Department of Neurology, CHA Bundang Medical Center, CHA University College of Medicine, Seongnam, Republic of Korea.
Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea.
Cardiovasc Diabetol. 2019 May 31;18(1):67. doi: 10.1186/s12933-019-0874-5.
Pioglitazone is an oral antidiabetic drug with multiple pleiotropic actions. Recent clinical trials have demonstrated that treatment with pioglitazone reduces cardiovascular risk in patients who have had an ischemic stroke. We examined the secondary preventive effects of pioglitazone in acute ischemic stroke patients with diabetes mellitus (DM) based on nationwide real-world data.
A nested case-control study was conducted with data from the National Health Insurance Service-National Sample Cohort in Korea. Study subjects were diabetic patients admitted for acute ischemic stroke (ICD-10 code; I63) between 2002 and 2013. Cases were defined as patients who suffered from composites of recurrent stroke (I60-63), myocardial infarction (I21), or all-cause mortality after ischemic stroke. Controls were selected by incidence density sampling. Three controls were matched to each case for sex, age, treatment with insulin, and oral antidiabetic medications, with the exception of pioglitazone. Medication history after ischemic stroke was obtained by accessing the prescription records. In the matched dataset, conditional logistic regression analysis was performed with adjustments for hypertension, atrial fibrillation, prior myocardial infarction, and treatment with oral antithrombotics and statins.
From the patients with acute ischemic stroke and DM, 1150 cases with primary outcomes were matched to 3450 controls. In the matched analysis, treatment with pioglitazone was significantly associated with a lower cardiovascular risk (adjusted OR [95% CI], 0.43 [0.23-0.83]).
In this nested case-control study using real-world data, treatment with pioglitazone exhibited significant cardiovascular preventive effect in diabetic patients with acute ischemic stroke.
吡格列酮是一种具有多种多效作用的口服抗糖尿病药物。最近的临床试验表明,吡格列酮治疗可降低曾发生缺血性中风的患者的心血管风险。我们根据全国真实世界数据,研究了吡格列酮在糖尿病急性缺血性中风患者中的二级预防作用。
采用韩国国家健康保险服务-国家样本队列的嵌套病例对照研究设计。研究对象为 2002 年至 2013 年期间因急性缺血性中风(ICD-10 编码:I63)住院的糖尿病患者。病例定义为发生复发性中风(I60-63)、心肌梗死(I21)或缺血性中风后全因死亡的患者。通过发生率密度抽样选择对照。除吡格列酮外,每位病例匹配 3 名对照,以性别、年龄、胰岛素治疗和口服抗糖尿病药物治疗情况进行匹配。通过查阅处方记录获取缺血性中风后的药物治疗史。在匹配数据集内,采用条件逻辑回归分析,对高血压、心房颤动、既往心肌梗死和口服抗血栓药物及他汀类药物治疗进行校正。
在患有急性缺血性中风和糖尿病的患者中,1150 例主要结局病例与 3450 例对照相匹配。在匹配分析中,吡格列酮治疗与心血管风险降低显著相关(校正比值比[95%置信区间],0.43 [0.23-0.83])。
在这项基于真实世界数据的嵌套病例对照研究中,吡格列酮治疗在急性缺血性中风的糖尿病患者中表现出显著的心血管预防作用。