亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials

医学 内科学 安慰剂 科克伦图书馆 糖尿病 不利影响 随机对照试验 餐后 临床试验 2型糖尿病 1型糖尿病 荟萃分析 梅德林 胃肠病学 置信区间 相对风险 胰岛素 内分泌学 替代医学 病理 政治学 法学
作者
Giovanni Musso,Roberto Gambino,Maurizio Cassader,Elena Paschetta
出处
期刊:BMJ [BMJ]
卷期号:: l1328-l1328 被引量:88
标识
DOI:10.1136/bmj.l1328
摘要

Abstract Objective To assess the efficacy and safety of dual sodium glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin in type 1 diabetes mellitus. Design Meta-analysis of randomised controlled trials. Data sources Medline; Cochrane Library; Embase; international meeting abstracts; international and national clinical trial registries; and websites of US, European, and Japanese regulatory authorities, up to 10 January 2019. Eligibility criteria for selecting studies Randomised controlled trials evaluating the effect of sotagliflozin versus active comparators or placebo on glycaemic and non-glycaemic outcomes and on adverse events in type 1 diabetes in participants older than 18. Three reviewers extracted data for study characteristics, outcomes of interest, and risk of bias and summarised strength of evidence using the grading of recommendations assessment, development, and evaluation approach. Main outcomes were pooled using random effects models. Results Of 739 records identified, six randomised placebo controlled trials (n=3238, duration 4-52 weeks) were included. Sotagliflozin reduced levels of glycated haemoglobin (HbA1c; weighted mean difference −0.34% (95% confidence interval −0.41% to −0.27%), P<0.001); fasting plasma glucose (−16.98 mg/dL, −22.1 to −11.9; 1 mg/dL=0.0555 mmol/L) and two hour-postprandial plasma glucose (−39.2 mg/dL, −50.4 to −28.1); and daily total, basal, and bolus insulin dose (−8.99%, −10.93% to −7.05%; −8.03%, −10.14% to −5.93%; −9.14%, −12.17% to −6.12%; respectively). Sotagliflozin improved time in range (weighted mean difference 9.73%, 6.66% to 12.81%) and other continuous glucose monitoring parameters, and reduced body weight (−3.54%, −3.98% to −3.09%), systolic blood pressure (−3.85 mm Hg, −4.76 to −2.93), and albuminuria (albumin:creatinine ratio −14.57 mg/g, −26.87 to −2.28). Sotagliflozin reduced hypoglycaemia (weighted mean difference −9.09 events per patient year, −13.82 to −4.36) and severe hypoglycaemia (relative risk 0.69, 0.49 to 0.98). However, the drug increased the risk of ketoacidosis (relative risk 3.93, 1.94 to 7.96), genital tract infections (3.12, 2.14 to 4.54), diarrhoea (1.50, 1.08 to 2.10), and volume depletion events (2.19, 1.10 to 4.36). Initial HbA1c and basal insulin dose adjustment were associated with the risk of diabetic ketoacidosis. A sotagliflozin dose of 400 mg/day was associated with a greater improvement in most glycaemic and non-glycaemic outcomes than the 200 mg/day dose, without increasing the risk of adverse events. The quality of evidence was high to moderate for most outcomes, but low for major adverse cardiovascular events and all cause death. The relatively short duration of trials prevented assessment of long term outcomes. Conclusions In type 1 diabetes, sotagliflozin improves glycaemic and non-glycaemic outcomes and reduces hypoglycaemia rate and severe hypoglycaemia. The risk of diabetic ketoacidosis could be minimised by appropriate patient selection and down-titration of the basal insulin dose.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
3秒前
3秒前
xdy完成签到 ,获得积分10
5秒前
开朗满天发布了新的文献求助10
7秒前
牛牛完成签到 ,获得积分10
7秒前
落寞平萱发布了新的文献求助10
7秒前
丸子完成签到 ,获得积分10
7秒前
andrele发布了新的文献求助30
8秒前
8秒前
lan完成签到,获得积分20
11秒前
lan发布了新的文献求助10
14秒前
yangzai完成签到 ,获得积分10
14秒前
Charles完成签到,获得积分10
18秒前
19秒前
21秒前
23秒前
礼岁岁完成签到 ,获得积分10
23秒前
ggg完成签到 ,获得积分10
25秒前
整齐海秋发布了新的文献求助10
26秒前
27秒前
jyy应助Ruri采纳,获得10
30秒前
32秒前
andrele完成签到,获得积分10
36秒前
柠栀发布了新的文献求助10
39秒前
40秒前
小彤完成签到 ,获得积分10
42秒前
10 g发布了新的文献求助10
47秒前
52秒前
科目三应助rrrred采纳,获得10
59秒前
顾矜应助小程同学采纳,获得10
1分钟前
量子星尘发布了新的文献求助10
1分钟前
东方天奇完成签到 ,获得积分10
1分钟前
1分钟前
小程同学发布了新的文献求助10
1分钟前
1分钟前
完美世界应助南宫连虎采纳,获得10
1分钟前
1分钟前
1分钟前
呼啦呼啦完成签到 ,获得积分10
1分钟前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3976608
求助须知:如何正确求助?哪些是违规求助? 3520700
关于积分的说明 11204542
捐赠科研通 3257350
什么是DOI,文献DOI怎么找? 1798716
邀请新用户注册赠送积分活动 877881
科研通“疑难数据库(出版商)”最低求助积分说明 806613