Asche C V, McAdam-Marx C, Shane-McWhorter L, Sheng X, Plauschinat C A
Outcomes Research Center, Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City, UT 84108, USA.
Diabetes Obes Metab. 2008 Aug;10(8):638-45. doi: 10.1111/j.1463-1326.2007.00758.x. Epub 2007 Jul 21.
To quantify adverse events (AEs) associated with the use of metformin (MET), sulphonylureas (SUs) and thiazolidinediones (TZDs) in a usual care setting, and to assess the relationship of AEs to treatment patterns and glycaemic response in patients with type 2 diabetes.
An electronic medical record database was used to identify patients with type 2 diabetes age >or=18 years from 1996 to 2005. Patients naïve to oral antidiabetic therapy were followed for 395 days postinitiation of MET, SU or TZD treatment. AEs related to study drugs were evaluated during the follow-up period. Baseline and follow-up A1C levels were compared by drug regimen. Associations between the change in A1C, drug regimen changes and AEs were evaluated.
A total of 14,512 patients (mean age 60.8 years, 52.9% female) were identified. During the follow-up period, 12.7% of patients experienced an AE (8.6% MET, 15.9% SU and 19.8% TZD patients). SU and TZD patients were more likely to experience an AE than MET (p < 0.001) patients. AEs did not significantly influence A1C outcomes, although MET and SU patients experiencing an AE were more likely to add-on therapy (odds ratio (OR) = 1.34 and OR = 1.37, respectively; p < 0.05) than those without an AE. MET patients with AEs were more likely to switch therapy (OR = 1.91; p < 0.05) than those without an AE.
The occurrence of AEs did not significantly impact glycaemic response to therapy. However, AEs may lead to greater treatment switches for patients receiving MET and add-on therapy for MET-treated and SU-treated patients.
在常规治疗环境中量化与使用二甲双胍（MET）、磺脲类药物（SUs）和噻唑烷二酮类药物（TZDs）相关的不良事件（AEs），并评估2型糖尿病患者中不良事件与治疗模式及血糖反应的关系。
使用电子病历数据库识别1996年至2005年年龄≥18岁的2型糖尿病患者。初治口服抗糖尿病治疗的患者在开始MET、SU或TZD治疗后随访395天。在随访期间评估与研究药物相关的不良事件。通过药物治疗方案比较基线和随访时的糖化血红蛋白（A1C）水平。评估A1C变化、药物治疗方案变化与不良事件之间的关联。
共识别出14512例患者（平均年龄60.8岁，52.9%为女性）。在随访期间，12.7%的患者发生了不良事件（MET患者为8.6%，SU患者为15.9%，TZD患者为19.8%）。SU和TZD患者比MET患者更易发生不良事件（p<0.001）。不良事件对A1C结果无显著影响，尽管发生不良事件的MET和SU患者比未发生不良事件的患者更有可能加用治疗（比值比（OR）分别为1.34和1.37；p<0.05）。发生不良事件的MET患者比未发生不良事件的患者更有可能更换治疗方案（OR = 1.91；p<0.05）。
不良事件的发生对治疗的血糖反应无显著影响。然而，不良事件可能导致接受MET治疗的患者更换治疗方案的可能性增加，以及接受MET治疗和SU治疗的患者加用治疗。
