安全性和有效性Bexagliflozin的2型糖尿病患者和舞台CKD 3 a / b。

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张Allegretti, W,周W,瑟伯TK, Rigby SP, Bowman-Stroud C, Trescoli C, Serusclat P,弗里曼MW, Halvorsen YC

安全性和有效性Bexagliflozin的2型糖尿病患者和舞台CKD 3 a / b。

肾脏J说。2019年9月,74 (3):328 - 337。doi: 10.1053 / j.ajkd.2019.03.417。2019年5月14日Epub。

PubMed ID

31101403 (在PubMed

]

文摘

理由和目的:高血糖加重慢性肾脏疾病(CKD)的发展,但大多数降糖疗法没有解决的障碍与慢性肾病有关。钠/葡萄糖转运蛋白2 (SGLT2抑制剂)糖尿病和慢性肾病患者提供潜在的好处,但它们的有效性可能与降低肾功能下降。我们的目的是评估bexagliflozin的安全性和有效性,小说SGLT2抑制剂,在2型糖尿病患者和慢性肾病。研究设计:三期、双盲、安慰剂对照、多中心、跨国,随机试验。设置和参与者:54网站在4个国家。CKD患者3或3 b阶段,2型糖尿病,血红蛋白A (1 c)水平的7.0%到10.5%,估计肾小球滤过率(eGFR) 30至59 ml / min / 1.73米(2)以口服降糖药物为8周。干预措施:Bexagliflozin, 20毫克,每日与安慰剂为24周。结果:主要结果是血红蛋白变化百分比(1 c)从基线到24周。次要终点包括体重的变化,收缩期血压、蛋白尿、血红蛋白A (1 c)水平分层的CKD的阶段。结果:312例患者在54个网站进行了分析。 Bexagliflozin lowered hemoglobin A(1c) levels by 0.37% (95% CI, 0.20%-0.54%); P<0.001 compared to placebo. Patients with CKD stages 3a (eGFR, 45-<60mL/min/1.73m(2)) and 3b (eGFR, 30-<45mL/min/1.73m(2)) experienced reductions in hemoglobin A(1c) levels of 0.31% (P=0.007) and 0.43% (P=0.002), respectively. Bexagliflozin decreased body weight (1.61kg; P<0.001), systolic blood pressure (3.8mm Hg; P=0.02), fasting plasma glucose level (0.76mmol/L; P=0.003), and albuminuria (geometric mean ratio reduction of 20.1%; P=0.03). Urinary tract infection and genital mycotic infections were more common in the bexagliflozin group; otherwise, frequencies of adverse events were comparable between groups. LIMITATIONS: Not designed to evaluate the impact of treatment on long-term kidney disease and cardiovascular outcomes. CONCLUSIONS: Bexagliflozin reduces hemoglobin A(1c) levels in patients with diabetes and stage 3a/3b CKD and appears to be well tolerated. Additional observed benefits included reductions in body weight, systolic blood pressure, and albuminuria. FUNDING: Trial was sponsored by Theracos Sub, LLC.

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药物

Bexagliflozin