Bundhun Pravesh Kumar, Janoo Girish, Teeluck Abhishek Rishikesh, Huang Feng
Institute of Cardiovascular Diseases, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, People's Republic of China.
Guangxi Medical University, Nanning, Guangxi, 530027, People's Republic of China.
BMC Pharmacol Toxicol. 2017 Oct 23;18(1):66. doi: 10.1186/s40360-017-0175-0.
Vildagliptin and pioglitazone/rosiglitazone are emerging Oral Hypoglycemic Agents (OHAs) which are used to treat patients suffering from Type 2 Diabetes Mellitus (T2DM). In this analysis, we aimed to systematically compare the adverse drug events which were observed with the use of vildagliptin versus pioglitazone or rosiglitazone respectively.
Online databases were searched for studies comparing vildagliptin with pioglitazone/rosiglitazone. Adverse drug events were considered as the clinical endpoints in this analysis. We calculated Odds Ratios (OR) with 95% Confidence Intervals (CIs) using the RevMan 5.3 software. All the authors had full access to the data which were used and approved the final version of the manuscript.
A total number of 2396 patients were analyzed (1486 and 910 patients were treated with vildagliptin and pioglitazone/rosiglitazone respectively). Vildagliptin and pioglitazone/rosiglitazone were both associated with similar overall adverse drug events (OR: 1.00, 95% CI: 0.81-1.24; P = 1.00). Headache (OR: 0.88, 95% CI: 0.60-1.27; P = 0.49) and upper respiratory tract infection (OR: 0.95, 95% CI: 0.71-1.27; P = 0.75) were similarly observed. However, dizziness was significantly lower with pioglitazone/rosiglitazone (OR: 0.63, 95% CI: 0.43-0.92; P = 0.02). Back pain, diarrhea and nausea were insignificantly lower with pioglitazone/rosiglitazone (OR: 0.81, 95% CI: 0.49-1.33; P = 0.40), (OR: 0.83, 95% CI: 0.48-1.44; P = 0.52) and (OR: 0.52, 95% CI: 0.25-1.05; P = 0.07) respectively, whereas peripheral edema and weight gain were insignificantly higher (OR: 1.21, 95% CI: 0.56-2.62; P = 0.63) and (OR: 2.29, 95% CI: 0.51-10.34; P = 0.28) respectively. Nevertheless, when pioglitazone and rosiglitazone were separately compared with vildagliptin, peripheral edema and weight gain were significantly higher with rosiglitazone (OR: 2.36, 95% CI: 1.40-3.99; P = 0.001) and (OR: 5.20, 95% CI: 2.47-10.92; P = 0.0001) respectively.
Both vildagliptin and pioglitazone/rosiglitazone are acceptable for the treatment of patients with T2DM on the basis that they are not significantly different in terms of overall adverse drug events. However, weight gain and peripheral edema would have to be re-assessed in further larger randomized controlled trials.
维格列汀和吡格列酮/罗格列酮是新型口服降糖药（OHAs），用于治疗2型糖尿病（T2DM）患者。在本分析中，我们旨在系统比较使用维格列汀与分别使用吡格列酮或罗格列酮时观察到的药物不良事件。
检索在线数据库，查找比较维格列汀与吡格列酮/罗格列酮的研究。本分析将药物不良事件视为临床终点。我们使用RevMan 5.3软件计算比值比（OR）及95%置信区间（CI）。所有作者均可全面获取所使用的数据，并批准了稿件的最终版本。
共分析了2396例患者（分别有1486例和910例患者接受维格列汀和吡格列酮/罗格列酮治疗）。维格列汀和吡格列酮/罗格列酮的总体药物不良事件相似（OR：1.00，95%CI：0.81 - 1.24；P = 1.00）。类似地观察到头痛（OR：0.88，95%CI：0.60 - 1.27；P = 0.49）和上呼吸道感染（OR：0.95，95%CI：0.71 - 1.27；P = 0.75）。然而，吡格列酮/罗格列酮导致的头晕显著更低（OR：0.63，95%CI：0.43 - 0.92；P = 0.02）。吡格列酮/罗格列酮导致的背痛、腹泻和恶心略低（OR分别为：0.81，95%CI：0.49 - 1.33；P = 0.40），（OR：0.83，95%CI：0.48 - 1.44；P = 0.52）和（OR：0.52，95%CI：0.25 - 1.05；P = 0.07），而外周水肿和体重增加略高（OR分别为：1.21，95%CI：0.56 - 2.62；P = 0.63）和（OR：2.29，95%CI：0.51 - 10.34；P = 0.28）。然而，当分别将吡格列酮和罗格列酮与维格列汀比较时，罗格列酮导致的外周水肿和体重增加显著更高（OR分别为：2.36，95%CI：1.40 - 3.99；P = 0.001）和（OR：5.20，95%CI：2.47 - 10.92；P = 0.0001）。
基于维格列汀和吡格列酮/罗格列酮在总体药物不良事件方面无显著差异，二者均可用于治疗T2DM患者。然而，体重增加和外周水肿需要在进一步更大规模的随机对照试验中重新评估。
