van Staa T, Abenhaim L, Monette J
Centre for Clinical Epidemiology and Community Studies, Jewish General Hospital, Montreal, Quebec, Canada.
J Clin Epidemiol. 1997 Jun;50(6):735-41. doi: 10.1016/s0895-4356(97)00024-3.
To identify the demographic and clinical characteristics of sulfonylurea users. To assess the risk of hypoglycemia in patients treated with sulfonylureas in clinical practice, and to characterize the risk in relation to the different drugs used.
A cohort of 33,243 sulfonylurea users chosen from 719 clinical practices in the United Kingdom were identified through the VAMP-Research database. Information on demographic characteristics, medical diagnoses and use of medical services was obtained through the computerized records. For a stratified sample of 500 patients, general practioners completed a structured questionnaire on the duration, treatment, and complications of diabetes mellitus, obesity, alcohol use, and smoking history. Patients with a diagnosis of hypoglycemia, as recorded in the database within a time-window of a sulfonylurea prescription, were identified. Incidence rates per person-year of sulfonylurea therapy were estimated.
Other than a longer duration of diabetes in users of chlorpropamide, no differences were observed among users of different sulfonylurea agents with respect to diabetic complications, adequacy of diabetic control, obesity, smoking, and excessive alcohol consumption. A diagnosis of hypoglycemia during sulfonylurea therapy was recorded in 605 people over 34,052 person-years of sulfonylurea therapy, which converted into an annual risk of 1.8%. The risk in glibenclamide users was higher than in users of other types of sulfonylureas uses. Duration of therapy, concomitant use of insulin, sulfonylurea-potentiating or antagonizing and concomitant use of beta-blockers were predictive of the risk of developing hypoglycemia.
Drug use patterns showed comparability among users of different sulfonylurea agents. Our findings suggest that the rate of diagnosis of hypoglycemia made by physicians is higher for glibenclamide than for other sulfonylureas. An epidemiological study with objectively diagnosed hypoglycemia should be undertaken to confirm these results.
确定使用磺脲类药物患者的人口统计学和临床特征。评估临床实践中接受磺脲类药物治疗患者的低血糖风险,并描述与所使用的不同药物相关的风险特征。
通过VAMP研究数据库,从英国719家临床机构中选取了33243名使用磺脲类药物的患者组成队列。通过计算机化记录获取有关人口统计学特征、医学诊断和医疗服务使用情况的信息。对于500名患者的分层样本,全科医生完成了一份关于糖尿病病程、治疗、并发症、肥胖、饮酒和吸烟史的结构化问卷。确定在磺脲类药物处方的时间窗口内数据库中记录有低血糖诊断的患者。估计每人每年磺脲类药物治疗的发病率。
除氯磺丙脲使用者的糖尿病病程较长外,不同磺脲类药物使用者在糖尿病并发症、糖尿病控制的充分性、肥胖、吸烟和过量饮酒方面未观察到差异。在34052人年的磺脲类药物治疗中,有605人在磺脲类药物治疗期间被诊断为低血糖,转化为年风险为1.8%。格列本脲使用者的风险高于其他类型磺脲类药物使用者。治疗持续时间、胰岛素的同时使用、磺脲类药物增效或拮抗作用以及β受体阻滞剂的同时使用可预测发生低血糖的风险。
不同磺脲类药物使用者的用药模式具有可比性。我们的研究结果表明,医生对格列本脲低血糖的诊断率高于其他磺脲类药物。应进行一项客观诊断低血糖的流行病学研究以证实这些结果。