Bekiari Eleni, Rizava Chrysoula, Athanasiadou Eleni, Papatheodorou Konstantinos, Liakos Aris, Karagiannis Thomas, Mainou Maria, Rika Maria, Boura Panagiota, Tsapas Apostolos
Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University Thessaloniki, Hippokratio General Hospital, 49 Konstantinoupoleos Street, 54642, Thessaloníki, Greece.
Diabetes Centre, Second Medical Department, Aristotle University Thessaloniki, Thessaloníki, Greece.
Endocrine. 2016 Jun;52(3):458-80. doi: 10.1007/s12020-015-0841-1. Epub 2015 Dec 29.
This systematic review and meta-analysis provides an update on the efficacy and safety of vildagliptin for treatment of type 2 diabetes mellitus (T2DM). We searched MEDLINE, COCHRANE, EMBASE and the drug manufacturer's website for randomised controlled trials of vildagliptin in patients with T2DM. Sixty-nine studies (28,006 patients) were included in the meta-analysis. Compared with placebo vildagliptin reduced HbA1c (weighted mean difference WMD -0.69 %; 95 % CI -0.83 to -0.56 %; I (2) = 82 %), and it was as effective as other antidiabetic agents (WMD -0.01 %; 95 % CI -0.16 to 0.14 %; I (2) = 93 %), without increasing the risk for hypoglycemia (OR 0.83; 95 % CI 0.59 to 1.16; I (2) = 0 % vs. placebo, and OR 0.19; 95 % CI 0.15 to 0.24; I (2) = 78 % versus active comparators). However, it was associated with an increase in the incidence of arthralgia compared with other comparators (OR 1.23; 95 % CI 1.02 to 1.48; I (2) = 0 %). On the contrary, vildagliptin did not increase the incidence of pancreatitis (OR 0.97; 95 % CI 0.37 to 2.53; I (2) = 0 %), serious adverse events (OR 0.98; 95 % CI 0.88 to 1.09; I (2) = 0 %) or death (OR 1.10, 95 % CI 0.75 to 1.61; I (2) = 0 %). Finally, odds ratio (OR) for heart failure, and overall cardiovascular and cerebrovascular events was 0.77 (95 % CI 0.46 to 1.30; I (2) = 0 %) and 0.91 (95 % CI 0.73 to 1.14; I (2) = 0 %), respectively. Vildagliptin is an effective and safe therapeutic option for patients with T2DM, both as monotherapy and as add-on treatment.
本系统评价和荟萃分析提供了维格列汀治疗2型糖尿病（T2DM）疗效和安全性的最新信息。我们检索了MEDLINE、COCHRANE、EMBASE以及药品制造商网站，以查找维格列汀治疗T2DM患者的随机对照试验。荟萃分析纳入了69项研究（28006例患者）。与安慰剂相比，维格列汀可降低糖化血红蛋白（加权均值差WMD -0.69%；95%置信区间 -0.83至-0.56%；I² = 82%），且其疗效与其他抗糖尿病药物相当（WMD -0.01%；95%置信区间 -0.16至0.14%；I² = 93%），同时不会增加低血糖风险（与安慰剂相比，比值比OR 0.83；95%置信区间0.59至1.16；I² = 0%，与活性对照药相比，OR 0.19；95%置信区间0.15至0.24；I² = 78%）。然而，与其他对照药相比，维格列汀与关节痛发生率增加相关（OR 1.23；95%置信区间1.02至1.48；I² = 0%）。相反，维格列汀不会增加胰腺炎发生率（OR 0.97；95%置信区间0.37至2.53；I² = 0%）、严重不良事件发生率（OR 0.98；95%置信区间0.88至1.09；I² = 0%）或死亡率（OR 1.10，95%置信区间0.75至1.61；I² = 0%）。最后，心力衰竭以及总体心血管和脑血管事件的比值比（OR）分别为0.77（95%置信区间0.46至1.30；I² = 0%）和0.91（95%置信区间0.73至1.14；I² = 0%）。维格列汀无论是作为单药治疗还是联合治疗，都是T2DM患者有效且安全的治疗选择。
