Biswas P N, Wilton L V, Shakir S W
Drug Safety Research Unit, Bursledon Hall, Southampton SO31 1AA, UK.
J Hum Hypertens. 2002 Nov;16(11):795-803. doi: 10.1038/sj.jhh.1001490.
Valsartan is a second class of angiotensin II receptor antagonist, indicated for the treatment of hypertension. The objective of the study was to monitor the safety of valsartan using the technique of prescription event monitoring (PEM), in patients who were prescribed this drug by general practitioners (GPs) in England. PEM is a noninterventional observation cohort technique. Exposure data were obtained from dispensed prescriptions issued between December 1996 and November 1998. Outcome data were obtained by sending questionnaires to prescribing GPs. The cohort comprised 12881 patients. Events most frequently reported as suspected adverse drug reactions were malaise/lassitude (37; 0.3% of total cohort), dizziness (19; 0.1%), and unspecified side effects (57; 0.4%). Events with the highest incidence density (ID(1) per 1000 patient-months of treatment) in the first month of treatment were malaise/lassitude (15.6), dizziness (11.8), and headache/migraine (10.9). Most frequent reasons for stopping valsartan were not effective (847; 6.6% of total cohort), malaise/lassitude (265; 21%), and dizziness (146; 1.1%). No unexpected serious adverse events were identified. Other events assessed as possibly related to valsartan use were impotence (37), dizziness (19), cough (9), facial oedema (5), hyperkalaemia (3), and angioneurotic oedema (1). There were four reports of exposure during pregnancy and 203 deaths (1.5%) in this cohort. In conclusion, this study monitored the safety profile of valsartan in a large cohort of patients in general practice in England. No untoward features other than dizziness were identified that were not mentioned in the prescribing guidance.
缬沙坦是第二类血管紧张素II受体拮抗剂，用于治疗高血压。本研究的目的是使用处方事件监测（PEM）技术，监测在英国由全科医生（GP）开具此药的患者中缬沙坦的安全性。PEM是一种非干预性观察队列技术。暴露数据来自1996年12月至1998年11月期间发放的处方。通过向开处方的全科医生发送问卷来获取结果数据。该队列包括12881名患者。最常报告为疑似药物不良反应的事件是不适/乏力（37例；占总队列的0.3%）、头晕（19例；0.1%）和未明确的副作用（57例；0.4%）。治疗第一个月发病率密度最高（每1000患者月治疗的ID(1)）的事件是不适/乏力（15.6）、头晕（11.8）和头痛/偏头痛（10.9）。停用缬沙坦最常见的原因是无效（847例；占总队列的6.6%）、不适/乏力（265例；2.1%）和头晕（146例；1.1%）。未发现意外的严重不良事件。其他被评估为可能与使用缬沙坦有关的事件包括阳痿（37例）、头晕（19例）、咳嗽（9例）、面部水肿（5例）、高钾血症（3例）和血管神经性水肿（1例）。该队列中有4例孕期暴露报告和203例死亡（1.5%）。总之，本研究监测了英国一大群全科医疗患者中缬沙坦的安全性概况。除头晕外，未发现处方指南中未提及的不良特征。
