Background: Sotagliflozin, an inhibitor of both SGLT1 and SGLT2, is under investigation for potential cardioprotective effects in diabetic patients. Aims: This study assesses the efficacy and cardiovascular benefits of sotagliflozin in patients with type 1 or type 2 diabetes at high cardiovascular risk or with diagnosed heart failure. Methods: We systematically searched digital databases including ClinicalTrials.gov, PubMed, Google Scholar, Cochrane, Medline, and Embase, using a PICOS-based strategy and the PRISMA framework for data reporting. Randomized controlled trials comparing sotagliflozin against placebo over a minimum duration of eight weeks were analyzed using Review Manager (RevMan) 5.4.1. Results: Our meta-analysis included 7 studies with 16,315 participants with all studies comparing either 200 or 400 mg sotagliflozin to placebo. The meta analaysis revealed significant improvements in reduction the total number of cardiovascular deaths [OR= 0.70 (95% CI (0.51- 0.95)), p = 0.02]; reduction in Non-fatal MI [OR=0.76 (95% CI (0.70- 0.84)), p < 0.00001]; reduction in the incidence of hospitalizations due to HF [OR=0.54 (95% CI (0.44, 0.66)), p < 0.00001]; reduction In urgent hospitalizations [OR=0.66 (95% CI (0.53, 0.83)), p=0.0004]; improvement in LVEF>50% [ OR= 0.41 (95%CI (0.34, 0.51)), p<0.0001] and reduction in systolic blood pressure mean reduction of -0.81 (95% CI (1.36, -0.25)), p=0.005]. However there was no statistically significant reduction in all cause mortality [0.73 (95% CI (0.42, 1.26)), p=0.26] . Conclusion: Sotagliflozin significantly reduces the incidence of cardiovascular deaths, adverse events, and hospitalizations in diabetic patients at high risk of cardiovascular complications.
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