Kidney Week

Abstract: FR-OR108

Impact of Semaglutide on Infections and COVID-19: Data from the FLOW Trial

Session Information

• Late-Breaking Science Orals - 1
  October 25, 2024 | Location: Room 6C, Convention Center
  Abstract Time: 04:50 PM - 05:00 PM

Category: CKD (Non-Dialysis)

• 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Rayner, Brian, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa

Brian Rayner, MBChB, PhD

• Mahaffey, Kenneth W., Stanford Center for Clinical Research, Department of Medicine, Stanford School of Medicine, Palo Alto, California, United States

Kenneth W. Mahaffey, MD

• Mann, Johannes F., KfH Kidney Centre, München, Germany

Johannes F. Mann, MD

• Pratley, Richard E., Translational Research Institute, AdventHealth Research Institute, Orlando, Florida, United States

Richard E. Pratley, MD

• Tuttle, Katherine R., University of Washington School of Medicine, Seattle, Washington, United States

Katherine R. Tuttle, MD, FASN

• Belmar, Nicolas, Novo Nordisk A/S, Søborg, Denmark

Nicolas Belmar, MD, MSc

• Bosch-Traberg, Heidrun, Novo Nordisk A/S, Søborg, Denmark

Heidrun Bosch-Traberg, MD, DrMed

• Jeppesen, Ole K., Novo Nordisk A/S, Søborg, Denmark

Ole K. Jeppesen, MSc

• Tran, Minh Chau, Novo Nordisk A/S, Søborg, Denmark

Minh Chau Tran, MSc

• Chernin, Gil, Kaplan Medical Center, Rehovot, Israel

Gil Chernin, MD

• Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark

Peter Rossing, MD, DrMed

Background

In the FLOW trial, once-weekly subcutaneous semaglutide 1.0 mg reduced the risk of major kidney and cardiovascular (CV) events in people with type 2 diabetes (T2D) and chronic kidney disease (CKD). This analysis assessed the impact of semaglutide on the incidence of infection adverse events (AEs) and COVID-19 AEs in people with T2D and CKD.

Methods

The main outcome of this analysis was time from randomization to the primary FLOW study outcome (composite of onset of kidney failure, sustained reduction in eGFR, kidney death, or CV death, regardless of COVID-19) including non-CV, non-kidney death concurrent with a COVID-19 serious AE (SAE). A pre-defined MedDRA search was applied for COVID-19 events. Other infection SAEs were collected by standard AE reporting.

Results

Participants (N=3533) had a mean (SD) age of 66.6 (9.0) years, and HbA_1c of 7.8% (1.3) at baseline. 73.6% received a COVID-19 vaccine during the trial. Semaglutide reduced the risk of the main outcome compared to placebo (hazard ratio [HR] [95% CI] 0.78 [0.68, 0.89]; p=0.0004). The semaglutide group also had a lower incidence of infection SAEs (17.9% vs 21.3%; p=0.01), and COVID-19 SAEs (6.7% vs 8.8%; p=0.02). Semaglutide also reduced the risk of an additional endpoint comprising the primary composite outcome including all-cause death concurrent with a COVID-19 SAE (HR [95%CI] 0.80 [0.68, 0.94]; p=0.0079). Semaglutide reduced the risk of a COVID-19 AE or SAE, and risk of hospitalization with an infection (Figure).

Conclusion

In the FLOW trial, semaglutide was associated with lower rates of infection SAEs, COVID-19 AEs and COVID-19 SAEs, in people with T2D and CKD.

Funding

• Commercial Support – Novo Nordisk A/S