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在二甲双胍和/或格列齐特联合治疗控制不佳的 2 型糖尿病患者中,用卡格列净替换西格列汀的疗效和安全性:SITA-CANA Switch 研究。

Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study.

机构信息

Internal medicine, Hospital Costa del Sol, autovia A7, Málaga, E-29030 Marbella, Spain.

Hospital Regional Universitario (IBIMA), Málaga and CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Malaga, Spain.

出版信息

Diabetes Metab. 2018 Sep;44(4):373-375. doi: 10.1016/j.diabet.2018.05.005. Epub 2018 May 22.

Abstract

AIM

To analyze the efficacy and safety of replacing sitagliptin with canagliflozin in patients with type 2 diabetes (T2D) and poor metabolic control despite treatment with sitagliptin in combination with metformin and/or gliclazide.

MATERIALS AND METHODS

In this multicentre observational, retrospective, 26-week clinical study of patients with T2D and poor glycaemic control (HbA1c: 7.5-9.5%) treated with sitagliptin in combination with metformin and/or gliclazide, sitagliptin (and gliclazide if appropriate) were replaced by canagliflozin. The main outcome of the study was the proportion of patients who achieved good glycaemic control (HbA1c<7%) by the end of the study.

RESULTS

The study sample comprised 50 patients (baseline HbA1c 8.0±0.6%) treated with sitagliptin 100mg/day, 14 of whom were also taking gliclazide 60mg/day while 38 were taking metformin 1700mg/day. Sitagliptin treatment was replaced by either canagliflozin 100mg (n=17) or 300mg (n=33). After 26 weeks of follow-up, these patients presented with significant decreases in HbA1c (-1.1%; P<0.000), weight (-3.89kg; P<0.000), BMI (-1.37kg/m; P<0.022), abdominal circumference (-5.42cm; P<0.004), systolic and diastolic blood pressure (-5.3mmHg and -4.4mmHg, respectively; P=0.005), triglycerides (-42mg/dL; P=0.005) and LDL/HDL cholesterol ratio (-0.34; P=0.005). By the end of the study, 42% of patients had achieved HbA1c levels<7%.

CONCLUSION

In patients with T2D poorly controlled with sitagliptin, whether alone or in combination with metformin and/or gliclazide, replacing it with canagliflozin may be a simple yet effective intensification strategy. Our results, which may have important implications for clinical practice, now need to be confirmed in larger observational studies.

摘要

目的

分析在接受西格列汀联合二甲双胍和/或格列齐特治疗但代谢控制仍不佳的 2 型糖尿病(T2D)患者中,替换为卡格列净的疗效和安全性。

材料和方法

在这项针对 T2D 患者的多中心观察性、回顾性、26 周临床研究中,患者在接受西格列汀联合二甲双胍和/或格列齐特治疗时血糖控制不佳(HbA1c:7.5-9.5%),用卡格列净替换西格列汀(如果需要,也替换格列齐格)。该研究的主要终点是研究结束时达到良好血糖控制(HbA1c<7%)的患者比例。

结果

该研究样本包括 50 名患者(基线 HbA1c 8.0±0.6%),每天服用 100mg 西格列汀,其中 14 名患者还服用 60mg 格列齐特,38 名患者服用 1700mg 二甲双胍。西格列汀治疗被替换为卡格列净 100mg(n=17)或 300mg(n=33)。经过 26 周的随访,这些患者的 HbA1c 显著下降(-1.1%;P<0.000),体重下降(-3.89kg;P<0.000),BMI 下降(-1.37kg/m;P<0.022),腹围下降(-5.42cm;P<0.004),收缩压和舒张压分别下降(-5.3mmHg 和-4.4mmHg,P=0.005),甘油三酯下降(-42mg/dL;P=0.005),LDL/HDL 胆固醇比值下降(-0.34;P=0.005)。研究结束时,42%的患者 HbA1c 水平<7%。

结论

在接受西格列汀治疗但代谢控制仍不佳的 T2D 患者中,无论是单独使用还是与二甲双胍和/或格列齐特联合使用,替换为卡格列净可能是一种简单而有效的强化策略。我们的结果可能对临床实践具有重要意义,现在需要在更大规模的观察性研究中得到证实。

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