Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study.

Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study.
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DOI:
10.1136/bmj.k4365
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发表时间:
2018-11-14
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
Pasternak B
Pasternak B
中科院分区:
其他
文献类型:
--
作者:
Ueda P;Svanström H;Melbye M;Eliasson B;Svensson AM;Franzén S;Gudbjörnsdottir S;Hveem K;Jonasson C;Pasternak B

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评估钠葡萄糖协同转运蛋白2(SGLT 2)抑制剂的使用与7起当前关注的严重不良事件之间的相关性。基于登记册的队列研究。2013年7月至2016年12月,瑞典和丹麦。一个倾向评分匹配队列,包括17213例SGLT 2抑制剂新使用者(达格列净,61%;恩格列净,38%;卡格列净,1%)和17213例活性对照药物胰高血糖素样肽1(GLP 1)受体激动剂新使用者。根据医院记录,主要结局为下肢截肢、骨折、糖尿病酮症酸中毒、急性肾损伤、严重尿路感染、静脉血栓栓塞和急性胰腺炎。使用考克斯比例风险模型估计风险比和95%置信区间。与GLP 1受体激动剂相比,使用SGLT 2抑制剂与下肢截肢风险增加相关(发生率2.7 v1.1事件/1000人年,风险比2.32,95%置信区间1.37 - 3.91)和糖尿病酮症酸中毒(1.3 v 0.6,2.14,1.01至4.52),但不伴有骨折(15.4 v 13.9,1.11,0.93 - 1.33),急性肾损伤(2.3 v 3.2,0.69,0.45至1.05),严重尿路感染(5.4 v 6.0,0.89,0.67至1.19)、静脉血栓栓塞(4.2 v 4.1,0.99,0.71至1.38)或急性胰腺炎(1.3 v 1.2,1.16,0.64至2.12)。在这项对两个国家的全国登记研究的分析中,与GLP 1受体激动剂相比,SGLT 2抑制剂的使用与下肢截肢和糖尿病酮症酸中毒的风险增加相关,但与当前关注的其他严重不良事件无关。
To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverse events of current concern. Register based cohort study. Sweden and Denmark from July 2013 to December 2016. A propensity score matched cohort of 17 213 new users of SGLT2 inhibitors (dapagliflozin, 61%; empagliflozin, 38%; canagliflozin, 1%) and 17 213 new users of the active comparator, glucagon-like peptide 1 (GLP1) receptor agonists. The primary outcomes were lower limb amputation, bone fracture, diabetic ketoacidosis, acute kidney injury, serious urinary tract infection, venous thromboembolism, and acute pancreatitis, as identified from hospital records. Hazard ratios and 95% confidence intervals were estimated by using Cox proportional hazards models. Use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation (incidence rate 2.7 v 1.1 events per 1000 person years, hazard ratio 2.32, 95% confidence interval 1.37 to 3.91) and diabetic ketoacidosis (1.3 v 0.6, 2.14, 1.01 to 4.52) but not with bone fracture (15.4 v 13.9, 1.11, 0.93 to 1.33), acute kidney injury (2.3 v 3.2, 0.69, 0.45 to 1.05), serious urinary tract infection (5.4 v 6.0, 0.89, 0.67 to 1.19), venous thromboembolism (4.2 v 4.1, 0.99, 0.71 to 1.38) or acute pancreatitis (1.3 v 1.2, 1.16, 0.64 to 2.12). In this analysis of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverse events of current concern.
DOI: 10.2147/tcrm.s86641
发表时间: 2015
影响因子: 2.8
作者:
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DOI: 10.1056/nejmoa1603827
发表时间: 2016-07-28
期刊: The New England journal of medicine
影响因子: --
作者:
Marso SP;Daniels GH;Brown-Frandsen K;Kristensen P;Mann JF;Nauck MA;Nissen SE;Pocock S;Poulter NR;Ravn LS;Steinberg WM;Stockner M;Zinman B;Bergenstal RM;Buse JB;LEADER Steering Committee;LEADER Trial Investigators
通讯作者: LEADER Trial Investigators