Results showed that Novo Nordisk’s Ozempic (semaglutide) cut the risk of death by 20% compared to placebo in people with type 2 diabetes and chronic kidney disease (CKD). The detailed findings from the FLOW trial were presented Friday at the European Renal Association (ERA) congress and published in The NEJM.
Study investigator Vlado Perkovic said the findings, which build on those top-lined in March, “offer great promise in reshaping treatment strategies for individuals at high risk of diabetes-related complications, offering a new avenue for kidney and cardiovascular protection.”
Novo Nordisk announced last October that the FLOW study achieved its primary endpoint, with a 1mg dose of Ozempic demonstrating a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death versus placebo. Results released earlier this year demonstrated that the GLP-1 analogue cut the risk of kidney disease-related events by 24% compared to placebo, with both CKD and cardiovascular components of the primary endpoint contributing to the risk reduction.
The latest results showed that as well as the reduction in all-cause mortality, Ozempic cut the risk of major cardiovascular events by 18% over placebo, while the total eGFR slope was 1.16 ml/min/1.73m2/year slower. In addition, for the primary endpoint, findings were similar for a composite of the kidney-specific components of the primary outcome, with a hazard ratio (HR). and for death from cardiovascular causes, with a HR of 0.71.
Perkovic remarked “these benefits signify a profound clinical impact saving kidneys, hearts and lives, for patients with type 2 diabetes and chronic kidney disease.”