Richard Pratley, MD: FLOW Mortality Data and Allocation Strategies for Semaglutide

New data from the FLOW trial presented during the American Society of Nephrology’s Kidney Week 2024 is shedding further light on the benefits of semaglutide 1.0 mg (Ozempic) among patients with type 2 diabetes and chronic kidney disease (CKD).

Coming less than 6 months after the trial headlined the 61st European Renal Association Congress, data from Kidney Week detail the most common causes of death from cardiovascular causes within the trial, further underlining the importance of comorbidity management among patients with type 2 diabetes and CKD.¹

Discontinued following prespecified interim analysis concluding semaglutide demonstrated overwhelming efficacy, the FLOW trial recruited 3553 patients from 387 sites in 28 countries and randomized them in a 1:1 ratio to semaglutide 1.0 mg or placebo therapy. The trial’s primary outcome of interest was major kidney disease events, which investigators defined as dialysis, transplantation, an eGFR decline to less than 15 ml/min/1.73m2, a reduction of 50% or greater in eGFR from baseline, or death from kidney-related or cardiovascular causes.^1,2

Overall results of the trial demonstrated use of semaglutide was associated with a 24% relative risk reduction for the trial’s primary outcome of major kidney disease events compared to placebo therapy (Hazard Ratio [HR], 0.76; 95% Confidence Interval [CI], 0.66 to 0.88; P = .0003).²

Data from Kidney Week 2024, which was presented by trial cochair Richard Pratley, MD, medical director at the Advent Health Diabetes Institute, indicate 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).

When examining differences in causes of death, the most common causes of cardiovascular death in the trial were sudden cardiac death (2.8% vs 3.8%) and heart failure (0.3% vs 0.7%), which both occurred more frequently among those receiving placebo therapy. Investigators noted semaglutide had no effect on non-cardiovascular/non-kidney or kidney death.¹

For more on this study and the role of semaglutide in the management of CKD among patients with type 2 diabetes, check out our interview with Pratley from the floor at Kidney Week 2024.

Relevant disclosures for Pratley include Novo Nordisk, Merck, Bayer, Eli Lilly and Company, Rivus Pharmaceuticals, and more.

References:

1. Pratley RE, Mahaffey KW, Mann JF, et al. Effect of Semaglutide on Mortality Outcomes in the FLOW Trial. Presented at American Society of Nephrology Kidney Week 2024. San Diego, CA. October 23-27, 2024.
2. Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024;391(2):109-121. doi:10.1056/NEJMoa2403347