Diabetes, obesity & metabolism · 2020
Evaluation of the safety of sodium-glucose co-transporter-2 inhibitors for treating patients with type 1 diabetes.
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Wang Weihao, Zhang Lina, Pei Xiaobei, Pan Qi, Guo Lixin
Аннотация
AIM: To conduct an overall safety assessment of sodium-glucose co-transporter-2 (SGLT-2) inhibitors used for the treatment of patients with type 1 diabetes (T1D), including ketoacidosis, genital infection, volume depletion, liver and kidney injury events, cardiovascular events, diarrhea and severe hypoglycaemia.
MATERIALS AND METHODS: We searched three databases (Pubmed, Embase and the Cochrane Library) for randomized controlled trials that treated T1D by using SGLT-2 inhibitors from 2000 to 5 March 2020.
RESULTS: Of the 1653 articles identified that fit our search criteria, 22 studies included qualitative-based results, eight of which were randomized clinical trials that included quantitative-based results. Compared with the control group, the SGLT-2 inhibitors treatment group was found to have had an increased incidence of ketoacidosis (P < .00001, OR 4.34, 95% CI [2.37, 7.96], I2 = 18%), events leading to discontinuation (P < .0001, OR 1.76, 95% CI [1.34, 2.31], I2 = 0%), genital infection (P < .00001, OR 3.64, 95% CI [2.82, 4.70], I2 = 0%), volume depletion (P = .006, OR 2.10, 95% CI [1.23, 3.59], I2 = 4%) and diarrhoea (P = .008, OR 1.64, 95% CI [1.14, 2.36], I2 = 0%). However, according to subgroup analysis, the risk of diarrhoea was dose-related. The incidence of urinary tract infection, cardiovascular events, renal events, liver injury and fracture was not significantly different for the treatment group compared with the control group.
CONCLUSIONS: Despite showing some promise as a treatment approach, the application of SGLT-2 inhibitors for patients with T1D should be considered with caution.
MATERIALS AND METHODS: We searched three databases (Pubmed, Embase and the Cochrane Library) for randomized controlled trials that treated T1D by using SGLT-2 inhibitors from 2000 to 5 March 2020.
RESULTS: Of the 1653 articles identified that fit our search criteria, 22 studies included qualitative-based results, eight of which were randomized clinical trials that included quantitative-based results. Compared with the control group, the SGLT-2 inhibitors treatment group was found to have had an increased incidence of ketoacidosis (P < .00001, OR 4.34, 95% CI [2.37, 7.96], I2 = 18%), events leading to discontinuation (P < .0001, OR 1.76, 95% CI [1.34, 2.31], I2 = 0%), genital infection (P < .00001, OR 3.64, 95% CI [2.82, 4.70], I2 = 0%), volume depletion (P = .006, OR 2.10, 95% CI [1.23, 3.59], I2 = 4%) and diarrhoea (P = .008, OR 1.64, 95% CI [1.14, 2.36], I2 = 0%). However, according to subgroup analysis, the risk of diarrhoea was dose-related. The incidence of urinary tract infection, cardiovascular events, renal events, liver injury and fracture was not significantly different for the treatment group compared with the control group.
CONCLUSIONS: Despite showing some promise as a treatment approach, the application of SGLT-2 inhibitors for patients with T1D should be considered with caution.