Mathieu Chantal, Kozlovski Plamen, Paldánius Päivi M, Foley James E, Modgill Vikas, Evans Marc, Serban Carmen
Katholieke Universiteit Leuven, Leuven, Belgium.
Novartis Pharma AG, Basel, Switzerland.
Eur Endocrinol. 2017 Aug;13(2):68-72. doi: 10.17925/EE.2017.13.02.68. Epub 2017 Aug 22.
Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.
就临床应用而言，维格列汀是研究最为广泛的二肽基肽酶-4（DPP-4）抑制剂之一。在过去十年中，已积累了大量有关维格列汀在2型糖尿病（T2DM）患者中获益风险情况的证据。在本文中，我们回顾了维格列汀临床研发项目中有关其安全性的累积证据，以及该药物上市后监测期间发现的罕见药物不良反应报告。在各项临床研究中，维格列汀的总体安全性和耐受性与安慰剂相似，广泛T2DM患者群体的真实世界数据也证实了这一点，这使得像维格列汀这样的DPP-4抑制剂成为治疗T2DM患者的安全选择。
