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一项回顾性真实世界研究:达格列净对比其他口服降糖药与二甲双胍联用治疗 2 型糖尿病患者。

A retrospective real-world study of dapagliflozin versus other oral antidiabetic drugs added to metformin in patients with type 2 diabetes.

机构信息

IQVIA, Cambridge, MA. Email:

出版信息

Am J Manag Care. 2018 Apr;24(8 Suppl):S132-S137.

PMID:29693359
Abstract

OBJECTIVES

The efficacy of dapagliflozin as add-on therapy to metformin has been assessed in randomized trials. However, its effectiveness has not been assessed in a US real-world setting.

METHODS

Electronic medical record (EMR) data were used to compare clinical outcomes among patients with type 2 diabetes (T2D) treated with dapagliflozin and metformin with or without other oral antidiabetic drugs (D + M ± OAD), versus metformin with at least 1 other OAD (M + OAD). Adult patients with T2D on these regimens from January 01, 2014, to February 28, 2015, were identified in a US EMR database, with the date of first prescription for dapagliflozin (D + M ± OAD) or other OAD (M + OAD) as the index date. Patients were observed for 12 months before the index date (baseline) and 12 months afterward (ie, follow-up). Patients in the M + OAD group were propensity score matched 1:1 to those in the D + M ± OAD group. Outcomes included change in glycated hemoglobin (A1C) level, weight, and systolic and diastolic blood pressures (SBP/DBP) from baseline to follow-up.

RESULTS

A total of 1093 patients receiving M + OAD were matched to 1093 patients receiving D + M ± OAD. Compared with those given M + OAD, patients given D + M ± OAD had a greater reduction in A1C level (mean, -1.0% vs -0.7%; P <.01), greater weight loss (-1.8 kg vs -0.7 kg, P <.01), and greater change in SBP (-3.6 mm Hg vs -0.1 mm Hg, P <.01) and DBP (-2.0 mm Hg vs -0.6 mm Hg, P <.01) from baseline to follow-up.

CONCLUSIONS

In current US clinical practice, patients receiving D + M ± OAD had greater reductions in important clinical outcomes of T2D-A1C level, weight loss, and blood pressure-versus patients receiving M + OAD. This study supports the use of dapagliflozin as add-on therapy to metformin with or without other OADs for patients with T2D.

摘要

目的

达格列净作为二甲双胍的附加疗法在随机试验中已被证明有效。然而,它在真实的美国环境中的有效性尚未得到评估。

方法

使用电子病历(EMR)数据比较了 2014 年 1 月 1 日至 2015 年 2 月 28 日期间接受达格列净和二甲双胍加或不加其他口服降糖药(D+M±OAD)与接受至少一种其他口服降糖药(M+OAD)治疗的 2 型糖尿病(T2D)患者的临床结局。从美国 EMR 数据库中确定了这些方案的成年 T2D 患者,达格列净(D+M±OAD)或其他口服降糖药(M+OAD)的首次处方日期为索引日期。在索引日期前 12 个月(基线)和之后 12 个月(即随访)观察患者。将 M+OAD 组的患者与 D+M±OAD 组的患者进行 1:1 倾向评分匹配。结局包括从基线到随访时糖化血红蛋白(A1C)水平、体重以及收缩压和舒张压(SBP/DBP)的变化。

结果

共有 1093 例接受 M+OAD 的患者与 1093 例接受 D+M±OAD 的患者匹配。与接受 M+OAD 的患者相比,接受 D+M±OAD 的患者 A1C 水平降低更明显(平均-1.0%比-0.7%,P<0.01),体重减轻更多(-1.8 千克比-0.7 千克,P<0.01),SBP(-3.6 毫米汞柱比-0.1 毫米汞柱,P<0.01)和 DBP(-2.0 毫米汞柱比-0.6 毫米汞柱,P<0.01)从基线到随访的变化更大。

结论

在当前的美国临床实践中,与接受 M+OAD 的患者相比,接受 D+M±OAD 的患者的 2 型糖尿病重要临床结局(A1C 水平、体重减轻和血压)改善更为显著。这项研究支持将达格列净作为二甲双胍的附加疗法,与或不与其他口服降糖药联合用于治疗 2 型糖尿病患者。

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