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

Leadership through the Lens of Young Female Professionals: A Hermeneutic Phenomenological Study

This study aims to highlight the lived experiences of young female professionals who currently lead in their fields, as well as the essence of a woman leader in such instances. The researchers used a hermeneutic phenomenological approach to illuminate the key informants\u27 lived experiences as leaders with the anticipation to arrive at a novel perspective of leadership. The research findings align with the concept of purpose-driven leadership. The links between themes like compassion, empowerment, and adaptability are, however, intriguing because these leadership attributes are strongly associated with feminist conceptions of relationality, flexibility, and intuition. The key informants\u27 collective reverence may be viewed as a distinctive leadership experience, indicating that the Filipino backdrop could not be separated from a woman leader\u27s values and standards

Crop Domestication in the Asia Pacific Region: A review

Understanding crop domestication provides a basis for ongoing genetic improvement of crops, especially in the utilization of wild crop relatives as a source of new variation and may guide the domestication of new crops. The Asia Pacific region is home to most of the world’s human population and is a region in which many important crops were domesticated. Here we review the domestication of banana, citrus, coconut, macadamia, mango, millet, mungbean, rice, sugarcane and taro in the Asia Pacific region. These examples illustrate the importance of this region in the development of agriculture. The challenges of conservation of the genetic resources for these crops are exacerbated by the large human population and rapid economic development in the region. Advances in genetic technologies provide an opportunity for accelerated genetic improvement of these crops and the domestication of new crops

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial

Background: Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate. Methods: This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination. Results: 1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains. Conclusions: In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults. Clinical trial registry number: NCT01481454

Avaliação do consumo alimentar de crianças pertencentes a uma creche filantrópica na Ilha de Paquetá, Rio de Janeiro, Brasil Food intake assessment of children attending a philanthropic daycare center in the Ilha de Paquetá, Rio de Janeiro, Brazil

OBJETIVOS: comparar o consumo alimentar de pré-escolares, pertencentes a uma creche filantrópica, em dois períodos (no ato da matrícula e após seis meses), com base na proposta da Pirâmide Alimentar Infantil Norte-Americana e através do Índice de Alimentação Saudável (IAS). MÉTODOS: relativamente à avaliação dietética, foi utilizada a história alimentar da criança com o responsável, no ato da matrícula; após seis meses de frequência da criança, utilizou-se o método de pesagem de alimentos (na creche) e registro alimentar (na residência). Posteriormente, compararam-se as médias das porções consumidas nos dois períodos, de cada grupo alimentar, utilizando o teste "t" Student, a fim de se verificar a diferença estatística entre os grupos. Considerou-se o nível de significância de 5%. Igualmente, avaliou-se o IAS, nos dois períodos. RESULTADOS: observou-se uma diferença significativa (p<0,05) entre a média das porções de frutas e vegetais, com base na Pirâmide Alimentar Americana, e um escore satisfatório do Índice de Alimentação Saudável, após seis meses de frequência da criança na creche. CONCLUSÕES: a freqüência à creche parece trazer benefícios para a nutrição de crianças pertencentes à estratos socioeconômicos menos favorecidos.<br>OBJECTIVES: to compare the food intake of children in a philanthropic daycare center in two periods (at enrollment and following six months attendance) based on the North American Food Guide Pyramid through the Healthy Eating Index (HEI). METHODS: the children eating habits were informed by the parents or custodians at enrollment and following six months of children's attendance, the food weighing technique was performed (at the daycare center) and food checking (at home) as well. Following, averages of the portions eaten in the two periods were compared in each of the food intake groups through the "t" Student test to determine the statistical significance between the groups, with the significance rate established at 5%. HEI for the two periods was equally assessed. RESULTS: a significant difference (p<0,05) was determined in the average of fruit and vegetable portions consumed, based on the North American Food Pyramid, and a satisfactory scoring of the Healthy Eating Index following six months of the children's attendance of the day care center. CONCLUSIONS: child attendance of daycare centers may result in nutrition benefits for low income families' children