Nayudu Greeshma S S, Benny Binit M, Thomas Grace, Khan Maria A, Basutkar Roopa S
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, The Nilgiris, Tamil Nadu, India.
Department of Pharmacy Practice, Nitte (Deemed to be University), NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Mangalore, Karnataka, India.
Indian J Community Med. 2024 Mar-Apr;49(2):269-278. doi: 10.4103/ijcm.ijcm_210_23. Epub 2024 Mar 7.
Evidence for reducing cardiovascular and renal events with sotagliflozin is uncertain among type 2 diabetes mellitus (T2DM) patients. To gather more evidence, this meta-analysis assesses the beneficial effects of sotagliflozin, a dual sodium-glucose cotransporter 1 and 2 inhibitor, in reducing the cardiovascular and renal events in diabetic patients with or without chronic kidney disease (CKD). Scopus, Google Scholar, Cochrane Central Register of Controlled Trials (CENTRAL), and PubMed were the databases used to search. The studies published from January 1, 2018, to January 30, 2022, were considered. The eligibility of studies was assessed independently. The data were collected in a modified Cochrane data extraction form. The included studies' quality was assessed with the Cochrane risk-of-bias tool. The quality of evidence for renal and cardiovascular outcomes was evaluated using GRADEpro software. The number of events of urgent visits to the hospital and requiring hospitalization was reduced (RR: 0.73; 95% CI: 0.69, 0.78; value <0.00001). The mortality rate because of cardiovascular events was decreased with sotagliflozin (RR: 0.73; 95% CI: 0.67, 0.80; value <0.00001). Patients taking sotagliflozin had a drastic decline in the number of deaths due to stroke and non-fatal myocardial infarction. Yet, there is no difference between the groups in terms of changes in mortality due to other causes or the glomerular filtration rate (GFR). Sotagliflozin demonstrated effectiveness in reducing the mortality rate related to heart failure and cardiovascular events when the dose was increased from 200 mg to 400 mg. Despite this, evidence is still needed to prove the renal protective action.
在2型糖尿病（T2DM）患者中，索格列净降低心血管和肾脏事件的证据尚不明确。为了收集更多证据，本荟萃分析评估了双钠-葡萄糖协同转运蛋白1和2抑制剂索格列净在降低患有或不患有慢性肾脏病（CKD）的糖尿病患者心血管和肾脏事件方面的有益作用。使用Scopus、谷歌学术、Cochrane对照试验中央注册库（CENTRAL）和PubMed作为检索数据库。纳入了2018年1月1日至2022年1月30日发表的研究。独立评估研究的纳入资格。采用改良的Cochrane数据提取表收集数据。使用Cochrane偏倚风险工具评估纳入研究的质量。使用GRADEpro软件评估肾脏和心血管结局的证据质量。紧急就医和需要住院治疗的事件数量减少（相对风险：0.73；95%置信区间：0.69，0.78；P值<0.00001）。索格列净降低了心血管事件导致的死亡率（相对风险：0.73；95%置信区间：0.67，0.80；P值<0.00001）。服用索格列净的患者因中风和非致命性心肌梗死导致的死亡人数大幅下降。然而，两组在其他原因导致的死亡率变化或肾小球滤过率（GFR）方面没有差异。当索格列净剂量从200mg增加到400mg时，其在降低与心力衰竭和心血管事件相关的死亡率方面显示出有效性。尽管如此，仍需要证据来证明其肾脏保护作用。
