Clinical Trial Considerations in Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: A Scientific Workshop Cosponsored by the National Kidney Foundation and the US Food and Drug Administration

Inker, Lesley A.; Grams, Morgan E.; Guðmundsdóttir, Hrefna; McEwan, Phil; Friedman, Robert; Thompson, Aliza; Weiner, Daniel E.; Willis, Kerry; Heerspink, Hiddo J L; Little, Dustin J.; Jha, Vivekanand; West, Melissa; Levey, Andrew S.; Walsh, Michael; Mottl, Amy K.; Tangri, Navdeep; Madero, Magdalena; Patel, Uptal D.; Gillespie, Barbara S.; Crews, Deidra C.; Levin, Adeera

doi:10.1053/j.ajkd.2022.03.011

Cited by 2 publications

(2 citation statements)

References 41 publications

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“…It is associated with high morbidity/mortality burden and health expenditures [ 61 ]. There has been discussion about optimal selection of clinically relevant endpoints in trials to assess kidney-specific drug efficacy [ 62 , 63 ]. Incident end-stage kidney disease or need for renal replacement therapy is without doubt a very serious clinical condition.…”

Section: Discussionmentioning

confidence: 99%

Absolute treatment effects of novel antidiabetic drugs on a composite renal outcome: meta-analysis of digitalized individual patient data

Brockmeyer,

Parco,

Vargas

et al. 2024

J Nephrol

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Background Absolute treatment benefits—expressed as numbers needed to treat—of the glucose lowering and cardiovascular drugs, glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose transporter 2 (SGLT2) inhibitors on renal outcomes remain uncertain. With the present meta-analysis of digitalized individual patient data, we aimed to display and compare numbers needed to treat of both drugs on a composite renal outcome. Methods From Kaplan–Meier plots of major cardiovascular outcome trials of GLP-1 receptor agonists and SGLT2 inhibitors vs. placebo, we digitalized individual patient time-to-event information on composite renal outcomes with WebPlotDigitizer 4.2; numbers needed to treat from individual cardiovascular outcome trials were estimated using parametric Weibull regression models and compared to original data. Random-effects meta-analysis generated meta-numbers needed to treat with 95% confidence intervals (CI). Results Twelve cardiovascular outcome trials (three for GLP-1 receptor agonists, nine for SGLT2 inhibitors) comprising 90,865 participants were included. Eight trials were conducted in primary type 2 diabetes populations, two in a primary heart failure and two in a primary chronic kidney disease population. Mean estimated glomerular filtration rate at baseline ranged between 37.3 and 85.3 ml/min/1.73 m2. Meta-analyses estimated meta-numbers needed to treat of 85 (95% CI 60; 145) for GLP-1 receptor agonists and 104 (95% CI 81; 147) for SGLT2 inhibitors for the composite renal outcome at the overall median follow-up time of 36 months. Conclusion The present meta-analysis of digitalized individual patient data revealed moderate and similar absolute treatment benefits of GLP-1 receptor agonists and SGLT2 inhibitors compared to placebo for a composite renal outcome. Graphical Abstract

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Section: Discussionmentioning

confidence: 99%

Absolute treatment effects of novel antidiabetic drugs on a composite renal outcome: meta-analysis of digitalized individual patient data

Brockmeyer,

Parco,

Vargas

et al. 2024

J Nephrol

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“…Recently, a workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration explored the role of medications for treating early-stage CKD, highlighting that while long-term benefits may exist, all medications carry cost and a potential for risk. 3,4 Exercise presents an attractive adjunctive or even dominant option for improving outcomes in people with kidney disease, that, unlike medications, may incur minimal cost and risk. Exercise has a beneficial impact on multiple bodily functions, including diabetes and glucose tolerance, cardiovascular function, blood pressure control, sleep, and weight loss.…”

mentioning

confidence: 99%