Background: Pioglitazone may have a protective effect against cardiovascular disease risk among type 2 diabetes (T2D) patients, but evidence from China is lacking. This study investigated the association using electronic health records (EHR) data from a Chinese cohort of T2D patients.
Methods: All T2D patients from the First Affiliated Hospital of Nanjing Medical University who were prescribed at least one oral antidiabetic drug and were aged ≥18 years between 1 July 2005 and 30 June 2017 were eligible for inclusion (n = 71 783). Pioglitazone use was determined in 6-month study intervals, with outcome events of myocardial infarction (MI), ischemic stroke, and heart failure. Poisson regression was used to estimate adjusted rate ratios (RRs) with 95% confidence intervals (CIs).
Results: In multivariable analysis adjusted for potential confounders, pioglitazone use, compared with no use, was associated with a significant 39% decreased risk of MI (RR = 0.61; 95% CI = 0.42-0.90; P = 0.012). Pioglitazone use was also associated with a non-significant reduction in risk of heart failure or stroke. When MI, heart failure, and stroke were combined as a composite outcome, pioglitazone use was associated with a 30% decrease in risk (RR = 0.70; 95% CI = 0.56-0.88; P = 0.002).
Conclusions: This study demonstrates that applying informatics tools to a large EHR database could be a good way to efficiently conduct clinical observational research. In addition, the findings validated the favorable effect of pioglitazone on the risk of MI among T2D patients in China, with the use of pioglitazone decreasing the risk of MI among those with T2D.
背景: 吡格列酮可能对2型糖尿病患者的心血管疾病风险具有保护作用，但一直缺乏来自中国的研究证据。本研究利用中国的2型糖尿病患者的电子病历记录数据中来分析这种关联。 方法: 将南京医科大学第一附属医院在2005年7月1日至2017年6月30日期间，开出的至少一种口服抗糖尿病药物且年龄≧18岁的所有2型糖尿病患者纳入研究队列(n = 71783)。以6个月为研究间隔，确定患者在该研究周期是否使用吡格列酮，观察的终点事件包括心肌梗死、缺血性中风和心力衰竭。泊松回归用于估计校正后的比率(RR)和95%置信区间(CI)。 结果: 在校正混杂因素的多变量分析中，与未使用吡格列酮相比，使用吡格列酮组心肌梗死风险显著降低39%(RR = 0.61；95% CI = 0.42-0.90；P = 0.012)。吡格列酮的使用与心力衰竭或中风风险降低没有显著相关性。当心肌梗死、心力衰竭和卒中综合作为复合结局时，吡格列酮的使用使风险降低30%(RR = 0.70；95% CI = 0.56-0.88；P = 0.002)。 结论: 本研究表明，将信息学工具应用于大型EHR数据库可能是有效开展临床观察研究的好方法。此外，该研究结果验证了吡格列酮对中国2型糖尿病患者心肌梗死风险的有利影响，使用吡格列酮降低了2型糖尿病患者心肌梗死的风险。.
Keywords: 2型糖尿病; Chinese population; Poisson regression; cardiovascular disease; pioglitazone; type 2 diabetes; 中国人群; 吡格列酮; 心血管疾病; 泊松回归.
© 2018 The Authors. Journal of Diabetes published by John Wiley & Sons Australia, Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.