| 초록 |
Objectives: Pooled analyses of individual participant data from the SELECT, FLOW, and SOUL trials were conducted to determine the effect of semaglutide on pre-specified major kidney outcomes in participants with or without type 2 diabetes. Methods: Participants were randomized to receive semaglutide (once-weekly subcutaneous 1.0 mg/2.4 mg [FLOW/SELECT] or once-daily oral 14 mg [SOUL]) vs placebo. The main outcome was time to first occurrence of a 5-point chronic kidney disease composite (defined in figure). Results: A total of 30,787 participants were included. Compared with placebo, pooled semaglutide consistently reduced the risk of the main 5-point composite outcome (hazard ratio [HR] 0.84 [95% CI 0.77, 0.91]), a kidney-specific outcome excluding cardiovascular (CV) death (HR 0.80 [95% CI 0.69, 0.92]) (Figure), and kidney failure (estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m2 or initiation of chronic kidney replacement therapy; HR 0.83 [95% CI 0.69, 1.00]). No indication of treatment heterogeneity was observed for any kidney outcomes across baseline eGFR groups (<60 or ≥60 mL/min/1.73 m2; interaction p values >0.1). Serious adverse events were reported in 6130 participants (39.8%) assigned pooled semaglutide and 6581 (42.8%) assigned placebo. Conclusion: Semaglutide reduced the risk of pre-specified major kidney outcomes in a broad population with CV-kidney-metabolic disease, irrespective of baseline eGFR. |