新型二肽基肽酶-4抑制剂依格列净治疗2型糖尿病的疗效与安全性：一项荟萃分析
Efficacy and Safety of Novel Dipeptidyl-Peptidase-4 Inhibitor Evogliptin in the Management of Type 2 Diabetes Mellitus: A Meta-Analysis.
作者信息
Dutta Deep, Bhattacharya Saptarshi, Krishnamurthy Aishwarya, Sharma Lokesh Kumar, Sharma Meha
机构信息
Department of Endocrinology, Center for Endocrinology, Diabetes, Arthritis and Rheumatism (CEDAR) Super-speciality Clinics, Dwarka, India.
Department of Endocrinology, Max Superspeciality Hospital, Patparganj, India.
出版信息
Indian J Endocrinol Metab. 2020 Sep-Oct;24(5):434-445. doi: 10.4103/ijem.IJEM_418_20. Epub 2020 Nov 9.
AIMS
No meta-analysis is available which has summarized and holistically analyzed the efficacy and safety of evogliptin. We undertook this meta-analysis to address this gap in knowledge.
METHODS
Electronic databases were searched for RCTs involving diabetes patients receiving evogliptin in intervention arm and placebo/active comparator in control arm. Primary outcome was to evaluate changes in HbA1c. Secondary outcomes were to evaluate alterations in fasting glucose, postprandial glucose, lipids, insulin resistance, patients achieving glycemic targets of HbA1c <7% and <6.5%, and adverse events.
RESULTS
From initially screened 57 articles, data from six RCTs involving 887 patients was analyzed [three having sitagliptin/linagliptin as active comparator; three having placebo in control group]. Evogliptin was noninferior to sitagliptin/linagliptin regarding HbA1c reduction at 12 weeks [mean difference (MD) -0.06%; 95%CI: -0.23-0.11%; = 0.48] and 24 weeks (MD 0.04%; 95%CI: -0.11-0.19%; = 0.60) follow-up. Evogliptin was superior to placebo regarding HbA1c reduction at 12-weeks (MD -0.57%; 95%CI: -0.62- -0.52%; < 0.001) and 24 weeks (MD -0.28%; 95%CI: -0.47 - -0.09%; = 0.004). Evogliptin was noninferior to sitagliptin/linagliptin regarding patients achieving HbA1c <7% and <6.5% at 12 weeks and 24 weeks follow-up. Total adverse events [Risk ratio (RR) 0.98; 95% CI: 0.72-1.32; = 0.89] and severe adverse events (RR 0.65; 95% CI: 0.25-1.67; = 0.37) were not significantly different among groups. Patients receiving evogliptin did not have increased symptomatic (RR 0.46; 95% CI: 0.10-2.16; = 0.32) and asymptomatic (RR 1.09; 95% CI: 0.61-1.97; = 0.77) hypoglycaemia.
CONCLUSION
Evogliptin is well tolerated and has good glycemic efficacy over 6 months use for T2DM management.
目的
目前尚无对依格列净的疗效和安全性进行总结及全面分析的荟萃分析。我们开展此项荟萃分析以填补这一知识空白。
方法
通过电子数据库检索涉及糖尿病患者的随机对照试验，干预组接受依格列净，对照组接受安慰剂或活性对照药。主要结局是评估糖化血红蛋白（HbA1c）的变化。次要结局是评估空腹血糖、餐后血糖、血脂、胰岛素抵抗、达到HbA1c<7%和<6.5%血糖目标的患者以及不良事件的变化。
结果
从最初筛选的57篇文章中，分析了6项随机对照试验中887例患者的数据[3项试验以西格列汀/利格列汀作为活性对照；3项试验对照组为安慰剂]。在12周[平均差值（MD）-0.06%；95%置信区间（CI）：-0.23 - 0.11%；P = 0.48]和24周（MD 0.04%；95%CI：-0.11 - 0.19%；P = 0.60）随访时，依格列净在降低HbA1c方面不劣于西格列汀/利格列汀。在12周和24周随访时，依格列净在降低HbA1c方面优于安慰剂（12周时MD -0.57%；95%CI：-0.62 - -0.52%；P < 0.001；24周时MD -0.28%；95%CI：-0.47 - -0.09%；P = 0.004）。在12周和24周随访时，在达到HbA1c<7%和<6.5%的患者方面，依格列净不劣于西格列汀/利格列汀。各组间总不良事件[风险比（RR）0.98；95%CI：0.72 - 1.32；P = 0.89]和严重不良事件（RR 0.65；95%CI：0.25 - 1.67；P = 0.37）无显著差异。接受依格列净的患者出现症状性低血糖（RR 0.46；95%CI：0.10 - 2.16；P = 0.32）和无症状性低血糖（RR 1.09；95%CI：0.61 - 1.97；P = 0.77）的情况未增加。
结论
依格列净耐受性良好，在用于2型糖尿病管理的6个月使用期内具有良好的血糖疗效。
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