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Meta-Analysis
. 2018 Dec;97(51):e13710.
doi: 10.1097/MD.0000000000013710.

PRISMA-efficacy and safety of lixisenatide for type 2 diabetes mellitus: A meta-analysis of randomized controlled trials

Zhen-Gang Wei  1   2   3 , Man-Cai Wang  1   2   3 , Hui-Han Zhang  1   2   3 , Zhe-Yuan Wang  1   2   3 , Gen-Nian Wang  1   2   3 , Feng-Xian Wei  1   2   3 , Ya-Wu Zhang  1   2   3 , Xiao-Dong Xu  1   2   3 , You-Cheng Zhang  1   2   3
Affiliations
Meta-Analysis

PRISMA-efficacy and safety of lixisenatide for type 2 diabetes mellitus: A meta-analysis of randomized controlled trials

Zhen-Gang Wei et al. Medicine (Baltimore). 2018 Dec.

Abstract

Objective: We aimed to systematically evaluate the efficacy and safety of lixisenatide in patients with type 2 diabetes mellitus.

Methods: PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, Google, Web of Science and the Chinese Science Citation Database were searched up to March 2018. Randomized controlled trials determining the efficacy and safety of lixisenatide in patients with type 2 diabetes mellitus were eligible for inclusion. Two authors independently extracted the data in a prespecified Microsoft Excel spreadsheet. A meta-analysis was performed using Review Manager 5.3 software. Weighted mean difference (WMD) and relative risk (RR) together with their corresponding 95% confidence intervals (CIs) were estimated, and only the random effects model was used in order to achieve a more conservative estimate of the efficacy and safety.

Results: Fourteen multicenter randomized controlled trials involving 11,947 patients were eligible for inclusion. Compared to placebo, lixisenatide could more significantly reduce the level of HbA1c (WMD=-0.44; 95% confidence interval [CI] [-0.55,-0.33]), and a higher proportion of lixisenatide-treated patients achieved the HbA1c level of < 7.0% (RR = 1.89, 95% CI [1.75-2.03]) and < 6.5% (RR = 3.03, 95% CI [2.54-3.63]) than the placebo-treated patients. Lixisenatide was also associated with a significant reduction in fasting plasma glucose and 2-hour postprandial plasma glucose levels. The risks for any adverse events, gastrointestinal adverse events, and symptomatic hypoglycemia significantly increased in the lixisenatide-treatedment group compared to those in the placebo group. However, lixisenatideit did not increase the risks of serious adverse events, death, or severe hypoglycemia.

Conclusions: Lixisenatide was more effective than placebo in patients with type 2 diabetes mellitus, and the mild-to-moderate adverse events were found to be tolerated during the follow-up.

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Conflict of interest statement

Conflicts of Interest and Source of Funding: The work was supported by Gansu province Science and Technology Support Program (1204FKCA138). No potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1
The flow chart of trial selection.
Figure 2
Figure 2
The risk of bias in this meta-analysis.
Figure 3
Figure 3
The meta-analysis of HbA1c levels at the end of the follow-up ∗The study by Rosenstock et al showed obvious heterogeneity with others, according to the forest plot. After the study was removed, we obtained results consistent with those obtained before.
Figure 4
Figure 4
The meta-analysis of HbA1c < 7% ∗ The study by Seino et al showed obvious heterogeneity with others, according to the forest plot. After the study was removed, we obtained results consistent with those obtained before.
Figure 5
Figure 5
The meta-analysis of HbA1c < 6.5%.
See this image and copyright information in PMC

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