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Review
. 2018 Oct;97(43):e12843.
doi: 10.1097/MD.0000000000012843.

Efficacy and safety of empagliflozin for type 2 diabetes mellitus: Meta-analysis of randomized controlled trials

Yun-Jing Zhang  1 , Shi-Liang Han  2 , Xi-Feng Sun  1 , Shu-Xiang Wang  1 , Hong-Yun Wang  1 , Xiao Liu  3 , Li Chen  4 , Ling Xia  5
Affiliations
Review

Efficacy and safety of empagliflozin for type 2 diabetes mellitus: Meta-analysis of randomized controlled trials

Yun-Jing Zhang et al. Medicine (Baltimore). 2018 Oct.

Abstract

Background: This study was designed to evaluate the efficiency and tolerability of empagliflozin (EMPA) as monotherapy or add-on to existing therapy in patients with type 2 diabetes mellitus (T2DM).

Methods: Randomized controlled trials (RCTs) comparing efficacy and safety of EMPA vs placebo or EMPA plus other antidiabetes drugs vs placebo plus other oral antidiabetes drugs (OADs) in T2DM were recruited from electronic database Pubmed, Web of Knowledge, and Cochrane Central Register of Controlled Trials (CENTRAL), supplemented by a hand search of the reference lists of selected articles. Main effect sizes were change from baseline on glycemia control, body weight, blood pressure, and complications (i.e., incidence of urinary and genital tract infections, and morbidity of hypoglycemia and hyperglycemia). Random-effects model was used to account for clinical or methodologic heterogeneity across studies.

Results: Fifteen RCTs with a total number of 7891 individuals (5374 in EMPA group and 2517 in control group) were suitable for this meta-analysis. The results demonstrated that significant improvements in glycemia control, body weight, and blood pressure were associated with EMPA application (i.e., monotherapy and add-on therapy) in patient with T2DM when compared with placebo. Meanwhile, EMPA 10 and 20 mg improved glycemia, body weight, and blood pressure control for patients with T2DM. There was no significant difference in incidence of hypoglycemia and urinary tract infections across EMPA and placebo group. Significant reduced risk of hyperglycemia was revealed in EMPA group vs placebo (risk ratio: 0.34, 95%confidence interval: 0.23-0.49, P < .00001), except in patients on background insulin therapy. However, increased risk of genital infection was noted across EMPA vs placebo (risk ratio: 2.59, 95% confidence interval: 1.80-3.71, P < .00001).

Conclusion: Our evidence supports the application of EMPA in treatment of patients with T2DM who are obesity or at risk of weight gain.

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Figures

Figure 1
Figure 1
Flow diagram of the selected studies.
Figure 2
Figure 2
Risk of bias evaluation of eligible studies.
Figure 3
Figure 3
Forest plot: relative risks on urinary tract infection (UTI) of empagliflozin (EMPA) on type 2 diabetes mellitus.
Figure 4
Figure 4
Forest plot: relative risks on genital infection of empagliflozin (EMPA) on type 2 diabetes mellitus.
Figure 5
Figure 5
Forest plot: relative risks on hyperglycemia of empagliflozin (EMPA) on type 2 diabetes mellitus.
Figure 6
Figure 6
Forest plot: relative risks on hypoglycemia of empagliflozin (EMPA) on type 2 diabetes mellitus.
Figure 7
Figure 7
Funnel plot evaluating publication bias. EMPA = empagliflozin.
See this image and copyright information in PMC

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