The following is a summary of “Safety and efficacy of sotagliflozin in patients with type II diabetes mellitus and chronic kidney disease: a meta-analysis of randomized controlled trials,” published in the December 2023 issue of Nephrology by Borges et al.
Despite promising blood sugar control in type 2 diabetes mellitus (T2DM), sotagliflozin’s safety and effectiveness for patients with added chronic kidney disease (CKD) remain unclear. Researchers conducted a retrospective study to dissect the current landscape of sotagliflozin’s safety and efficacy in T2DM patients with CKD.
They searched PubMed, Embase, Cochrane, and Web of Science for RCTs assessing Sotagliflozin’s safety and efficacy in T2DM and CKD versus placebo. Statistical analysis utilized RevMan 5.4, with heterogeneity estimated using I2 statistics. Study protocol was registered in the PROSPERO registry (CRD42023449631).
The results showed 11,648 patients over 15.7 ± 5.9 months, sotagliflozin showed a notable decrease in HbA1C (MD −0.33%; 95% CI [−0.54, −0.11]; P=0.003; I2 = 100%) and weight (MD −1.01 kg; 95% CI [−1.17, −0.86]; P<0.00001; I2 = 96%) compared with placebo. All-cause mortality (RR 0.98; 95% CI [0.81, 1.20]; P=0.87; I2 = 0%) and major adverse cardiovascular events (RR 0.70; 95% CI [0.40, 1.21]; P=0.20; I2 = 39%) showed no changes. However, sotagliflozin led to a notable reduction in estimated glomerular filtration rate (MD − 0.95; 95% CI [−1.32, −0.58]; P<0.00001; I2 = 98%) and increased occurrences of genital mycotic infections (RR 2.73; 95% CI [1.96, 3.79]; P<0.00001; I2 = 0%), diarrhea (RR 1.42; 95% CI [1.24. 1.63]; P<0.00001; I2 = 0%), and volume depletion (RR 1.31; 95% CI [1.11, 1.56]; P=0.002; I2 = 0%).
They concluded that T2DM plus CKD sotagliflozin improved sugar/weight but harmed kidneys and raised side effects.
Source: springer.com/article/10.1007/s40620-023-01818-2
