达格列净治疗糖尿病肾病患者12周后24小时血压谱的变化：一项意大利多中心前瞻性研究
Changes in 24-hour blood pressure profile after 12 weeks of dapagliflozin treatment in patients with diabetic kidney disease: an Italian multicenter prospective study.
作者信息
Borrelli Silvio, Garofalo Carlo, Reboldi Gianpaolo, Coppola Annapaola, Chiodini Paolo, Simeoni Mariadelina, Mazzieri Alessio, Della Volpe Luca, Gallieni Maurizio, Zummo Carola, Cottone Santina, Ravera Maura, Aucella Filippo, Aucella Francesco, Stallone Giovanni, Gismondi Valeria, Alberici Federico, Gregori Marco, Castellano Giuseppe, Vettoretti Simone, Cozzolino Mario, Ruotolo Chiara, Minutolo Roberto, De Nicola Luca
机构信息
Unit of Nephrology, Dept of Advanced Medical and Surgery Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of Medicine, University of Perugia, Perugia, Italy.
出版信息
Clin Kidney J. 2024 Oct 17;17(11):sfae316. doi: 10.1093/ckj/sfae316. eCollection 2024 Nov.
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 m. 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 m, 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; = .010) with an improvement of nighttime SBP goal (<110 mmHg) from 18.0% to 27.0% ( < .001). Similarly, the prevalence of normal dipping increased (from 31.3% to 50.6%, = .005). A decrease in daytime (-2.4 mmHg; = .046) and office (-7.9 mmHg; = .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 ( = .009). Albuminuria decreased ( < .001), whereas eGFR did not change ( = .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.
背景
钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）可降低2型糖尿病患者的动态血压（ABP）；在糖尿病肾病（DKD）患者中是否同样如此尚不清楚。这一信息对于了解该疗法的肾脏保护机制和安全性至关重要。
方法
这项多中心前瞻性研究评估了2型DKD且肾小球滤过率（GFR）>25 mL/min/1.73 m²的患者队列中，每日服用10 mg达格列净12周后ABP的变化。主要终点是夜间收缩压（SBP）的变化。日间SBP的变化、正常杓型血压（日间/夜间SBP比值<0.9）的患病率以及ABP模式的变化，即持续性未控制高血压（SUCH）、白大衣未控制高血压（WUCH）、隐匿性未控制高血压（MUCH）和控制良好的高血压（CH）是次要终点。
结果
96例患者中有83例完成了研究[年龄68.7±8.9岁，男性占73.5%，GFR 49±17 mL/min/1.73 m²，尿白蛋白中位数：0.18（四分位间距0.10 - 0.38）g/24小时]。达格列净治疗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目标值（<110 mmHg）从18.0%提高到27.0%（P < 0.001）。同样，正常杓型血压的患病率增加（从31.3%增至50.6%，P = 0.005）。还发现日间（-2.4 mmHg；P = 0.046）和诊室（-7.9 mmHg；P = 0.009）SBP有所下降。动态血压和诊室SBP的下降与CH患病率增加（从6.0%增至18.0%）以及SUCH、WUCH和MUCH的显著改善相关（P = 0.009）。尿白蛋白减少（P < 0.001），而估算肾小球滤过率（eGFR）未改变（P = 0.297）。尿路感染（4.2%）和急性肾损伤（3.6%）是导致退出研究的主要原因。仅1例患者夜间SBP降至90 mmHg以下。
结论
达格列净与昼夜血压节律改善相关，且未发现与血压过度下降相关的重大安全信号。
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