Davies Miranda, Wilton Lynda V, Shakir Saad A W
Drug Safety Research Unit, Southampton, UK.
Drug Saf. 2008;31(4):313-23. doi: 10.2165/00002018-200831040-00005.
Esomeprazole, the S-isomer of omeprazole, was launched in the UK in September 2000. The first proton pump inhibitor, omeprazole, has been marketed in the UK for over 10 years. However, the adverse event database of newly marketed drugs is limited, and it is only after widespread clinical use that the adverse effect profile of a drug is ascertained more comprehensively. This study aims to monitor the safety of esomeprazole prescribed in the primary care setting in England using prescription-event monitoring (PEM).
A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions for esomeprazole issued by general practitioners between September 2000 and April 2001. Questionnaires ('green forms') requesting clinical event data on these patients were sent to prescribers approximately 6 months after the date of the first dispensed prescription for each individual patient. Incidence densities (IDs), expressed as the number of first reports of an event/1000 patient-months of exposure (PME), were calculated. Significant differences between IDs for events reported in the first month (ID1) and the following 5 months (ID2-6) of exposure were regarded as potential signals. Other methods for signal detection such as medical evaluation of selected events and evaluation of reasons for stopping were also applied.
Green forms containing clinically useful information for 11 595 patients (median age 56 years; 53.2% female) were received. Diarrhoea was the event with the highest ID1 in month 1 (8.0 per 1000 patient months of exposure). Adverse events that occurred significantly more often in the first month of treatment with esomeprazole compared with months 2-6 included diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, headache/migraine, intolerance, malaise/lassitude, pruritus, unspecified adverse effects and abnormal sensation.
The safety profile of esomeprazole was consistent with the prescribing information and experience reported in the literature.
埃索美拉唑是奥美拉唑的S-异构体，于2000年9月在英国上市。首个质子泵抑制剂奥美拉唑已在英国上市超过10年。然而，新上市药物的不良事件数据库有限，只有在广泛临床应用后才能更全面地确定药物的不良反应情况。本研究旨在通过处方事件监测（PEM）来监测英格兰基层医疗环境中开具的埃索美拉唑的安全性。
采用PEM的观察性队列技术进行上市后监测研究。从2000年9月至2001年4月期间全科医生开具的埃索美拉唑配药处方中识别患者。在每位患者首次配药处方日期约6个月后，向开处方者发送问卷（“绿色表格”），要求提供这些患者的临床事件数据。计算发病率密度（ID），以事件首次报告数/1000患者月暴露量（PME）表示。暴露第一个月（ID1）和接下来5个月（ID2 - 6）报告的事件ID之间的显著差异被视为潜在信号。还应用了其他信号检测方法，如对选定事件的医学评估和停药原因评估。
收到了包含11595名患者（中位年龄56岁；53.2%为女性）临床有用信息的绿色表格。腹泻是第1个月ID1最高的事件（每1000患者月暴露量为8.0）。与第2 - 6个月相比，埃索美拉唑治疗第一个月显著更常发生的不良事件包括腹泻、恶心/呕吐、腹痛、消化不良、头痛/偏头痛、不耐受、不适/倦怠、瘙痒、未指明的不良反应和异常感觉。
埃索美拉唑的安全性概况与文献中报道的处方信息和经验一致。
