Clinical Focus ›› 2024, Vol. 39 ›› Issue (7): 581-592.doi: 10.3969/j.issn.1004-583X.2024.07.001

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Efficacy and safety of sotagliflozin in the treatment of type 2 diabetes mellitus: A meta-analysis

Yue Jianghong1, Wang Heng2, Cai Gang3a, Zhang Xuanming3a, Peng Xi3b()   

  1. 1. Department of Pharmacy, the 7th Division Hospital of Xinjiang Production and Construction Corps, Kuitun 833200, China
    2. College of Pharmacy, Shihezi University, Shihezi 832003, China
    3a. Departmentof 'Traditional Chinese Medicine; b. Department of Pharmacy, the First A ffliated Hospital of Shihezi University, Xinjiang Shihezi 832008,China
  • Received:2024-01-08 Online:2024-07-20 Published:2024-08-02
  • Contact: Peng Xi E-mail:pxshz@163.com

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Abstract:

Objective To evaluate the efficacy and safety of sotagliflozin in the treatment of type 2 diabetes mellitus (T2DM). Methods Randomized controlled trials (RCTs) involving sotagliflozin versus placebo (or other oral hypoglycemic agents) in the treatment of T2DM pulished before October 31, 2023 were retrieved in PubMed, Embase, Web of science, Medline, Cochrane Library, the North American Clinical Trial Register, CNKI, Wanfang, VIP, SinoMed and other databases. The extracted Valid data were performed for quality evaluation, and a meta-analysis was conducted using RevMan 5.3 software. Results Fourteen RCTs representing 16, 959 patients were included. The results of meta-analysis showed: In terms of efficacy, compared with the control group, sotagliflozin group presented significantly decreased glycated hemoglobin (HbA1c, MD=-0.45, 95%CI[-0.58, -0.33]; P<0.01) and fasting blood glucose (FBG, MD=-0.66, 95%CI[-1.01, -0.31]; P=0.0002) and 2-h postprandial glucose (2hPG, MD=-1.01, 95%CI[-1.58, -0.44]; P=0.0005), and improved compliance rate of HbA1c <7% (RR=1.88, 95%CI[1.64, 2.15], P<0.01). Compared with control group, sotagliflozin group had decreased systolic blood pressure (SBP, MD=-2.13, 95%CI[-2.81, -1.45], P<0.01) and body mass (BM, MD=-1.40, 95%CI[-1.63, -1.17], P<0.01), but there was no statistical significance in reducing diastolic blood pressure (DBP). In terms of safety, the incidence of hypoglycemic events was similar between the sotagliflozin group and the control group (RR=1.00, 95%CI[0.92, 1.09], P=0.97). However, the incidence of adverse reactions was significantly lower in sotagliflozin group (RR=0.92, 95%CI [0.88, 0.96], P<0.01). Subgroup analysis according to different doses of sotagliflozin showed that compared with the control group, sotagliflozin 200 mg and 400 mg groups could significantly reduce the HbA1c and FBG, improve the compliance rate of HbA1c<7%, and reduce SBP, BM and other indexes (P<0.05), and without increasing the risk of hypoglycemia events (P>0.05). Conclusion Sotagliflozin can significantly reduce HbA1c, FBG, 2hPG, SBP, and BM in T2DM patients without increasing the risk of hypoglycemia or the incidence of adverse reactions.

Key words: diabetes mellitus, type 2, sotagliflozin, meta-analysis, efficacy, safety

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