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格列汀类药物的安全性:2018年的最新数据。

The safety of gliptins : updated data in 2018.

作者信息

Scheen André Jacques

机构信息

a Division of Diabetes, Nutrition and Metabolic Disorders, Department of Medicine , CHU Sart Tilman, University of Liège , Liège , Belgium.

b Division of Clinical Pharmacology , Center for Interdisciplinary Research on Medicines (CIRM) , Liège , Belgium.

出版信息

Expert Opin Drug Saf. 2018 Apr;17(4):387-405. doi: 10.1080/14740338.2018.1444027. Epub 2018 Mar 3.

Abstract

INTRODUCTION

Dipeptidyl peptidase-4 inhibitors (DPP-4is) are generally considered as glucose-lowering agents with a safe profile in type 2 diabetes.

AREAS COVERED

An updated review of recent safety data from randomised controlled trials, observational studies, meta-analyses, pharmacovigilance reports regarding alogliptin, linagliptin, saxagliptin, sitagliptin, and vildagliptin, with a special focus on risks of hypoglycemia, pancreatitis and pancreatic cancer, major cardiovascular events, hospitalisation for heart failure and other new safety issues, such as bone fractures and arthralgia. The safety of DPP-4i use in special populations, elderly patients, patients with renal impairment, liver disease or heart failure, will also be discussed.

EXPERT OPINION

The good tolerance/safety profile of DPP-4is has been largely confirmed, including in more fragile populations, with no gastrointestinal adverse effects and a minimal risk of hypoglycemia. DPP-4is appear to be associated with a small increased incidence of acute pancreatitis in placebo-controlled trials, although most observational studies are reassuring. Most recent studies with DPP-4is do not confirm the increased risk of hospitalisation for heart failure reported with saxagliptin in SAVOR-TIMI 53, but further post-marketing surveillance is still recommended. New adverse events have been reported such as arthralgia, yet a causal relationship remains unclear.

摘要

引言

二肽基肽酶-4抑制剂(DPP-4i)通常被认为是2型糖尿病中具有安全特性的降糖药物。

涵盖领域

对来自随机对照试验、观察性研究、荟萃分析、有关阿格列汀、利格列汀、沙格列汀、西格列汀和维格列汀的药物警戒报告的近期安全性数据进行更新综述,特别关注低血糖、胰腺炎和胰腺癌、主要心血管事件、因心力衰竭住院以及其他新的安全性问题,如骨折和关节痛。还将讨论DPP-4i在特殊人群、老年患者、肾功能损害、肝病或心力衰竭患者中的使用安全性。

专家意见

DPP-4i良好的耐受性/安全性已在很大程度上得到证实,包括在更脆弱的人群中,无胃肠道不良反应且低血糖风险极小。在安慰剂对照试验中,DPP-4i似乎与急性胰腺炎发病率的小幅增加有关,尽管大多数观察性研究令人放心。DPP-4i的最新研究并未证实沙格列汀在SAVOR-TIMI 53研究中报道的因心力衰竭住院风险增加,但仍建议进行进一步的上市后监测。已报告了新的不良事件,如关节痛,但因果关系仍不明确。

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