Mann R, Mackay F, Pearce G, Freemantle S, Wilton L
Drug Safety Research Unit, Bursledon Hall, Southampton SO31 1AA, UK.
J Hum Hypertens. 1999 Aug;13(8):551-7. doi: 10.1038/sj.jhh.1000880.
The objective of this study was to undertake a post- marketing safety surveillance study of losartan, the first specific angiotensin-II receptor antagonist to be marketed in England. It is a non-interventional observational cohort study using the technique of prescription-event monitoring. Subjects who took part in the study were from 14 522 patients treated by general practitioners in England. We recorded adverse drug reactions, adverse events, reasons for stopping the drug, pregnancies and deaths. The results were that general practitioners considered the drug to have been effective in 85.9% of the patients evaluated for effectiveness. Dizziness, malaise, lassitude, nausea, cough and headache were among the most frequently reported adverse drug reactions, reasons for stopping the drug and events of highest incidence density. None of the deaths that occurred were attributed to losartan and no serious unexpected adverse reactions or interactions were identified. In conclusion losartan has an acceptable safety profile and the study confirms the safety information given in the current Summary of Product characteristics for losartan.
本研究的目的是对氯沙坦进行上市后安全性监测研究，氯沙坦是在英国上市的首个特异性血管紧张素II受体拮抗剂。这是一项采用处方事件监测技术的非干预性观察性队列研究。参与该研究的受试者来自英国全科医生治疗的14522名患者。我们记录了药物不良反应、不良事件、停药原因、妊娠和死亡情况。结果显示，全科医生认为该药物在85.9%接受有效性评估的患者中有效。头晕、不适、乏力、恶心、咳嗽和头痛是最常报告的药物不良反应、停药原因和最高发病率密度事件。发生的死亡均与氯沙坦无关，未发现严重的意外不良反应或相互作用。总之，氯沙坦具有可接受的安全性，该研究证实了氯沙坦当前产品特性摘要中给出的安全信息。
