Sotagliflozin for patients with type 2 diabetes: A systematic review and meta‐analysis

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2022-01, Vol.24 (1), p.106-114
• Main Authors: Avgerinos, Ioannis, Karagiannis, Thomas, Kakotrichi, Panagiota, Michailidis, Theodoros, Liakos, Aris, Matthews, David R., Tsapas, Apostolos, Bekiari, Eleni
• Format: Article
• Language: English
• Subjects: Adverse events; Antidiabetics; Blood pressure; Body weight; Cardiovascular diseases; Cerebral infarction; Clinical trials; Congestive heart failure; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetic ketoacidosis; Diarrhea; Glucose transporter; glycaemic control; Glycosides - adverse effects; Heart attacks; Heart failure; Humans; Hypoglycemia; Hypoglycemic Agents - adverse effects; Ketoacidosis; macrovascular disease; Meta-analysis; Mortality; Myocardial infarction; Patients; Placebos; Safety; SGLT2 inhibitor; Sodium-Glucose Transporter 2 Inhibitors - adverse effects; type 2 diabetes
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14555

Aim To assess the efficacy and safety of sotagliflozin in patients with type 2 diabetes. Methods We searched Medline, Embase, the Cochrane Library, and grey literature sources up to August 2021 for randomized controlled trials (RCTs) that compared sotagliflozin with placebo or other antidiabetic agents in patients with type 2 diabetes. Our primary outcome was change in HbA1c from baseline. We additionally assessed three secondary efficacy and 15 safety outcomes. We synthesized data using weighted mean differences (WMDs) and odds ratios (ORs), along with 95% confidence intervals (CIs). Results We included 11 RCTs comprising 16 411 subjects in the meta‐analysis. Compared with placebo, sotagliflozin reduced HbA1c (WMD −0.42%, 95% CI −0.56 to −0.29), body weight (WMD −1.33 kg, 95% CI −1.57 to −1.09), and systolic blood pressure (WMD −2.44 mmHg, 95% CI −2.81 to −2.07). No difference was evident against other active comparators. Sotagliflozin reduced myocardial infarction (OR 0.72, 95% CI 0.54 to 0.97) and heart failure (OR 0.68, 95% CI 0.58 to 0.79) compared with placebo, and had a neutral effect on all‐cause mortality, cardiovascular mortality, and stroke. Treatment with sotagliflozin was safe regarding the incidence of serious adverse events, hypoglycaemia, and diabetic ketoacidosis. Nevertheless, it was associated with an increased incidence of diarrhoea, genital infections, and volume depletion events. Conclusions Sotagliflozin reduces blood glucose, body weight, and systolic blood pressure, and demonstrates a beneficial effect on heart failure and myocardial infarction. Its overall safety profile is comparable with other sodium‐glucose co‐transporter‐2 inhibitors.