Objective: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’s 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 one 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) nor with 30-day mortality (aHR 0.76, CI 0.56–1.03). Pimavanserin use vs. nonuse was associated with an 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).Conclusions:Pimavanserin use vs. nonuse in older adults was associated with an increased risk of hospitalization at one month of initiation and a higher risk of death for up to one 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’s disease.Classification of Evidence:This study provides Class II evidence that in patients with Parkinson’s disease who are 65 or older and residing in Medicare-certified long-term care facilities, pimavanserin prescribing is associated with an increased risk of 30-day hospitalization and higher 90-, 180-, and, 365-day mortality.
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