Ozempic (semaglutide injection) cut risk of death in diabetes patients with chronic kidney disease reported in NEJM.-Novo Nordisk.
Novo Nordisk’s Ozempic cut the risk of death in a trial of patients with type 2 diabetes and chronic kidney disease, suggesting it may offer some added benefits over other classes of drugs approved to treat this population. Specifically, the diabetes drug cut the risk of cardiovascular-related deaths by 29% and all-cause deaths by 20%.
Given the study parameters, this implies that over three years, 39 people would need to be treated to prevent one death from any cause, according to new results presented Friday at a meeting of the European Renal Association and published in the New England Journal of Medicine.
Ozempic also lowered the risk of major heart complications — including cardiovascular-related death, heart attack, or stroke — by 18%, driven primarily by the reduced rate of heart-linked death.
The full results of this trial, called FLOW, affirm the primary result reported earlier this year that Ozempic reduced the risk of major kidney events — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24%. Ozempic, part of the class of GLP-1 drugs, is already widely used to treat type 2 diabetes. But these results may further boost usage of the medication in patients who also have kidney disease, a population estimated to make up 40% of diabetes patients.
Doctors pointed to the reduced risk of death as a potential point of differentiation for Ozempic compared with other treatments, though they cautioned that death was not the primary outcome studied in this trial. A different drug class that’s approved for this population, SGLT2 inhibitors, has shown mixed results on mortality benefit.
“I think that’s one of the things that makes this particular study stand out is that it’s just uniformly positive, but it’s [also] these major outcomes,” said Richard Pratley, co-chair of the FLOW trial and senior investigator and diabetes program lead at Advent Health Translational Research Institute.
Novo plans to apply this year for FDA approval to expand Ozempic’s usage to treat chronic kidney disease. The company has been studying its GLP-1 drugs in a range of disease areas. Ozempic’s sister obesity drug, Wegovy, was recently approved for cardiovascular risk reduction, and Novo has also been testing Wegovy in heart failure, MASH, and Alzheimer’s.
See- "Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes"- Authors: Vlado Perkovic, M.B., B.S., Ph.D., Katherine R. Tuttle, M.D., Peter Rossing, M.D., D.M.Sc. , Kenneth W. Mahaffey, M.D., Johannes F.E. Mann, M.D., George Bakris, M.D. h, Florian M.M. Baeres, M.D., Thomas Idorn, M.D., Ph.D., Heidrun Bosch-Traberg, M.D., Nanna Leonora Lausvig, M.Sc., and Richard Pratley, M.D., for the FLOW Trial Committees and Investigators. Published May 24, 2024 DOI: 10.1056/NEJMoa2403347.
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