与帕金森病老年患者使用 pimavanserin 相关的住院和死亡风险。
Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease.
机构信息
From the Department of Medicine (Y.J.H., G.C.A.), Johns Hopkins University School of Medicine; Center for Drug Safety and Effectiveness (Y.J.H., G.C.A., T.J.M., H.B.M.), Johns Hopkins University; Department of Epidemiology (G.C.A., H.A., H.B.M.), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; Institute for Safe Medication Practices (T.J.M.), Alexandria, VA; and Department of Epidemiology (T.J.M.), Milken Institute School of Public Health, George Washington University, Washington, DC.
出版信息
Neurology. 2021 Sep 28;97(13):e1266-e1275. doi: 10.1212/WNL.0000000000012601. Epub 2021 Aug 13.
BACKGROUND AND OBJECTIVES
To determine the risk of hospitalization and death associated with pimavanserin use.
METHODS
We conducted a retrospective cohort study of adults 65 years and older with Parkinson disease between November 1, 2015, and December 31, 2018, using an administrative dataset on residents of Medicare-certified long-term care facilities and linked Medicare claims data. Propensity score-based inverse probability of treatment weighting (IPTW) was used to balance pimavanserin users and nonusers on 24 baseline characteristics. Fine-Gray competing risk and Cox proportional hazards regression models were used to estimate the risk of hospitalization and death up to 1 year, respectively.
RESULTS
The study cohort included 2,186 pimavanserin users and 18,212 nonusers. There was a higher risk of 30-day hospitalization with pimavanserin use vs nonuse (IPTW-adjusted hazard ratio [aHR] 1.24, 95% confidence intervals [CI] 1.06-1.43). There was no association of pimavanserin use with 90-day hospitalization (aHR 1.10, CI 0.99-1.24) or with 30-day mortality (aHR 0.76, CI 0.56-1.03). Pimavanserin use vs nonuse was associated with increased 90-day mortality (aHR 1.20, CI 1.02-1.41) that persisted after 180 days (aHR 1.28, CI 1.13-1.45) and 1 year (aHR 1.56, CI 1.42-1.72).
DISCUSSION
Pimavanserin use vs nonuse in older adults was associated with an increased risk of hospitalization at 1 month of initiation and a higher risk of death for up to 1 year following initiation. These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk/benefit balance among patients with Parkinson disease.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that in patients with Parkinson disease who are 65 or older and residing in Medicare-certified long-term care facilities, pimavanserin is associated with an increased risk of 30-day hospitalization and higher 90-, 180-, and 365-day mortality.
背景与目的
确定普拉克索使用与住院和死亡风险的关系。
方法
我们对 2015 年 11 月 1 日至 2018 年 12 月 31 日期间，居住在医疗保险认证的长期护理机构的成年人（年龄≥65 岁且患有帕金森病）进行了回顾性队列研究，并使用居民的行政数据集和医疗保险索赔数据进行了关联。采用倾向评分逆概率处理加权（IPTW）法，对 24 项基线特征进行平衡，比较普拉克索使用者和非使用者。采用 Fine-Gray 竞争风险和 Cox 比例风险回归模型分别估计 1 年内住院和死亡的风险。
结果
该研究队列包括 2186 名普拉克索使用者和 18212 名非使用者。与非使用者相比，普拉克索使用者在 30 天内住院的风险更高（经 IPTW 校正的风险比[aHR]1.24，95%置信区间[CI]1.06-1.43）。普拉克索使用者与 90 天内住院（aHR 1.10，CI 0.99-1.24）或 30 天内死亡率（aHR 0.76，CI 0.56-1.03）无关。与非使用者相比，普拉克索使用者在 90 天内的死亡率更高（aHR 1.20，CI 1.02-1.41），且在 180 天（aHR 1.28，CI 1.13-1.45）和 1 年（aHR 1.56，CI 1.42-1.72）时持续存在。
讨论
在老年患者中，与非使用者相比，普拉克索使用者在起始后 1 个月内的住院风险增加，起始后 1 年内的死亡风险更高。在长期护理机构的大型真实世界队列中，这些发现可能有助于为帕金森病患者提供有关其风险/获益平衡的决策信息。
证据分类
这项研究提供了 II 级证据，表明在 65 岁或以上且居住在医疗保险认证的长期护理机构的帕金森病患者中，普拉克索与 30 天内住院风险增加以及 90 天、180 天和 365 天死亡率更高相关。
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