Geldmacher David S, Provenzano George, McRae Thomas, Mastey Vera, Ieni John R
University Memory and Aging Center, University Hospitals Research Institute, Cleveland, Ohio, USA.
J Am Geriatr Soc. 2003 Jul;51(7):937-44. doi: 10.1046/j.1365-2389.2003.51306.x.
To assess the relationship between donepezil treatment and time to nursing home placement (NHP) for patients with Alzheimer's disease (AD).
Observational follow-up of patient NHP and vital status.
Community.
Patients previously enrolled in one of three randomized, double-blind, placebo-controlled clinical trials of donepezil and two subsequent open-label studies (total N = 1,115); 671 patients provided complete data for analysis.
Data were obtained through follow-up interviews with caregivers and chart reviews of patients with AD. Comparison groups were defined by whether patients received an effective dose of donepezil (>/=5 mg/d; >/=80% compliance) for specific numbers of weeks during the double-blind or open-label trial phase, in both phases, or in neither. Cox proportional hazards models were used to estimate risk ratios for NHP and survival curves from which median times to NHP were estimated for first dementia-related placement of longer than 2 weeks and permanent placement. The models were adjusted for age, sex, baseline Mini-Mental State Examination score, whether the caregiver was a spouse, caregiver continuity, and use of other cholinesterase inhibitors after the clinical trials.
Use of donepezil of 5 mg/d or more was associated with significant delays in NHP. A cumulative dose-response relationship was observed between longer-term sustained donepezil use and delay of NHP. When donepezil was taken at an effective dose for at least 9 to 12 months, conservative estimates of the time gained before NHP were 21.4 months for first dementia-related NHP and 17.5 months for permanent NHP.
Use of donepezil by AD patients resulted in significant delays in NHP. Long-term use of donepezil may help AD patients live longer in community settings, with consequent personal, social, and economic benefits.
评估多奈哌齐治疗与阿尔茨海默病(AD)患者入住养老院时间(NHP)之间的关系。
对患者NHP和生命状态进行观察性随访。
社区。
先前参加过三项多奈哌齐随机、双盲、安慰剂对照临床试验之一以及两项后续开放标签研究的患者(共N = 1115例);671例患者提供了完整数据用于分析。
通过对照料者的随访访谈和AD患者病历审查获取数据。比较组根据患者在双盲或开放标签试验阶段、两个阶段或两个阶段均未接受特定周数的有效剂量多奈哌齐(≥5 mg/d;依从性≥80%)来定义。使用Cox比例风险模型估计NHP的风险比和生存曲线,从中估计首次痴呆相关入住超过2周和永久入住的NHP中位时间。模型对年龄、性别、基线简易精神状态检查评分、照料者是否为配偶、照料者连续性以及临床试验后是否使用其他胆碱酯酶抑制剂进行了校正。
使用5 mg/d或更高剂量的多奈哌齐与NHP显著延迟相关。观察到长期持续使用多奈哌齐与NHP延迟之间存在累积剂量反应关系。当以有效剂量服用多奈哌齐至少9至12个月时,首次痴呆相关NHP之前获得时间的保守估计为21.4个月,永久NHP为17.5个月。
AD患者使用多奈哌齐导致NHP显著延迟。长期使用多奈哌齐可能有助于AD患者在社区环境中生活更长时间,从而带来个人、社会和经济效益。