JOURNAL OF SHANGHAI JIAOTONG UNIVERSITY (MEDICAL SCIENCE) ›› 2021, Vol. 41 ›› Issue (4): 473-478.doi: 10.3969/j.issn.1674-8115.2021.04.009

• Clinical research • Previous Articles     Next Articles

Effect of metformin on infection event reduction in patients with systemic lupus erythematosus:a post-hoc analysis of a Met-Lupus Trial

Shi-kai GENG1(), Le ZHANG2,3(), Hui-jing WANG1, Liang-jing LÜ3, Wei-guo WAN4, Fang-fang SUN1(), Shuang YE1()   

  1. 1.Department of Rheumatology, Renji Hospital South Campus, Shanghai Jiao Tong University School of Medicine, Shanghai 201112, China
    2.Department of Pharmacy, Renji Hospital South Campus, Shanghai Jiao Tong University School of Medicine, Shanghai 201112, China
    3.Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200001, China
    4.Department of Rheumatology, Huashan Hospital, Fudan University Shanghai Medical College, Shanghai 200041, China
  • Received:2020-05-28 Online:2021-04-28 Published:2021-05-14
  • Contact: Fang-fang SUN,Shuang YE E-mail:shikai_geng@126.com;joyce66dbl@hotmail.com;fiona_rj@163.com;ye_shuang2000@163.com
  • Supported by:
    National Key Research and Development Program of China(2016YFC0903902);Three-year Action Plan of Shanghai Shenkang Hospital Development Center(16CR1013A);Youth Program of National Natural Science Foundation of China(71804109);Shanghai Health and Family Planning Commission Scientific Research Project for Youth(20174Y0040);National Natural Science Foundation Cultivation Project for Youth of Renji Hospital South Campus, Shanghai Jiao Tong University School of Medicine(2017PYQA08)

Abstract: Objective

·To evaluate the effect of metformin on reducing infection events in the systemic lupus erythematosus (SLE) patients with moderate/low disease activity based on a multicenter, randomized, double-blind, placebo-controlled clinical study (Met-Lupus Trial).

Methods

·The 140 participants in the Met-Lupus Trial were randomly divided into the metformin group (67 cases) and the placebo group (73 cases). The metformin tablets or placebo tablets were added to their standard therapy with target dose of 1 500 mg/d, three times per day. The infection events during the 12 months' follow-up of the patients were recorded, including the types of infection events, infection duration, infection severity, and laboratory results during infection. The clinical characteristics between the patients with or without infection as well as between the infected patients treated with metformin or placebo were compared. Multivariate Logistic regression analysis was used to analyze the correlation between metformin and infection events, and survival analysis was used to compare the infection-free survival time between the metformin group and the placebo group.

Results

·By 12 months of follow-up, the exposure rate of metformin in the patients without infection (65.9%) was significantly higher than that in the patients with infection (34.7%, P=0.022), while other clinical parameters were comparable. Multivariate Logistic regression analysis suggested that the use of metformin was an independent protective factor against infection in the SLE patients (OR=0.423, P=0.033). In the infected patients, the severe infection incidence in the metformin group was numerically lower than that in the placebo group, but there was no significant difference (5.9% vs 12.5%, P=0.466). Further analysis showed that the infection duration [7.0 (6.0, 11.8) d] of the metformin group was significantly lower than that of the placebo group [10.0 (7.0, 21.8) d] (P=0.034); meanwhile, the C-reactive protein in the metformin group [2.5 (2.4, 6.4) mg/L] was also lower than that in the placebo group [4.5 (2.5, 8.9) mg/L] without significant difference (P=0.075). Survival analysis showed that infection-free survival of the metformin group was significantly longer than that of the placebo group (HR=0.527, 95%CI 0.294?0.945, P=0.036).

Conclusion

·Metformin may have a potential effect on infection event reduction in the SLE patients with moderate/low disease activity.

Key words: systemic lupus erythematosus (SLE), metformin, infection, randomized controlled study

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