Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes

发布时间：2025-08-25 22:42

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Randomized Controlled Trial

. 2024 Jul 11;391(2):109-121.

doi: 10.1056/NEJMoa2403347. Epub 2024 May 24.

Collaborators, Affiliations

PMID: 38785209 DOI: 10.1056/NEJMoa2403347

Randomized Controlled Trial

Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes

Vlado Perkovic et al. N Engl J Med. 2024.

Abstract

Background: Patients with type 2 diabetes and chronic kidney disease are at high risk for kidney failure, cardiovascular events, and death. Whether treatment with semaglutide would mitigate these risks is unknown.

Methods: We randomly assigned patients with type 2 diabetes and chronic kidney disease (defined by an estimated glomerular filtration rate [eGFR] of 50 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams] of >300 and <5000 or an eGFR of 25 to <50 ml per minute per 1.73 m2 and a urinary albumin-to-creatinine ratio of >100 and <5000) to receive subcutaneous semaglutide at a dose of 1.0 mg weekly or placebo. The primary outcome was major kidney disease events, a composite of the onset of kidney failure (dialysis, transplantation, or an eGFR of <15 ml per minute per 1.73 m2), at least a 50% reduction in the eGFR from baseline, or death from kidney-related or cardiovascular causes. Prespecified confirmatory secondary outcomes were tested hierarchically.

Results: Among the 3533 participants who underwent randomization (1767 in the semaglutide group and 1766 in the placebo group), median follow-up was 3.4 years, after early trial cessation was recommended at a prespecified interim analysis. The risk of a primary-outcome event was 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.88; P = 0.0003). Results were similar for a composite of the kidney-specific components of the primary outcome (hazard ratio, 0.79; 95% CI, 0.66 to 0.94) and for death from cardiovascular causes (hazard ratio, 0.71; 95% CI, 0.56 to 0.89). The results for all confirmatory secondary outcomes favored semaglutide: the mean annual eGFR slope was less steep (indicating a slower decrease) by 1.16 ml per minute per 1.73 m2 in the semaglutide group (P<0.001), the risk of major cardiovascular events 18% lower (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.029), and the risk of death from any cause 20% lower (hazard ratio, 0.80; 95% CI, 0.67 to 0.95, P = 0.01). Serious adverse events were reported in a lower percentage of participants in the semaglutide group than in the placebo group (49.6% vs. 53.8%).

Conclusions: Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease. (Funded by Novo Nordisk; FLOW ClinicalTrials.gov number, NCT03819153.).

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Comment in

In T2DM with CKD, semaglutide reduced major kidney disease events at 3 y.

Collister D, Pannu N. Collister D, et al. Ann Intern Med. 2024 Sep;177(9):JC98. doi: 10.7326/ANNALS-24-01579-JC. Epub 2024 Sep 3. Ann Intern Med. 2024. PMID: 39222509

Semaglutide for Chronic Kidney Disease in Type 2 Diabetes.

da Hora Passos R, Narciso RC, da Silva AA. da Hora Passos R, et al. N Engl J Med. 2024 Nov 7;391(18):1757. doi: 10.1056/NEJMc2410532. N Engl J Med. 2024. PMID: 39504528 No abstract available.

Semaglutide for Chronic Kidney Disease in Type 2 Diabetes. Reply.

Perkovic V, Tuttle KR, Pratley R. Perkovic V, et al. N Engl J Med. 2024 Nov 7;391(18):1757. doi: 10.1056/NEJMc2410532. N Engl J Med. 2024. PMID: 39504529 No abstract available.

Semaglutid schützt Herz und Nieren bei Typ-2-Diabetes.

Schwinger RHG. Schwinger RHG. MMW Fortschr Med. 2024 Nov;166(19):28-29. doi: 10.1007/s15006-024-4438-6. MMW Fortschr Med. 2024. PMID: 39511083 Review. German. No abstract available.

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