Institute for Medical Biometry, Informatics and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, North Rhine-Westphalia, Germany.
Research Division, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, North Rhine-Westphalia, Germany.
BMC Pharmacol Toxicol. 2020 Mar 23;21(1):25. doi: 10.1186/s40360-020-0392-9.
Older adults are more prone to develop adverse drug reactions (ADRs) since they exhibit numerous risk factors. The first aim was to analyse the number of spontaneous ADR reports regarding older adults (> 65) in the ADR database of the German Federal Institute for Drugs and Medical Devices (BfArM) and to set them in relation to i) the number of ADR reports concerning younger adults (19-65), and ii) the number of inhabitants and assumed drug-exposed inhabitants. The second aim was to analyse, if reported characteristics occurred more often in older vs. younger adults.
All spontaneous ADR reports involving older or younger adults within the period 01/01/2000-10/31/2017 were identified in the ADR database. Ratios concerning the number of ADR reports/number of inhabitants and ADR reports/drug-exposed inhabitants were calculated. The reports for older (n = 69,914) and younger adults (n = 111,463) were compared using descriptive and inferential statistics.
The absolute number of ADR reports involving older adults increased from 1615 (2000) up to 5367 ADR reports (2016). The age groups 76-84 and 70-79 had the highest number of ADR reports with 25 ADR reports per 100,000 inhabitants and 27 ADR reports per 100,000 assumed drug-exposed inhabitants. For both ratios, the number of reports was higher for males (26 and 28 ADR reports) than for females (24 and 26 ADR reports). Fatal outcome was reported almost three times more often in older vs. younger adults. Six out of ten drug substances most frequently suspected were antithrombotics (vs. 1/10 in younger adults). For some drug substances (e.g. rivaroxaban) the ADRs reported most frequently differed between older (epistaxis) and younger adults (menorrhagia).
There is a need to further investigate ADRs in older adults since they occurred more frequently in older vs. younger adults and will likely increase in future. Physicians should be aware of different ADRs being attributed to the same drug substances which may be more prominent in older adults. Regular monitoring of older adults taking antithrombotics is recommended.
老年人更容易发生药物不良反应（ADR），因为他们存在许多风险因素。第一个目标是分析德国联邦药品和医疗器械研究所（BfArM）ADR 数据库中涉及老年人（>65 岁）的自发 ADR 报告数量，并将其与以下因素相关联：i）涉及年轻成年人（19-65 岁）的 ADR 报告数量，以及 ii）居民人数和假设的药物暴露居民人数。第二个目标是分析报告的特征是否在老年人中比在年轻人中更常见。
在 2000 年 1 月 1 日至 2017 年 10 月 31 日期间，在 ADR 数据库中确定了涉及老年人或年轻人的所有自发 ADR 报告。计算 ADR 报告数量/居民人数和 ADR 报告/药物暴露居民人数的比例。使用描述性和推断性统计方法比较老年人（n=69914）和年轻人（n=111463）的报告。
涉及老年人的 ADR 报告绝对数量从 2000 年的 1615 份增加到 2016 年的 5367 份。年龄组 76-84 岁和 70-79 岁的 ADR 报告数量最多，每 100000 名居民中有 25 份 ADR 报告，每 100000 名假设的药物暴露居民中有 27 份 ADR 报告。对于这两个比例，男性的报告数量（26 和 28 份 ADR 报告）高于女性（24 和 26 份 ADR 报告）。与年轻人相比，老年人的致命结局报告几乎高出三倍。最常怀疑的十种药物中有六种是抗血栓药物（年轻人中占十分之一）。对于一些药物（如利伐沙班），老年人（鼻出血）和年轻人（月经过多）报告的 ADR 最常见。
需要进一步研究老年人的 ADR，因为它们在老年人中比在年轻人中更常见，而且未来可能会增加。医生应该意识到同一药物可能归因于不同的 ADR，这些 ADR 在老年人中可能更为突出。建议定期监测使用抗血栓药物的老年人。
