Changes in 24-hour blood pressure profile after 12 weeks of dapagliflozin treatment in patients with diabetic kidney disease: an Italian multicenter prospective study.

IF 3.9 2区医学 Q1 UROLOGY & NEPHROLOGY

Clinical Kidney Journal Pub Date : 2024-10-17 eCollection Date: 2024-11-01 DOI:10.1093/ckj/sfae316

Silvio Borrelli, Carlo Garofalo, Gianpaolo Reboldi, Annapaola Coppola, Paolo Chiodini, Mariadelina Simeoni, Alessio Mazzieri, Luca Della Volpe, Maurizio Gallieni, Carola Zummo, Santina Cottone, Maura Ravera, Filippo Aucella, Francesco Aucella, Giovanni Stallone, Valeria Gismondi, Federico Alberici, Marco Gregori, Giuseppe Castellano, Simone Vettoretti, Mario Cozzolino, Chiara Ruotolo, Roberto Minutolo, Luca De Nicola

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引用次数: 0

Abstract

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) lower ambulatory blood pressure (ABP) in patients with type 2 diabetes mellitus; whether the same holds true in diabetic kidney disease (DKD) is unknown. This information is critical to the knowledge of mechanisms of nephroprotection and safety of this therapy.

Methods: This multicenter prospective study evaluates the changes in ABP after 12 weeks of dapagliflozin 10 mg/day in a cohort of patients with type 2 DKD and glomerular filtration rate (GFR) >25 mL/min/1.73 m². Primary endpoint was the change of nighttime systolic blood pressure (SBP). Changes of daytime SBP, prevalence of normal dipping (day/night SBP ratio <0.9) and changes in ABP patterns, that is, sustained uncontrolled hypertension (SUCH), white coat uncontrolled hypertension (WUCH), masked uncontrolled hypertension (MUCH) and controlled hypertension (CH) were secondary endpoints.

Results: Eighty-three of 96 patients completed the study [age 68.7 ± 8.9 years, 73.5% males, GFR 49 ± 17 mL/min/1.73 m², median albuminuria: 0.18 (interquartile range 0.10-0.38) g/24 h]. After 12 weeks of dapagliflozin, nighttime SBP declined by -3.0 mmHg (95% confidence interval -5.2/-0.8 mmHg; P = .010) with an improvement of nighttime SBP goal (<110 mmHg) from 18.0% to 27.0% (P < .001). Similarly, the prevalence of normal dipping increased (from 31.3% to 50.6%, P = .005). A decrease in daytime (-2.4 mmHg; P = .046) and office (-7.9 mmHg; P = .009) SBP was also found. The decline of ambulatory and office SBP was associated with increased prevalence of CH (from 6.0% to 18.0%) and significant improvement of SUCH, WUCH and MUCH (P = .009). Albuminuria decreased (P < .001), whereas eGFR did not change (P = .297). Urinary tract infection (4.2%) and acute kidney injury (3.6%) were the main causes of drop-out. Only one patient showed a drop of nighttime SBP below 90 mmHg.

Conclusions: Dapagliflozin is associated with improvement in circadian blood pressure rhythm with no major safety signal related to excessive blood pressure decrease.

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糖尿病肾病患者接受达帕格列净治疗 12 周后 24 小时血压曲线的变化：一项意大利多中心前瞻性研究。

背景：钠-葡萄糖共转运体2抑制剂（SGLT2i）可降低2型糖尿病患者的卧床血压（ABP），但糖尿病肾病（DKD）患者的卧床血压是否也会降低尚不清楚。这些信息对于了解肾脏保护机制和这种疗法的安全性至关重要：这项多中心前瞻性研究对肾小球滤过率 (GFR) >25 mL/min/1.73 m2 的 2 型糖尿病肾病患者队列进行了评估。主要终点是夜间收缩压（SBP）的变化。日间收缩压的变化、正常降压的发生率（昼夜收缩压比值结果：96 名患者中有 83 人完成了研究[年龄 68.7 ± 8.9 岁，73.5% 为男性，GFR 49 ± 17 mL/min/1.73 m2，白蛋白尿中位数：0.18（四分位间范围 0.10-0.38) g/24 h]。服用达帕格列净 12 周后，夜间 SBP 下降了-3.0 mmHg（95% 置信区间-5.2/-0.8 mmHg；P = 0.010），夜间 SBP 目标有所改善（P = 0.005）。日间（-2.4 mmHg；P = .046）和办公室（-7.9 mmHg；P = .009）SBP 也有所下降。非卧床和办公室 SBP 的下降与 CH 患病率的增加（从 6.0% 升至 18.0%）以及 SUCH、WUCH 和 MUCH 的显著改善有关（P = .009）。白蛋白尿减少（P = .297）。尿路感染（4.2%）和急性肾损伤（3.6%）是退出治疗的主要原因。只有一名患者的夜间 SBP 降至 90 mmHg 以下：达帕格列净可改善昼夜血压节律，且无与血压过度下降相关的重大安全信号。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Kidney Journal Medicine-Transplantation

CiteScore

6.70

自引率

10.90%

发文量

242

审稿时长

8 weeks

期刊介绍： About the Journal Clinical Kidney Journal: Clinical and Translational Nephrology (ckj), an official journal of the ERA-EDTA (European Renal Association-European Dialysis and Transplant Association), is a fully open access, online only journal publishing bimonthly. The journal is an essential educational and training resource integrating clinical, translational and educational research into clinical practice. ckj aims to contribute to a translational research culture among nephrologists and kidney pathologists that helps close the gap between basic researchers and practicing clinicians and promote sorely needed innovation in the Nephrology field. All research articles in this journal have undergone peer review.