The FLOW trial of semaglutide versus placebo for kidney outcomes was stopped early due to evidence of kidney protection. Top line results showed the glucagon-like peptide-1 (GLP-1) receptor agonist slowed progression of kidney disease in people with type 2 diabetes and reduced both kidney outcomes and cardiovascular mortality.

“There was a signal that GLP-1 receptor agonists might have kidney benefits in addition to cardiovascular benefits in cardiovascular outcomes trials,” said Richard E. Pratley, MD, Samuel E. Crockett Chair in Diabetes Research, Medical Director of the AdventHealth Diabetes Institute, Senior Investigator and Diabetes Program Lead, AdventHealth Translational Research Institute, and Adjunct Professor of Medicine, Johns Hopkins University School of Medicine. “We are going to be talking about the kidney endpoints of the FLOW trial in some detail and the cardiovascular endpoints as well.”

The First Dedicated Kidney Outcome Trial with a GLP-1 Receptor Agonist Once-Weekly Semaglutide and the FLOW Trial Results will take place on Monday, June 24, from 1:30 p.m. – 3:00 p.m. ET in Room W415B, the Valencia Ballroom, of the Orange County Convention Center.  The session will be livestreamed on the virtual meeting platform for registered meeting participants. It also will be available on-demand following the 84^th Scientific Sessions.

“Diabetes remains the leading cause of chronic kidney disease in most countries,” said Vlado Perkovic, MBBS, PhD, FRACP, FASN, FAHMS, Provost and Health and Scientia Professor, University of New South Wales, Sydney, Australia. “Many of these people end up with kidney failure requiring dialysis or transplant, which has a dramatic, terrible impact on not just their quality of life but their whole family and community. The cost is extraordinary, and, in many countries, dialysis is not available to many citizens. People are effectively sentenced to death if they get kidney failure.”

An estimated 850 million people worldwide have chronic kidney disease.

“Renin-angiotensin system (RAS) inhibition has been the mainstay of renal protective therapy for a quarter century,” Dr. Perkovic noted, followed more recently by sodium-glucose cotransporter-2 (SGLT2) inhibitors and mineralocorticoid receptor agonists (MRAs). “These agents are making a difference in kidney and cardiovascular outcomes but have not resolved the problem.

“Half of people on these drugs are going to progress even if they are receiving the best treatment,” Dr. Perkovic continued. “Hence the interest in GLP-1 receptor agonists.”

Dr. Perkovic will focus on FLOW kidney outcomes, while Kenneth W. Mahaffey, MD, PhD, Professor of Cardiovascular Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, will detail the cardiovascular outcomes.

“Cardiovascular benefits of GLP-1 receptor agonists have been well-documented in people with diabetes,” Dr. Perkovic said. “The headline data from FLOW, a significant reduction in the primary outcome, is just the start of what we need to know. This is one of the highest cardiovascular risk populations that exists, so the breakdown of the primary and secondary outcomes are going to be of huge interest.”

Dr. Pratley will detail FLOW design and baseline characteristics. Katherine R. Tuttle, MD, FASN, FACP, FNKF, Executive Director for Research at Providence Health Care, Regional Principal Investigator of the Institute of Translational Health Sciences, and Professor of Medicine, University of Washington, will provide a recap of current treatment strategies and unmedical needs.

Johannes F.E. Mann, MD, Professor of Medicine, Friedrich Alexander University of Erlangen-Nürnberg and Head of KfH Kidney Centre, Munich, Germany, will discuss the safety outcomes.

“This is a high-risk population with high rates of cardiovascular events, high rates of progression to chronic kidney disease, episodes of heart failure, and more,” Dr. Pratley said. “We potentially have a fourth pillar for preventing progression of chronic kidney disease with significant cardiovascular benefits. This addition to the treatment algorithm will make meaningful impact on patient outcomes, decreasing morbidity and mortality and probably costs.”