Strampelli Anna, Cerreta Francesca, Vučić Katarina
Imperial College London, London, UK.
European Medicines Agency (EMA), Amsterdam, Netherlands.
Br J Clin Pharmacol. 2020 Oct;86(10):1912-1920. doi: 10.1111/bcp.14462. Epub 2020 Jul 26.
The aim of this study was to elucidate drug prescription patterns in older European people with the objective to support regulatory contextualisation of (1) the suitability of enrolment criteria for new clinical trials; and (2) the understanding of the potential interactions/incompatibilities of newly authorised medicines with those most frequently used by older people.
Medicines agencies in Portugal, Poland, Slovakia and England were approached to provide a list of the 10 most frequent prescriptions in 2016 for systemically used medicines per active substances (i.e. ATC level 5), in older people. For each active substance and for the most common therapeutic subgroups (i.e. ATC level 2), the percentages of older patients receiving at least one prescription were calculated per older age categories (65-74; 75-84; 85+) and gender.
There was considerable alignment in the most commonly prescribed active substances and therapeutic subgroups represented; these were gastroprotectants (A02), lipid-modifying agents (C10) and analgesics (N02). Some gender differences were observed (A02 and N02 were prescribed more frequently to women), but trends on age categories were consistent; A02 and N02 prescriptions continued to rise with age, while C10 slightly decreased in the 85+ age group in all countries.
The findings of this study are consistent with the major chronic diseases reported in the older European population. Evidence on co-medication of newly applied medicines with the currently identified most commonly used medicines in older people should be generated during the (non)clinical development of new medicines to support regulatory assessment and adequate user information.
本研究旨在阐明欧洲老年人的药物处方模式,以支持对以下方面进行监管背景分析:(1)新临床试验入组标准的适用性;(2)理解新批准药物与老年人最常用药物之间的潜在相互作用/不相容性。
联系了葡萄牙、波兰、斯洛伐克和英国的药品管理机构,要求提供2016年按活性物质(即ATC第5级)列出的老年人全身用药物中最常用的10种处方清单。对于每种活性物质和最常见的治疗亚组(即ATC第2级),计算每个老年年龄组(65 - 74岁;75 - 84岁;85岁及以上)和性别的接受至少一种处方的老年患者百分比。
在所代表的最常用活性物质和治疗亚组方面存在相当大的一致性;这些是胃保护剂(A02)、调脂药(C10)和镇痛药(N02)。观察到一些性别差异(A02和N02在女性中处方更频繁),但年龄组趋势一致;在所有国家,A02和N02的处方随年龄持续增加,而C10在85岁及以上年龄组略有下降。
本研究结果与欧洲老年人群中报告的主要慢性病一致。在新药的(非)临床开发过程中,应获取新应用药物与目前确定的老年人最常用药物联合用药的证据,以支持监管评估和提供充分的用户信息。