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恩格列净的疗效和安全性:来自沙特阿拉伯的“真实世界”经验。

Efficacy and safety of empagliflozin: a "real-world" experience from Saudi Arabia.

机构信息

From the Department of Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.

From the Department of Endocrinology, Imperial College London Diabetes Centre, Al Ain, United Arab Emirates.

出版信息

Ann Saudi Med. 2023 Jan-Feb;43(1):50-56. doi: 10.5144/0256-4947.2023.50. Epub 2023 Feb 2.

DOI:10.5144/0256-4947.2023.50
PMID:36739502
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9899336/
Abstract

BACKGROUND

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are new agents for treating type 2 diabetes. In addition to the glycemic benefits, these agents provide cardiorenal protection in patients with diabetes and without diabetes. There is consistent evidence that these agents increase the risk of genitourinary infections and dehydration, but randomized controlled trials have not included patients from the Middle East.

OBJECTIVES

Determine the efficacy and safety of empagliflozin, specifically whether the genitourinary infection risk differs in our population and whether there is an increased risk of dehydration, ketoacidosis, hypoglycemia, and hospitalization with fasting.

DESIGN

Retrospective review of medical records.

SETTINGS

Department of medicine at tertiary care center.

PATIENTS AND METHODS

We reviewed the electronic records of patients with type 2 diabetes who took empagliflozin from 1 December 2018 to 30 November 2019. We collected safety and efficacy data for 12 months from the initiation of treatment.

MAIN OUTCOMES MEASURES

Glycemic and weight loss efficacy, risk of hospitalization due to hypoglycemia, dehydration, and genitourinary infections.

SAMPLE SIZE

637 patients.

RESULTS

We observed an improvement in glycated hemoglobin, a 4.2% weight loss, improved left ventricular function, stable serum creatinine, and reduced albuminuria. Our patients did not have an increased risk of genitourinary infections, hypoglycemia, dehydration, ketoacidosis, or hospitalizations. Fasting did not increase the incidence of adverse events.

CONCLUSIONS

Empagliflozin is safe and effective in our local population. We hypothesize that glycosuria induced by empagliflozin is not the sole contributor to the increased risk of genitourinary infections. Local hygiene and circumcision might reduce this risk. Empagliflozin can be used safely during fasting.

LIMITATIONS

Retrospective design.

CONFLICT OF INTEREST

None.

摘要

背景

钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂是治疗 2 型糖尿病的新型药物。除了血糖益处外,这些药物还为患有和不患有糖尿病的患者提供心脏和肾脏保护。有一致的证据表明,这些药物会增加泌尿生殖系统感染和脱水的风险,但随机对照试验并未纳入来自中东的患者。

目的

确定恩格列净的疗效和安全性,特别是泌尿生殖系统感染风险在我们人群中是否不同,以及是否存在脱水、酮症酸中毒、低血糖和禁食相关住院风险增加的情况。

设计

回顾性病历审查。

地点

三级护理中心内科。

患者和方法

我们回顾了 2018 年 12 月 1 日至 2019 年 11 月 30 日期间服用恩格列净的 2 型糖尿病患者的电子病历。我们从治疗开始收集了 12 个月的安全性和疗效数据。

主要观察指标

血糖和体重减轻疗效、因低血糖、脱水和泌尿生殖系统感染住院的风险。

样本量

637 例患者。

结果

我们观察到糖化血红蛋白改善、体重减轻 4.2%、左心室功能改善、血清肌酐稳定和白蛋白尿减少。我们的患者没有增加泌尿生殖系统感染、低血糖、脱水、酮症酸中毒或住院的风险。禁食并未增加不良事件的发生率。

结论

恩格列净在我们的本地人群中是安全有效的。我们假设恩格列净诱导的糖尿不是泌尿生殖系统感染风险增加的唯一原因。当地卫生和割礼可能会降低这种风险。恩格列净可以在禁食期间安全使用。

局限性

回顾性设计。

利益冲突

无。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/52fd8ce1a79e/0256-4947.2023.50-fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/52cec548f6fd/0256-4947.2023.50-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/d7648a4803a6/0256-4947.2023.50-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/b0aae93d8d49/0256-4947.2023.50-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/76fcfde9b1fc/0256-4947.2023.50-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/23bd673831cd/0256-4947.2023.50-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/52fd8ce1a79e/0256-4947.2023.50-fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/52cec548f6fd/0256-4947.2023.50-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/d7648a4803a6/0256-4947.2023.50-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/b0aae93d8d49/0256-4947.2023.50-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/76fcfde9b1fc/0256-4947.2023.50-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/23bd673831cd/0256-4947.2023.50-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b855/9899336/52fd8ce1a79e/0256-4947.2023.50-fig6.jpg

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