Campbell Noll L, Perkins Anthony J, Gao Sujuan, Skaar Todd C, Li Lang, Hendrie Hugh C, Fowler Nicole, Callahan Christopher M, Boustani Malaz A
Department of Pharmacy Practice, Purdue University School of Pharmacy, West Lafayette, Indiana.
Indiana University Center for Aging Research, Indianapolis, Indiana.
J Am Geriatr Soc. 2017 Jul;65(7):1497-1504. doi: 10.1111/jgs.14827. Epub 2017 Mar 14.
BACKGROUND/OBJECTIVES: Post-marketing comparative trials describe medication use patterns in diverse, real-world populations. Our objective was to determine if differences in rates of adherence and tolerability exist among new users to acetylcholinesterase inhibitors (AChEI's).
Pragmatic randomized, open label comparative trial of AChEI's currently available in the United States.
Four memory care practices within four healthcare systems in the greater Indianapolis area.
Eligibility criteria included older adults with a diagnosis of possible or probable Alzheimer's disease (AD) who were initiating treatment with an AChEI. Participants were required to have a caregiver to complete assessments, access to a telephone, and be able to understand English. Exclusion criteria consisted of a prior severe adverse event from AChEIs.
Participants were randomized to one of three AChEIs in a 1:1:1 ratio and followed for 18 weeks.
Caregiver-reported adherence, defined as taking or not taking study medication, and caregiver-reported adverse events, defined as the presence of an adverse event.
196 participants were included with 74.0% female, 30.6% African Americans, and 72.9% who completed at least twelfth grade. Discontinuation rates after 18 weeks were 38.8% for donepezil, 53.0% for galantamine, and 58.7% for rivastigmine (P = .063) in the intent to treat analysis. Adverse events and cost explained 73.1% and 25.4% of discontinuation. No participants discontinued donepezil due to cost. Adverse events were reported by 81.2% of all participants; no between-group differences in total adverse events were statistically significant.
This pragmatic comparative trial showed high rates of adverse events and cost-related non-adherence with AChEIs. Interventions improving adherence and persistence to AChEIs may improve AD management.
Clinicaltrials.gov: NCT01362686 (https://clinicaltrials.gov/ct2/show/NCT01362686).
背景/目的：上市后比较试验描述了不同现实世界人群中的药物使用模式。我们的目的是确定乙酰胆碱酯酶抑制剂（AChEI）新使用者在依从率和耐受性方面是否存在差异。
对美国目前可用的AChEI进行实用随机、开放标签比较试验。
大印第安纳波利斯地区四个医疗系统内的四个记忆护理机构。
纳入标准包括诊断为可能或很可能患有阿尔茨海默病（AD）且开始使用AChEI治疗的老年人。参与者需要有一名护理人员来完成评估、能够使用电话并能理解英语。排除标准包括既往有AChEI严重不良事件。
参与者按1:1:1的比例随机分配至三种AChEI之一，并随访18周。
护理人员报告的依从性，定义为是否服用研究药物；护理人员报告的不良事件，定义为是否存在不良事件。
共纳入196名参与者，其中74.0%为女性，30.6%为非裔美国人，72.9%至少完成了十二年级学业。在意向性分析中，18周后多奈哌齐的停药率为38.8%，加兰他敏为53.0%，卡巴拉汀为58.7%（P = 0.063）。不良事件和费用分别解释了停药原因的73.1%和25.4%。没有参与者因费用原因停用多奈哌齐。81.2%的参与者报告了不良事件；各组之间总不良事件的差异无统计学意义。
这项实用比较试验显示，AChEI的不良事件发生率和与费用相关的不依从率较高。改善对AChEI的依从性和持续性的干预措施可能会改善AD的管理。
Clinicaltrials.gov：NCT01362686（https://clinicaltrials.gov/ct2/show/NCT01362686）。
