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每周一次二肽基肽酶-4 抑制剂替格列汀治疗 2 型糖尿病的安全性和疗效:一项荟萃分析。

Safety and efficacy of once weekly dipeptidyl-peptidase-4 inhibitor trelagliptin in type-2 diabetes: A meta-analysis.

机构信息

Department of Endocrinology, CEDAR Superspeciality Healthcare, New Delhi, India.

Department of Medicine, Post-Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.

出版信息

Diabetes Metab Syndr. 2022 Apr;16(4):102469. doi: 10.1016/j.dsx.2022.102469. Epub 2022 Mar 21.

Abstract

BACKGROUND & AIMS: Pooled systematic analysis of safety and efficacy data of trelagliptin in type-2 diabetes (T2DM) is lacking. We undertook this meta-analysis to address this issue.

METHODS

Electronic databases were searched for RCTs involving people with T2DM receiving trelagliptin in study arm, and placebo/active comparator in control arm. Primary outcome was to evaluate changes in HbA1c. Secondary outcomes were to evaluate alterations in pre and post-meal glucose levels, glycaemic targets, lipid parameters and adverse events.

RESULTS

From initially screened 63 articles, data from 6 RCTs involving 981 patients was analysed [3 in active control group (ACG) defined as having alogliptin, sitagliptin, linagliptin, teneligliptin, anagliptin or vildagliptin as active comparator; 2 in passive control group (PCG) defined as having placebo as controls; 1 study had both ACG and PCG]. HbA1c reduction by trelagliptin was comparable to ACG [MD 0.06% (95% CI: -0.03 - 0.16); P = 0.20; I = 0%], but superior to PCG [MD -0.54% (95% CI: -0.64 to -0.44); P < 0.01; I = 22%]. Fasting blood glucose lowering with trelagliptin was inferior to ACG [MD +6.98 mg/dl (95%CI: 2.55-11.42); P = 0.002; I = 0%], but superior to PCG [MD -6.11 mg/dl (95%CI: -12.00 to -0.23); P = 0.04; I = 54%]. Glycated albumin lowering was similar to ACG [MD 0.03% (95%CI: -0.47 - 0.53); P = 0.92; I = 0%], but superior to PCG [MD -2.31% (95% CI: -2.86 to -1.76); P < 0.01; I = 0%]. Treatment-emergent adverse events [Risk ratio (RR) 1.18 (95%CI:0.63-2.21); P = 0.59; I = 19%] and severe adverse events [RR 1.75 (95%CI: 0.90-3.40); P = 0.10; I = 0%] were comparable among groups.

CONCLUSION

Once weekly trelagliptin has good glycaemic efficacy and well tolerated in people with T2DM.

摘要

背景与目的

目前缺乏托格列净治疗 2 型糖尿病(T2DM)的安全性和疗效的汇总系统分析。我们进行了这项荟萃分析来解决这个问题。

方法

电子数据库中检索了涉及接受托格列净治疗的 T2DM 患者的 RCTs,并在对照组中使用安慰剂/活性对照。主要结局是评估 HbA1c 的变化。次要结局是评估餐前和餐后血糖水平、血糖目标、血脂参数和不良事件的变化。

结果

最初筛选出 63 篇文章,分析了 6 项 RCT 中 981 名患者的数据[3 项在活性对照组(ACG)中,定义为使用阿格列汀、西格列汀、利格列汀、替格列汀、阿那格列汀或维格列汀作为活性对照;2 项在被动对照组(PCG)中,定义为使用安慰剂作为对照;1 项研究同时具有 ACG 和 PCG]。与 ACG 相比,托格列净降低 HbA1c 的效果相当[MD 0.06%(95%CI:-0.03 至 0.16);P=0.20;I=0%],但优于 PCG[MD-0.54%(95%CI:-0.64 至-0.44);P<0.01;I=22%]。托格列净降低空腹血糖的效果不如 ACG[MD+6.98mg/dl(95%CI:2.55-11.42);P=0.002;I=0%],但优于 PCG[MD-6.11mg/dl(95%CI:-12.00 至-0.23);P=0.04;I=54%]。糖化白蛋白降低的效果与 ACG 相似[MD 0.03%(95%CI:-0.47 至 0.53);P=0.92;I=0%],但优于 PCG[MD-2.31%(95%CI:-2.86 至-1.76);P<0.01;I=0%]。治疗相关不良事件[风险比(RR)1.18(95%CI:0.63-2.21);P=0.59;I=19%]和严重不良事件[RR 1.75(95%CI:0.90-3.40);P=0.10;I=0%]在各组之间相当。

结论

每周一次的托格列净在 T2DM 患者中具有良好的降糖疗效,且耐受性良好。

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