Department of Neurology, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
J Neurol Neurosurg Psychiatry. 2018 Jan;89(1):21-27. doi: 10.1136/jnnp-2017-316361. Epub 2017 Sep 22.
Patients with cerebrovascular disease are at increased risk for cognitive dysfunction. Modification of vascular risk factors, including insulin resistance, could improve poststroke cognitive function.
In the Insulin Resistance Intervention after Stroke (IRIS) trial, patients with a recent ischaemic stroke or transient ischaemic attack (TIA) were randomised to pioglitazone (target 45 mg daily) or placebo. All patients were insulin resistant based on a Homeostasis Model Assessment-Insulin Resistance score >3.0. For this preplanned analysis of cognitive function, we examined the Modified Mini-Mental State Examination (3MS) score (maximum score, 100) during follow-up. Patients were tested at baseline and annually for up to 5 years. Longitudinal mixed model methods were used to compare changes in the 3MS over time.
Of the 3876 IRIS participants, 3398 had a 3MS score at baseline and at least once during follow-up and were included in the analysis. Median 3MS score at baseline was 97 (IQR 93-99). The average overall least squared mean 3MS score increased by 0.27 in the pioglitazone group and by 0.29 in the placebo group (mean difference between treatment groups -0.02; 95% CI -0.33 to 0.28, p=0.88).
Among insulin-resistant patients with a recent ischaemic stroke or TIA, pioglitazone did not affect cognitive function, as measured by the 3MS, over 5 years.
ClinicalTrials.gov NCT00091949; Results.
患有脑血管疾病的患者认知功能障碍的风险增加。血管危险因素的改变，包括胰岛素抵抗，可能改善中风后的认知功能。
在胰岛素抵抗干预后中风（IRIS）试验中，近期发生缺血性中风或短暂性脑缺血发作（TIA）的患者被随机分配到吡格列酮（目标剂量为 45mg/天）或安慰剂。所有患者的胰岛素抵抗均基于稳态模型评估-胰岛素抵抗评分>3.0。根据这项对认知功能的预先计划分析，我们检查了随访期间的改良简易精神状态检查（3MS）评分（最高 100 分）。患者在基线和每年进行一次测试，最长可达 5 年。使用纵向混合模型方法比较 3MS 随时间的变化。
在 3876 名 IRIS 参与者中，有 3398 名患者在基线时有 3MS 评分，并且在随访期间至少有一次，因此被纳入分析。基线时的中位数 3MS 评分为 97（IQR 93-99）。吡格列酮组的平均整体最小二乘均值 3MS 评分增加了 0.27，安慰剂组增加了 0.29（治疗组之间的平均差异为-0.02；95%CI-0.33 至 0.28，p=0.88）。
在近期发生缺血性中风或 TIA 的胰岛素抵抗患者中，吡格列酮在 5 年内未影响认知功能，3MS 测量结果为。
ClinicalTrials.gov NCT00091949；结果。
