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将1型糖尿病患者从其他基础胰岛素转换为德谷胰岛素:有效性和安全性的真实世界数据

Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety.

作者信息

Ponzani Paola, Berra Cesare, Di Lelio Alessandra, Del Sindaco Paola, Di Loreto Chiara, Reggiani Francesco, Lucisano Giuseppe, Rossi Maria Chiara

机构信息

SSD Endocrinologia, Diabetologia e Malattie Metaboliche, ASL3 Genovese, Genoa, Italy.

Humanitas Research Institute, Rozzano, MI, Italy.

出版信息

Diabetes Ther. 2020 Jan;11(1):97-105. doi: 10.1007/s13300-019-00722-y. Epub 2019 Nov 9.

Abstract

INTRODUCTION

Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patients with type 1 diabetes under routine clinical practice conditions.

METHODS

This was an observational longitudinal multicenter study. A retrospective chart review of all patients with type 1 diabetes who were switched from basal insulin to IDeg was performed, and temporal trends in clinical outcomes were assessed.

RESULTS

Data obtained from 195 patients, with a median age of 42.8 [interquartile range (IQR) 24.6-56.4] years and a median diabetes duration of 16 (IQR 10.0-28) years, were analyzed. Median follow-up was 9.5 (IQR 7.7-11.3) months. Improvements were found in glycated hemoglobin (- 0.34%; p  < 0.0001), fasting blood glucose (- 24.82 mg/dL; p  < 0.0001), post-prandial glucose (- 17.23 mg/dL; p  = 0.0009), glycemic variability as indicated by standard deviation of blood glucose (- 5.67 mg/dL; p  < 0.0001) and high blood glucose index (- 3.77; p < 0.0001). Body weight and body mass index remained substantially stable during the follow-up (- 0.18 kg; p = 0.56 and - 0.12; p = 0.42, respectively). Risk of nocturnal hypoglycemia decreased by 52% [incidence rate ratio 0.48; 95% confidence interval (CI) 0.29-0.77] and risk of total hypoglycemic episodes by 41% (incidence ratio 0.59; 95% CI 0.45-0.83). Basal and short-acting insulin doses decreased by - 1.4 and - 3.1 IU, respectively.

CONCLUSION

Switching patients with type 1 diabetes to IDeg from other basal insulins was associated with relevant improvements in metabolic control and glycemic variability without weight gain; the risk of hypoglycemic episodes also significantly declined.

FUNDING

Novo Nordisk S.p.A. unconditional grant.

摘要

引言

关于德谷胰岛素(IDeg)在糖尿病患者中的有效性和安全性的真实世界证据是当务之急。因此,我们评估了在常规临床实践条件下,IDeg对1型糖尿病患者的有效性和安全性,包括对代谢控制、血糖变异性、体重增加和低血糖的影响。

方法

这是一项观察性纵向多中心研究。对所有从基础胰岛素转换为IDeg的1型糖尿病患者进行回顾性病历审查,并评估临床结局的时间趋势。

结果

分析了195例患者的数据,患者中位年龄为42.8岁[四分位间距(IQR)24.6 - 56.4岁],糖尿病病程中位数为16年(IQR 10.0 - 28年)。中位随访时间为9.5个月(IQR 7.7 - 11.3个月)。糖化血红蛋白(-0.34%;p < 0.0001)、空腹血糖(-24.82mg/dL;p < 0.0001)、餐后血糖(-17.23mg/dL;p = 0.0009)、以血糖标准差表示的血糖变异性(-5.67mg/dL;p < 0.0001)和高血糖指数(-3.77;p < 0.0001)均有改善。随访期间体重和体重指数基本保持稳定(分别为-0.18kg;p = 0.56和-0.12;p = 0.42)。夜间低血糖风险降低了52%[发病率比0.48;95%置信区间(CI)0.29 - 0.77],总低血糖事件风险降低了41%(发病率比0.59;95%CI 0.45 - 0.83)。基础胰岛素和短效胰岛素剂量分别减少了-1.4和-3.1IU。

结论

将1型糖尿病患者从其他基础胰岛素转换为IDeg与代谢控制和血糖变异性的相关改善有关,且无体重增加;低血糖事件的风险也显著下降。

资助

诺和诺德公司无条件资助。

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