Farahani Pendar, Khan Shahriar, Oatway Mark, Dziarmaga Alison
J Popul Ther Clin Pharmacol. 2015;22(3):e228-36. Epub 2015 Nov 11.
A growing body of evidence generated from observational studies and meta-analyses has begun to illustrate the potential adverse cardiovascular (CV) risk profile associated with sulfonylurea (SU) use. Specifically, the use of an SU has been demonstrated to be associated with increased mortality and a higher risk of stroke with more CV events associated with SU use having been reported in subgroups of patients with a history of CV disease, elderly and a higher body mass index.
The objective of the current study was to explore the distribution of established atherosclerotic CV disease and CV risk factors amongst patients with diabetes on an SU using a Canadian primary care dataset for the 2013 calendar year.
The Canadian Primary Care Sentinel Surveillance Network (CPCSSN), which is a multi-disease surveillance system based on primary care electronic medical record data, was utilized for this research study. Patients with a diagnosis of diabetes and exposure to an SU were identified. Distribution/prevalence of CV risk profile amongst this sub-cohort was explored.
In analyzing the CPCSSN database for the 2013 calendar year, 6150 patients were identified as having diabetes, at least one visit with their family doctor, and on an SU. For this sub-cohort, demographic data was as follows: age [mean (SD)] 65.4(12.8) years-old; 56.4% male and mean BMI 31.3(10.0). Established atherosclerotic CV disease was observed in 16.8% of the patients with the following distribution: 13.2% had ischemic heart disease/myocardial infarction or coronary artery disease; 2.4% had stroke; and 2.3% had peripheral vascular disease. Regarding the aggregation of CV risk factors, a large proportion (65%) of patients without established atherosclerotic CV disease presented with 2 or more CV risk factors including: hypertension (62%), dyslipidemia (33%), active smoking (13%), and obesity (43%). Almost half of the cohort (45%) were males older than 55 years of age or females older than 60 years of age with at least one of the following risk factors: dyslipidemia, hypertension or current smoking, but without established cardiovascular disease. A large proportion of patients (19.5%) had a diagnosis of cardiac-specific issues including ischemic heart disease/myocardial infarction/coronary artery disease, heart failure (not due to ischemic heart disease/myocardial infarction/coronary artery disease), or arrhythmia. Almost 82% of patients had either established atherosclerotic CV disease or 2 or more CV risk factors without established atherosclerotic CV disease.
This study illustrated that in this dataset of Canadian patients with diabetes in a primary care setting, a substantial proportion of patients treated with an SU in 2013 had established CV disease and/or an aggregation of multiple CV risk factors. In light of recent data reporting on an association between SU utilization and CV events and increased mortality, pharmacovigilance programs should actively monitor SU utilization in patients with diabetes and a high risk CV profile in real world clinical settings.
观察性研究和荟萃分析产生的越来越多的证据已开始说明与使用磺脲类药物（SU）相关的潜在不良心血管（CV）风险状况。具体而言，已证明使用SU与死亡率增加以及中风风险较高相关，在有心血管疾病史、老年人和较高体重指数的患者亚组中，与使用SU相关的心血管事件报告得更多。
本研究的目的是利用2013日历年的加拿大初级保健数据集，探讨使用SU的糖尿病患者中已确诊的动脉粥样硬化性心血管疾病和心血管危险因素的分布情况。
本研究使用了加拿大初级保健哨点监测网络（CPCSSN），这是一个基于初级保健电子病历数据的多疾病监测系统。确定了诊断为糖尿病且使用过SU的患者。探讨了该亚组人群中心血管风险状况的分布/患病率。
在分析2013日历年的CPCSSN数据库时，确定了6150名患有糖尿病、至少看过一次家庭医生且正在使用SU的患者。该亚组人群的人口统计学数据如下：年龄[平均（标准差）]65.4（12.8）岁；男性占56.4%，平均体重指数为31.3（10.0）。16.8%的患者患有已确诊的动脉粥样硬化性心血管疾病，分布如下：13.2%患有缺血性心脏病/心肌梗死或冠状动脉疾病；2.4%患有中风；2.3%患有外周血管疾病。关于心血管危险因素的聚集情况，很大一部分（65%）没有已确诊的动脉粥样硬化性心血管疾病的患者存在2种或更多心血管危险因素，包括：高血压（62%）、血脂异常（33%）、当前吸烟（13%）和肥胖（43%）。几乎一半的队列（45%）是年龄大于55岁的男性或年龄大于60岁的女性，至少有以下危险因素之一：血脂异常、高血压或当前吸烟，但没有已确诊的心血管疾病。很大一部分患者（19.5%）被诊断患有心脏特异性疾病，包括缺血性心脏病/心肌梗死/冠状动脉疾病、心力衰竭（非由缺血性心脏病/心肌梗死/冠状动脉疾病引起）或心律失常。几乎82%的患者患有已确诊的动脉粥样硬化性心血管疾病或有2种或更多心血管危险因素但没有已确诊的动脉粥样硬化性心血管疾病。
本研究表明，在这个加拿大初级保健环境中糖尿病患者的数据集中，2013年接受SU治疗的患者中有很大一部分患有已确诊的心血管疾病和/或多种心血管危险因素聚集。鉴于最近关于SU使用与心血管事件和死亡率增加之间关联的数据报告，药物警戒计划应在现实世界临床环境中积极监测糖尿病和高心血管风险状况患者的SU使用情况。
