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Vlado Perkovic, Katherine R. Tuttle, Peter R Rossing, Kenneth W. Mahaffey, Johannes F.E. Mann, George L. Bakris, Florian M.M. Baeres, Thomas Idorn, Heidrun Bosch‐Traberg, Nanna Leonora Lausvig, Richard E. Pratley
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 m 2 of body-surface area and a urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams] of >300 and 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 m 2 ), 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 m 2 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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Perkovic, V., Tuttle, K. R., Rossing, P. R., Mahaffey, K. W., Mann, J. F., Bakris, G. L., Baeres, F. M., Idorn, T., Bosch‐Traberg, H., Lausvig, N. L., & Pratley, R. E. (2024). Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. New England Journal of Medicine, 391(2), 109–121. https://doi.org/10.1056/nejmoa2403347
Perkovic, Vlado, et al. "Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes." New England Journal of Medicine, vol. 391, no. 2, 2024, pp. 109–121, https://doi.org/10.1056/nejmoa2403347.
Perkovic, Vlado, Katherine R. Tuttle, Peter R Rossing, Kenneth W. Mahaffey, Johannes F.E. Mann, George L. Bakris, Florian M.M. Baeres, et al. "Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes." New England Journal of Medicine 391, no. 2 (2024): 109–121. https://doi.org/10.1056/nejmoa2403347.
Perkovic V., Tuttle K. R., Rossing P. R. [и др.] Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes // New England Journal of Medicine. — 2024. — Vol. 391, № 2. — P. 109–121. — URL: https://doi.org/10.1056/nejmoa2403347
@article{perkovic2024effects,
title = {{Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes}},
author = {Vlado Perkovic and Katherine R. Tuttle and Peter R Rossing and Kenneth W. Mahaffey and Johannes F.E. Mann and George L. Bakris and Florian M.M. Baeres and Thomas Idorn and Heidrun Bosch‐Traberg and Nanna Leonora Lausvig and Richard E. Pratley},
journal = {New England Journal of Medicine},
year = {2024},
volume = {391},
number = {2},
pages = {109--121},
doi = {10.1056/nejmoa2403347},
url = {https://doi.org/10.1056/nejmoa2403347}
}TY - JOUR AU - Perkovic, Vlado AU - Tuttle, Katherine R. AU - Rossing, Peter R AU - Mahaffey, Kenneth W. AU - Mann, Johannes F.E. AU - Bakris, George L. AU - Baeres, Florian M.M. AU - Idorn, Thomas AU - Bosch‐Traberg, Heidrun AU - Lausvig, Nanna Leonora AU - Pratley, Richard E. TI - Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes JO - New England Journal of Medicine VL - 391 IS - 2 SP - 109 EP - 121 PY - 2024 DA - 2024/05/24 DO - 10.1056/nejmoa2403347 UR - https://doi.org/10.1056/nejmoa2403347 ER -
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