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2013年至2017年批准的新型抗糖尿病药物控制糖尿病患者糖化血红蛋白疗效和安全性的系统评价

Systematic Review of Efficacy and Safety of Newer Antidiabetic Drugs Approved from 2013 to 2017 in Controlling HbA1c in Diabetes Patients.

作者信息

Palanisamy Sivanandy, Yien Emily Lau Hie, Shi Ling Wen, Si Low Yi, Qi See Hui, Ling Laura Soon Cheau, Lun Teng Wai, Chen Yap Nee

机构信息

Department of Pharmacy Practice, International Medical University, Kuala Lumpur 57000, Malaysia.

School of Pharmacy, International Medical University, Kuala Lumpur 57000, Malaysia.

出版信息

Pharmacy (Basel). 2018 Jun 27;6(3):57. doi: 10.3390/pharmacy6030057.

DOI:10.3390/pharmacy6030057
PMID:29954090
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6164486/
Abstract

Type 2 Diabetes Mellitus (T2DM) is the most common form of diabetes mellitus and accounts for about 95% of all diabetes cases. Many newer oral as well as parenteral antidiabetic drugs have been introduced in to the market in recent years to control hyperglycemic conditions in diabetes patients and many of these drugs produce potential side effects in diabetes patients. Hence, this systematic review was aimed to analyze and compare the efficacy and safety of oral antidiabetic agents in controlling HbA1c in T2DM patients, that were approved by the United States-Food and Drug Administration (US-FDA) from 2013 to 2017. All randomized controlled, double-blind trials published in English during the search period involving the newer antidiabetic agents were selected. In the outcome assessment comparison, semaglutide demonstrated the highest efficacy in lowering HbA1c, with a 1.6% reduction ( < 0.0001) when given at a dose of 1.0 mg. The safety profile of all the agents as compared to placebo or control were similar, with no or slight increase in the occurrence of adverse events (AEs) but no fatal reaction was reported. The most common AEs of all the antidiabetic agents were gastrointestinal in nature, with several cases of hypoglycemic events. However, among all these agents, semaglutide seems to be the most efficacious drug to improve glycemic control in terms of HbA1c. Alogliptin has the least overall frequency of AEs compared to other treatment groups.

摘要

2型糖尿病(T2DM)是糖尿病最常见的类型,约占所有糖尿病病例的95%。近年来,许多新型口服和注射用抗糖尿病药物已投放市场,用于控制糖尿病患者的高血糖状况,其中许多药物会给糖尿病患者带来潜在的副作用。因此,本系统评价旨在分析和比较2013年至2017年期间美国食品药品监督管理局(US-FDA)批准的口服抗糖尿病药物在控制T2DM患者糖化血红蛋白(HbA1c)方面的疗效和安全性。检索期间发表的所有涉及新型抗糖尿病药物的英文随机对照双盲试验均被纳入。在疗效评估比较中,司美格鲁肽在降低HbA1c方面显示出最高疗效,剂量为1.0 mg时降低了1.6%(<0.0001)。与安慰剂或对照组相比,所有药物的安全性相似,不良事件(AE)发生率无增加或略有增加,但未报告致命反应。所有抗糖尿病药物最常见的AE为胃肠道反应,有几例低血糖事件。然而,在所有这些药物中,就HbA1c而言,司美格鲁肽似乎是改善血糖控制最有效的药物。与其他治疗组相比,阿格列汀的AE总发生率最低。

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本文引用的文献

1
Semaglutide seems to be more effective the other GLP-1Ras.司美格鲁肽似乎比其他胰高血糖素样肽-1受体激动剂更有效。
Ann Transl Med. 2017 Dec;5(24):505. doi: 10.21037/atm.2017.11.10.
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Semaglutide-the "" in the field of glucagon-like peptide-1 receptor agonists?司美格鲁肽——胰高血糖素样肽-1受体激动剂领域的“佼佼者”? (注:原文表述不太完整准确,这里是按大概意思翻译,补充了“佼佼者”这样的意译以使译文更通顺表意。)
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Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.每周一次司美格鲁肽对比艾塞那肽 ER 治疗 2 型糖尿病患者的疗效和安全性(SUSTAIN 3):一项 56 周、开放标签、随机临床试验。
Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.
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Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.评估每周一次度拉糖肽对日本2型糖尿病患者自我报告结局的影响:在两项随机研究中与利拉鲁肽、甘精胰岛素及安慰剂的比较
Health Qual Life Outcomes. 2017 Jun 12;15(1):123. doi: 10.1186/s12955-017-0696-7.
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Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial.每周一次司美格鲁肽对比每日一次西格列汀作为二甲双胍、噻唑烷二酮类药物或两者联合治疗的基础上加用药物,治疗 2 型糖尿病患者的疗效和安全性(SUSTAIN 2):一项 56 周、双盲、3a 期、随机试验。
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Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data.基于心血管疾病史或心血管危险因素的2型糖尿病患者使用卡格列净的疗效和安全性:汇总数据的事后分析
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Efficacy and safety analyses across 4 subgroups combining low and high age and body mass index groups in Japanese phase 3 studies of dulaglutide 0.75 mg after 26 weeks of treatment.在日本进行的度拉糖肽0.75毫克3期研究中,治疗26周后,对年龄和体重指数高低组合的4个亚组进行疗效和安全性分析。
Endocr J. 2017 Apr 29;64(4):449-456. doi: 10.1507/endocrj.EJ16-0428. Epub 2017 Mar 7.
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Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.每周一次司美格鲁肽单药治疗与安慰剂在 2 型糖尿病患者中的疗效和安全性(SUSTAIN 1):一项双盲、随机、安慰剂对照、平行分组、多国、多中心 3a 期临床试验。
Lancet Diabetes Endocrinol. 2017 Apr;5(4):251-260. doi: 10.1016/S2213-8587(17)30013-X. Epub 2017 Jan 17.
9
The pharmacokinetics and pharmacodynamics of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.阿格列汀在2型糖尿病儿童、青少年及成人中的药代动力学和药效学。
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Diabetes Obes Metab. 2017 Mar;19(3):463-467. doi: 10.1111/dom.12837. Epub 2017 Jan 19.