinzipien und Lessons Learned

Die Wiederverwendbarkeit von digitalen Lehrinhalten war eine zentrale Frage in dem E-Learning-Projekt „Foundations of Information Systems (FOIS)“, einem Verbundprojekt von fünf Schweizer Universitäten. Während der Projektlaufzeit wurden zwölf multimediale und online verfügbare Selbstlernmodule produziert, die ein breites Spektrum an Wirtschaftsinformatikthemen abdecken und die primär in einführenden Lehrveranstaltungen der Wirtschaftsinformatik gemäß dem Blended-Learning-Ansatz genutzt werden. In dem Artikel beschreiben wir, wie die für die Wiederverwendung von E-Learning-Inhalten und -materialien wesentlichen Aspekte Flexibilität, Kontextfreiheit, inhaltliche und didaktische Vereinheitlichung sowie Blended-Learning-Einsatz in dem Projekt umgesetzt worden sind. Im zweiten Teil gehen wir auf die Erfahrungen ein, die wir und unsere Studierenden mit den FOIS-Module in der Lehre an der Universität Zürich gesammelt haben, und stellen Evaluationsergebnisse aus drei Lehrveranstaltungen und unsere Lessons Learned vor