Abstract

Patients with type 2 diabetes mellitus (T2DM) have a very high risk of cardiovascular related events, and reducing complications is an important evaluation criterion of efficacy and safety of hypoglycemic drugs. Previous studies have shown that the dipeptidyl peptidase-4 (DPP-4) inhibitors (DPP4i), such as sitagliptin, might reduce the incidence of major cardiovascular events (MACEs). However, the safety and efficacy of sitagliptin remains controversial, especially the safety for cardiovascular related events. Here, a systematic review was conducted to assess the cardiovascular safety of sitagliptin in T2DM patients. The literature research dating up to October 2018 was performed in the electronic database. The clinical trials about sitagliptin for T2DM patients were included. Two reviewers independently screened literature according to the inclusion and exclusion criteria. The primary outcome was the MACE, and the secondary outcome was all-cause mortality. Finally, 32 clinical trials composed of 16082 T2DM patients were included in this meta-analysis. The results showed that: there was no significant difference between sitagliptin group and the control group on MACE (odds ratio (OR) = 0.85, 95% confidence intervals (CIs) = 0.63–1.15), myocardial infarction (MI) (OR = 0.66, 95% CI = 0.38–1.16), stroke (OR = 0.83, 95% CI = 0.44–1.54) and mortality (OR = 0.52, 95% CI = 0.26–1.07). These results demonstrated that sitagliptin did not increase the risk of cardiovascular events in patients with T2DM.

Highlights

  • IntroductionAccepted Manuscript Online: Version of Record published: Type 2 diabetes mellitus (T2DM) is a progressive disease characterized by insulin deficiency and insulin resistance

  • Received: 11 April 2019Revised: 29 May 2019Accepted: 18 June 2019Accepted Manuscript Online: Version of Record published: Type 2 diabetes mellitus (T2DM) is a progressive disease characterized by insulin deficiency and insulin resistance

  • Among the articles identified in the initial research, only those meeting the following criteria were selected for subsequent analysis: (i) patients with T2DM; (ii) compared sitagliptin with placebo or active drugs different from other DPP-4 inhibitor (DPP4i); (iii) clinical trials with duration of at least 24 weeks

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Summary

Introduction

Accepted Manuscript Online: Version of Record published: Type 2 diabetes mellitus (T2DM) is a progressive disease characterized by insulin deficiency and insulin resistance. It is associated with a high risk of microvascular, cardiovascular and other complications (such as depression, a mental disorder with unclear pathogenesis) [1,2,3,4]. Most interventions for T2DM are designed to control the blood glucose level. These interventions pay little attention to other risk factors and rarely meet the multifaceted needs of patients with T2DM [5,6]. The European Society of Cardiology (ESC) Guidelines on diabetes, pre-diabetes and cardiovascular disease (CVD) emphasize the need for a stringent approach in treating patients with diabetes, suggesting the importance of reducing the cardiovascular events [7,8]

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