Alipour-Haris Golnoosh, Armstrong Melissa J, Okun Michael, Brown Joshua D
Center for Drug Evaluation & Safety and The Department of Pharmaceutical Outcomes & Policy University of Florida College of Pharmacy Gainesville Florida USA.
Norman Fixel Institute for Neurological Diseases and the Department of Neurology University of Florida College of Medicine Gainesville Florida USA.
Mov Disord Clin Pract. 2023 Jan 10;10(3):406-414. doi: 10.1002/mdc3.13652. eCollection 2023 Mar.
Pimavanserin is currently the only antipsychotic approved for Parkinson's disease (PD) psychosis, yet its relative safety compared with treatment alternatives has not been thoroughly assessed.
This study aimed to compare hospitalization and mortality risk in Medicare beneficiaries with PD receiving new prescriptions of pimavanserin or quetiapine for PD psychosis.
The study identified new users of pimavanserin and quetiapine from a 15% national sample of Medicare fee-for-service claims collected between May 1, 2016, and December 30, 2018. All-cause hospitalization and mortality were assessed in time-to-event regression models. Standardized mortality ratio weighting balanced pimavanserin and quetiapine users on baseline characteristics. Follow-up was censored at discontinuation, switch, disenrollment, or the end of the study period.
There were 844 new pimavanserin users and 2505 new quetiapine users. The adjusted hazard ratios (95% confidence intervals [CIs]) for hospitalization at 30, 90, 180, and 365 days for pimavanserin versus quetiapine users were 0.59 (0.43-0.81), 0.56 (0.44-0.72), 0.63 (0.52-0.77), and 0.70 (0.60-0.83). The most common reasons for hospitalization were traumatic injury and sepsis. Hospitalizations for heart-related issues were higher with pimavanserin ( < 0.05). The adjusted hazard ratios (95% CIs) for all-cause mortality at 90, 180, and 365 days for pimavanserin versus quetiapine users were 0.73 (0.48-1.13), 0.80 (0.58-1.10), and 0.94 (0.74-1.19).
Risk of hospitalization was lower in pimavanserin users compared with quetiapine, and no difference in mortality was observed between pimavanserin and quetiapine. An active comparator analyses with treatment alternatives provided the most clinically relevant information for patients and physicians.
匹莫范色林是目前唯一被批准用于治疗帕金森病(PD)精神病的抗精神病药物,但其与其他治疗药物相比的相对安全性尚未得到全面评估。
本研究旨在比较接受匹莫范色林或喹硫平新处方治疗PD精神病的医疗保险受益人的住院率和死亡率风险。
该研究从2016年5月1日至2018年12月30日收集的15%的全国医疗保险按服务收费索赔样本中确定了匹莫范色林和喹硫平的新使用者。在事件发生时间回归模型中评估全因住院率和死亡率。标准化死亡率比值加权使匹莫范色林和喹硫平使用者的基线特征达到平衡。随访在停药、换药、退出研究或研究期结束时进行截尾。
有844名匹莫范色林新使用者和2505名喹硫平新使用者。匹莫范色林使用者与喹硫平使用者在30、90、180和365天时住院的调整后风险比(95%置信区间[CI])分别为0.59(0.43 - 0.81)、0.56(0.44 - 0.72)、0.63(0.52 - 0.77)和0.70(0.60 - 0.83)。住院的最常见原因是创伤性损伤和败血症。匹莫范色林使用者因心脏相关问题住院的比例更高(<0.05)。匹莫范色林使用者与喹硫平使用者在90、180和365天时全因死亡率的调整后风险比(95%CI)分别为0.73(0.48 - 1.13)、0.80(0.58 - 1.10)和0.94(0.74 - 1.19)。
与喹硫平相比,匹莫范色林使用者的住院风险较低,且未观察到匹莫范色林和喹硫平在死亡率方面存在差异。与其他治疗药物进行的活性对照分析为患者和医生提供了最具临床相关性的信息。