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替尔泊肽用于2型糖尿病

Tirzepatide for type 2 diabetes.

作者信息

Anderson Sarah L, Marrs Joel C

机构信息

Clinical Care Options, Reston, VA, USA.

Department of Clinical Pharmacy & Translational Science, College of Pharmacy, The University of Tennessee Health Science Center, Nashville, TN, USA.

出版信息

Drugs Context. 2023 Aug 22;12. doi: 10.7573/dic.2023-6-1. eCollection 2023.

DOI:10.7573/dic.2023-6-1
PMID:37664792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10470858/
Abstract

One in ten adults worldwide is living with diabetes, with 95% having type 2 diabetes (T2D). Sustained glycaemic control in people with T2D is difficult to achieve despite recent advances in T2D management with the advent of glucagon-like peptide 1 receptor agonists (GLP1RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i). Tirzepatide represents a first-in-class agent as a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP1RA to be approved in the USA and Europe for the treatment of T2D. This narrative review intends to list and discuss the glycaemic efficacy, key safety and weight loss outcomes related to the treatment of T2D with tirzepatide. Tirzepatide has been evaluated in five published clinical trials (=6278) within the SURPASS clinical trial programme, with a focus on glycaemic control and weight loss. These trials have demonstrated significant improvements in glycosylated haemoglobin (-1.24% to -2.11% placebo and -0.6% to -1.14% active comparator) and weight (up to 15.5 kg placebo or active comparator) in patients with T2D. Notably, tirzepatide exhibited superior glycaemic control and weight loss when compared directly with a GLP1RA. Adverse events with the use of tirzepatide are similar to other approved GLP1RA and are predominantly gastrointestinal (nausea, vomiting). The tirzepatide cardiovascular outcomes trial (SURPASS-CVOT) is in progress and is expected to be completed in the fall of 2024. Tirzepatide represents an attractive new option and first-in-class agent for the treatment of T2D in people unable to achieve their glycaemic or weight management goals.

摘要

全球十分之一的成年人患有糖尿病,其中95%为2型糖尿病(T2D)。尽管随着胰高血糖素样肽1受体激动剂(GLP1RA)和钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)的出现,T2D管理取得了最新进展,但T2D患者仍难以实现持续的血糖控制。替尔泊肽是首个获批在美国和欧洲用于治疗T2D的双重葡萄糖依赖性促胰岛素多肽(GIP)/GLP1RA类药物。本叙述性综述旨在列出并讨论与替尔泊肽治疗T2D相关的血糖疗效、关键安全性和体重减轻结果。在SURPASS临床试验项目中,已在五项已发表的临床试验(n = 6278)中对替尔泊肽进行了评估,重点是血糖控制和体重减轻。这些试验表明,T2D患者的糖化血红蛋白有显著改善(安慰剂组降低1.24%至2.11%,活性对照药组降低0.6%至1.14%),体重也有显著减轻(安慰剂组或活性对照药组最多减轻15.5 kg)。值得注意的是,与GLP1RA直接比较时,替尔泊肽显示出更好的血糖控制和体重减轻效果。使用替尔泊肽的不良事件与其他获批的GLP1RA相似,主要是胃肠道反应(恶心、呕吐)。替尔泊肽心血管结局试验(SURPASS-CVOT)正在进行中,预计2024年秋季完成。对于无法实现血糖或体重管理目标的T2D患者,替尔泊肽是一种有吸引力的新选择和首个此类药物。

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本文引用的文献

1
American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm - 2023 Update.美国临床内分泌学会共识声明:全面 2 型糖尿病管理算法-2023 年更新。
Endocr Pract. 2023 May;29(5):305-340. doi: 10.1016/j.eprac.2023.02.001.
2
9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023.9. 血糖治疗的药物学方法:2023 年糖尿病的护理标准。
Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.
3
Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).2022 年美国糖尿病协会(ADA)和欧洲糖尿病研究协会(EASD)的共识报告:2 型糖尿病患者高血糖管理。
Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
4
Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial.替尔泊肽单药治疗与度拉鲁肽治疗日本 2 型糖尿病患者的疗效和安全性比较(SURPASS J-单药):一项双盲、多中心、随机、3 期临床试验。
Lancet Diabetes Endocrinol. 2022 Sep;10(9):623-633. doi: 10.1016/S2213-8587(22)00188-7. Epub 2022 Jul 30.
5
Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial.在日本,对于单药口服降糖药物控制不佳的 2 型糖尿病患者,添加替西帕肽的安全性和有效性(SURPASS J-combo):一项多中心、随机、开放标签、平行分组、3 期临床试验。
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JAMA. 2022 Feb 8;327(6):534-545. doi: 10.1001/jama.2022.0078.
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Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.司美格鲁肽与甘精胰岛素治疗 2 型糖尿病合并心血管高风险(SURPASS-4):一项随机、开放标签、平行分组、多中心、3 期临床试验。
Lancet. 2021 Nov 13;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7. Epub 2021 Oct 18.
9
Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial.每周一次替西帕肽与每日一次德谷胰岛素联用,或不联用 SGLT2 抑制剂,作为二甲双胍的附加疗法治疗 2 型糖尿病患者(SURPASS-3):一项随机、开放标签、平行分组、3 期临床试验。
Lancet. 2021 Aug 14;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4. Epub 2021 Aug 6.
10
Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.新型双重 GIP 和 GLP-1 受体激动剂替西帕肽在 2 型糖尿病患者中的疗效和安全性(SURPASS-1):一项双盲、随机、3 期临床试验。
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