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依帕列净分级剂量治疗 2 型糖尿病的疗效:一项真实世界研究。

Treatment outcomes of graded dose of empagliflozin in type-2 diabetes: A real world study.

机构信息

Department of Endocrinology, Center for Endocrinology, Diabetes, Arthritis and Rheumatism Super Speciality Clinics, New Delhi, India.

Department of Rheumatology, Center for Endocrinology, Diabetes, Arthritis and Rheumatism Super Speciality Clinics, New Delhi, India.

出版信息

Ann Afr Med. 2022 Jan-Mar;21(1):26-33. doi: 10.4103/aam.aam_69_20.

Abstract

BACKGROUND

Costs are important cause of therapeutic noncompliance in type-2 diabetes mellitus (T2DM). Half-tablet empagliflozin (EMPA)-25 mg has lowest monthly cost among all EMPA preparations; data is unavailable on efficacy of half EMPA-25. This study compared real world weight loss and glycaemic outcomes of 10 mg versus 12.5 mg versus 25 mg of EMPA.

METHODS

Data, retrospectively captured from records of 2 different centresfor patients > 35 years-age having T2DM on EMPA as part of standard pharmacotherapy for T2DM, having > 6 months follow-up data available was analysed. Patients were in 3-groups depending on EMPA dosage: Group 1 on EMPA 10 mg/day (1-tablet EMPA-10), Group-2 on EMPA 12.5 mg/day (half-tablet EMPA-25), and Group 3 on EMPA 25 mg/day (1-tablet EMPA-25). Primary endpoints were glycaemic efficacy and weight-loss.

RESULTS

Of 3601 records screened, data from 599 patients (184, 239 and 176 in Group-1, 2 and 3 respectively) was analysed. All 3 groups were comparable with regards to sex, blood pressure, haemoglobin, renal function, medications use. Group-3 were significantly older, had longest diabetes duration, highest HbA1c and lowest body mass index. Glycaemic efficacy was comparable among groups (ΔHbA1c Groups 1-3: -0.9 (-1.9 - 0.0), -1.0 (-1.8 - 0.5) and - 1.0 (-1.5 - 0.22], respectively; P = 0.363). Patients on EMPA 12.5 or 25 mg/d had significantly higher total (-1.4 [-3.0 -0.2] vs. -0.3 [-2.4 - 1.32] kg; P = 0.028) and percent weight-loss (-1.75% [-4.15 - 0.26] vs. -0.44% [-3.11 - 1.39]; P = 0.039), and significantly higherfraction achieving HbA1c < 5.7% (12% vs. 0; P = 0.021), compared to EMPA-10.

CONCLUSION

Half EMPA-25 is the most cost effective way of using EMPA in clinical practice.

摘要

背景

在 2 型糖尿病(T2DM)患者中,费用是导致治疗不依从的重要原因。在所有恩格列净制剂中,半片恩格列净(EMPA)-25 毫克的每月费用最低;关于半片 EMPA-25 的疗效数据尚不清楚。本研究比较了 EMPA 10 毫克、12.5 毫克和 25 毫克在体重减轻和血糖控制方面的真实世界疗效。

方法

从两个不同中心的记录中回顾性收集了年龄大于 35 岁的 T2DM 患者的数据,这些患者在 T2DM 标准药物治疗中使用 EMPA,有超过 6 个月的随访数据。根据 EMPA 剂量将患者分为三组:第 1 组 EMPA 10 毫克/天(1 片 EMPA-10),第 2 组 EMPA 12.5 毫克/天(半片 EMPA-25),第 3 组 EMPA 25 毫克/天(1 片 EMPA-25)。主要终点是血糖疗效和体重减轻。

结果

在筛选的 3601 份记录中,分析了 599 名患者的数据(第 1 组 184 名,第 2 组 239 名,第 3 组 176 名)。所有三组在性别、血压、血红蛋白、肾功能、药物使用方面均具有可比性。第 3 组患者年龄较大,糖尿病病程最长,HbA1c 最高,体重指数最低。三组间血糖疗效相当(ΔHbA1c:第 1 组-0.9(-1.9-0.0),第 2 组-1.0(-1.8-0.5),第 3 组-1.0(-1.5-0.22];P=0.363)。服用 EMPA 12.5 或 25 毫克/天的患者体重减轻幅度更大(总体重减轻:-1.4[-3.0-0.2]与-0.3[-2.4-1.32]kg;P=0.028),体重减轻百分比更高(-1.75%[-4.15-0.26]与-0.44%[-3.11-1.39];P=0.039),达到 HbA1c<5.7%的比例更高(12%与 0%;P=0.021),与 EMPA-10 相比。

结论

半片 EMPA-25 是 EMPA 在临床实践中最具成本效益的使用方式。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2a2/9020632/10dafdfc53d5/AAM-21-26-g001.jpg

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