New data from the FLOW trial, presented at the American Society of Nephrology's Kidney Week 2024, highlights the benefits of semaglutide 1.0 mg (Ozempic) in patients with type 2 diabetes and chronic kidney disease (CKD). The trial's findings underscore the importance of comorbidity management in this patient population.
The FLOW trial, which was discontinued early due to overwhelming efficacy demonstrated by semaglutide, involved 3553 patients across 387 sites in 28 countries. Participants were randomized in a 1:1 ratio to receive either semaglutide 1.0 mg or a placebo. The primary outcome assessed was major kidney disease events, defined as dialysis, kidney transplantation, a decline in eGFR to less than 15 ml/min/1.73m2, a 50% or greater reduction in eGFR from baseline, or death from kidney-related or cardiovascular causes.
Significant Reduction in Kidney Disease Events
Overall, the trial demonstrated that semaglutide was associated with a 24% relative risk reduction in major kidney disease events compared to placebo (Hazard Ratio [HR], 0.76; 95% Confidence Interval [CI], 0.66 to 0.88; P = .0003).
Mortality Benefits
Richard Pratley, MD, medical director at the Advent Health Diabetes Institute and co-chair of the FLOW trial, presented data at Kidney Week 2024 indicating that semaglutide reduced the risk of all-cause mortality (HR, 0.80; 95% CI, 0.67 to 0.95), cardiovascular death (HR, 0.71; 95% CI, 0.56 to 0.89), and death of undetermined cause (HR, 0.62; 95% CI, 0.42 to 0.91).
Causes of Death Analysis
An examination of the causes of death revealed that the most common causes of cardiovascular death in the trial were sudden cardiac death (2.8% in the semaglutide group vs 3.8% in the placebo group) and heart failure (0.3% vs 0.7%, respectively). Semaglutide did not appear to have a significant effect on non-cardiovascular/non-kidney or kidney-related deaths.
