Avgerinos Ioannis, Karagiannis Thomas, Kakotrichi Panagiota, Michailidis Theodoros, Liakos Aris, Matthews David R, Tsapas Apostolos, Bekiari Eleni
Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Diabetes Centre, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Diabetes Obes Metab. 2022 Jan;24(1):106-114. doi: 10.1111/dom.14555. Epub 2021 Oct 4.
To assess the efficacy and safety of sotagliflozin in patients with type 2 diabetes.
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).
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.
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.
评估索格列净治疗2型糖尿病患者的疗效和安全性。
我们检索了截至2021年8月的Medline、Embase、Cochrane图书馆和灰色文献来源，以查找比较索格列净与安慰剂或其他抗糖尿病药物治疗2型糖尿病患者的随机对照试验（RCT）。我们的主要结局是糖化血红蛋白（HbA1c）相对于基线的变化。我们还评估了三个次要疗效结局和15个安全性结局。我们使用加权平均差（WMD）和比值比（OR）以及95%置信区间（CI）对数据进行综合分析。
我们在荟萃分析中纳入了11项RCT，共16411名受试者。与安慰剂相比，索格列净降低了HbA1c（WMD -0.42%，95%CI -0.56至-0.29）、体重（WMD -1.33 kg，95%CI -1.57至-1.09）和收缩压（WMD -2.44 mmHg，95%CI -2.81至-2.07）。与其他活性对照药物相比无明显差异。与安慰剂相比，索格列净降低了心肌梗死（OR 0.72，95%CI 0.54至0.97）和心力衰竭（OR 0.68，95%CI 0.58至0.79）的发生率，对全因死亡率、心血管死亡率和中风有中性影响。索格列净治疗在严重不良事件、低血糖和糖尿病酮症酸中毒的发生率方面是安全的。然而，它与腹泻、生殖器感染和容量耗竭事件的发生率增加有关。
索格列净可降低血糖、体重和收缩压，并对心力衰竭和心肌梗死有有益作用。其总体安全性与其他钠-葡萄糖协同转运蛋白2抑制剂相当。
