Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, Czech Republic.
J Eval Clin Pract. 2010 Dec;16(6):1124-8. doi: 10.1111/j.1365-2753.2009.01280.x.
To investigate the relationship between patients' characteristics, use of concomitant anti-diabetic therapies and the incidence of hypoglycaemia, an acute complication of the treatment of diabetes mellitus reported by general practitioners (GPs) during the first 9 months of the treatment with pioglitazone.
We used data collected for the Prescription-Event Monitoring (PEM) study conducted by the Drug Safety Research Unit for patients prescribed pioglitazone between November 2000 and June 2001 by their GP in England. A Cox proportional-hazards regression model was used to assess this relationship.
The original pioglitazone PEM cohort included 12,772 patients (mean age 60.9 years); 53% (6777) were male. A total of 77 patients experienced at least one hypoglycaemic episode (9.64 per 1000 patient-years). Women were estimated to have twice the hazard of having a hypoglycaemic event compared with men [hazard ratio (HR) 2.05; confidence interval (CI) 1.24, 3.41]. Patients taking combination therapy with sulfonylurea or insulin were estimated to have approximately three and four times the hazard of having an event compared with those who were not taking these adjunctive therapies [HR=3.11 (CI 1.64, 5.88); HR=4.15 (CI 1.74, 9.91), respectively]. Patients treated with adjunctive metformin were 25% less likely to experience hypoglycaemia than those who did not take concomitant metformin (HR=0.75; CI 0.44, 1.27).
This study has shown that the treatment with pioglitazone was associated with a low incidence of hypoglycaemia. The factors possibly increasing the risk of hypoglycaemia were concomitant therapy with sulfonylurea or insulin and female gender.
调查患者特征、联合使用抗糖尿病治疗与低血糖发生率之间的关系，这是糖尿病治疗的急性并发症，由全科医生（GP）在吡格列酮治疗的前 9 个月报告。
我们使用了在 2000 年 11 月至 2001 年 6 月期间由英格兰的全科医生为患者开处方的药物安全研究单位进行的处方事件监测（PEM）研究中收集的数据。使用 Cox 比例风险回归模型来评估这种关系。
原始吡格列酮 PEM 队列包括 12772 名患者（平均年龄 60.9 岁）；53%（6777 名）为男性。共有 77 名患者至少经历过一次低血糖发作（每 1000 患者年 9.64 次）。与男性相比，女性发生低血糖事件的风险估计为两倍[风险比（HR）2.05；置信区间（CI）1.24，3.41]。与未接受这些辅助治疗的患者相比，同时使用磺酰脲或胰岛素的患者发生事件的风险估计约为三倍和四倍[HR=3.11（CI 1.64，5.88）；HR=4.15（CI 1.74，9.91）]。接受辅助二甲双胍治疗的患者发生低血糖的可能性比未服用二甲双胍的患者低 25%（HR=0.75；CI 0.44，1.27）。
这项研究表明，吡格列酮治疗与低血糖发生率低有关。可能增加低血糖风险的因素是磺酰脲或胰岛素的联合治疗和女性性别。
