Aagaard L, Hallgreen C E, Hansen E H
Clinical Pharmacology and Pharmacy, Department of Public Health, Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark.
Danish Pharmacovigilance Research Project (DANPREP), University of Copenhagen, Copenhagen, Denmark.
Int J Obes (Lond). 2016 Nov;40(11):1742-1747. doi: 10.1038/ijo.2016.135. Epub 2016 Aug 1.
Use of antiobesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after the time of marketing. In Europe, information about AEs reported for antiobesity medicines can be accessed in the EudraVigilance (EV) database. Therefore, we aimed to identify and characterise AEs associated with the use of antiobesity medicines in Europe.
AE reports submitted for antiobesity medicines (Anatomical Therapeutic Chemical (ATC) group A08A) from 2007 to 2014 and located in the EV database were analysed. AE data were categorised with respect to time, age and sex of patient/consumer, type of reporter, category and seriousness of reported AEs and medicines. Consumer AE reports were compared with reports from other types of reporters with respect to age and sex of consumer, seriousness, system organ class and medicine. The unit of analysis was one AE and one AE report, respectively.
We located 4941 AE reports corresponding to 13 957 AEs for antiobesity medicines in the EV database. More than 90% of all AE cases were serious, including 159 deaths. The majority of AE cases were reported for female adults. The majority of serious AEs was reported for orlistat (37%) and rimonabant (22%). The largest share of serious AEs was of the type 'cardiac disorders' (19%) and 'psychiatric disorders' (18%). Consumer AEs reporting differed from other sources with respect to share and seriousness of AEs, type of AEs (system organ class) and medicines (ATC level 5).
Many serious AEs were found for antiobesity medicines in EV, and consumers contributed with a relatively high share of reports. Although several products have been withdrawn from the market and new medicines are being marketed, the utilisation of antiobesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.
使用抗肥胖药物与严重的心脏和精神方面不良事件（AE）相关。自发报告可提供有关上市后发生的严重、罕见和未知不良事件的信息。在欧洲，可通过欧洲药物警戒数据库（EudraVigilance，EV）获取抗肥胖药物报告的不良事件信息。因此，我们旨在识别并描述欧洲与使用抗肥胖药物相关的不良事件。
对2007年至2014年提交至EV数据库且属于抗肥胖药物（解剖治疗化学分类（ATC）组A08A）的不良事件报告进行分析。不良事件数据根据患者/消费者的时间、年龄和性别、报告者类型、报告的不良事件和药物的类别及严重程度进行分类。将消费者不良事件报告与其他类型报告者的报告在消费者的年龄和性别、严重程度、系统器官分类和药物方面进行比较。分析单位分别为一个不良事件和一份不良事件报告。
我们在EV数据库中找到了4941份与抗肥胖药物相关的不良事件报告，对应13957例不良事件。所有不良事件病例中超过90%为严重不良事件，包括159例死亡。大多数不良事件病例报告的是成年女性。大多数严重不良事件报告涉及奥利司他（37%）和利莫那班（22%）。严重不良事件中占比最大的类型是“心脏疾病”（19%）和“精神疾病”（18%）。消费者报告的不良事件在不良事件的占比和严重程度、不良事件类型（系统器官分类）和药物（ATC 5级）方面与其他来源不同。
在EV中发现了许多与抗肥胖药物相关的严重不良事件，消费者报告占比较高。尽管几种产品已退出市场且有新药上市，但抗肥胖药物的使用仍然广泛，因此有必要对这些药物的安全性进行系统监测。
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