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.
Neurology. 2021 Sep 28;97(13):e1266-e1275. doi: 10.1212/WNL.0000000000012601. Epub 2021 Aug 13.
To determine the risk of hospitalization and death associated with pimavanserin use.
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.
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).
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.
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.
确定普拉克索使用与住院和死亡风险的关系。
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。
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。
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。
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。
