Patients with Parkinson’s disease (PD) treated with pimavanserin, a novel antipsychotic, have a higher risk of hospitalization after 1 month of use and an increased risk of death up to 1 year after starting treatment, according to the study results published in became neurology.
The US Food and Drug Administration (FDA) has approved pimavanserin for the treatment of hallucinations and delusions in patients with Parkinson’s disease. Previous studies have found an unfavorable trend in deaths in patients using this drug. Research has shown that typical and atypical antipsychotics are likely to more than double the risk of death in this population.
The current aim of this study was to assess the risk of hospitalization and death associated with the use of pimavanserin in older adults with PD.
The retrospective study included patients with PD ≥ 65 years of age, including 2,186 patients taking pimavanserin and 18,212 non-users. Patient data was obtained from administrative records that included residents of Medicare-certified long-term care facilities, in addition to linked Medicare entitlement data.
Pimavanserin users and non-users were weighed on the basis of a total of 24 baseline characteristics with an inverse probability of treatment weighting (IPTW) based on the propensity score. Researchers estimated the risk of hospitalization and death up to one year using Fine-Gray regression models for competing risks and Cox proportional hazards regression models, respectively.
It was estimated that patients taking pimavanserin had a higher risk of a 30-day hospital stay compared to non-users (IPTW adjusted hazard ratio [aHR], 1.24; 95% CI, 1.06-1.43). In contrast, there was no association between treatment with pimavanserin and hospitalization after 90 days (aHR 1.10; 95% CI 0.99–1.24) or mortality after 30 days (aHR 0.76; 95% -KI 0.56-1.03).
However, patients taking pimavanserin had an increased 90-day mortality risk (aHR 1.20, CI 1.02–1.41) compared to non-users, and this associated risk persisted even after a full 180 days (aHR 1 , 28; 95% CI 1.13-1.45.). ) and up to 1 year (aHR 1.56; 95% CI 1.42–1.72).
One limitation of the study included its observational nature, which the researchers propose to subject the results to residual confusion. Also, given the study, which included long-term care patients with Parkinson’s, the researchers note that the results may not generalize to older adults in the community or to patients who received pimavanserin for other medical conditions.
Despite these limitations, the researchers concluded that the “results may influence the risk-benefit assessment and clinical decisions in” patients with advanced Parkinson’s disease.
Hwang YJ, Alexander GC, An H, et al. Risk of hospitalization and death associated with the use of pimavanserin in older adults with Parkinson’s disease. Neurology. Published online 13 August 2021. doi: 10.1212 / WNL.0000000000012601