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August 13, 2021Research Article

Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease

Y. Joseph Hwang, G. Caleb Alexander, Huijun An, Thomas J Moore, Hemalkumar B Mehta
First published August 13, 2021, DOI: https://doi.org/10.1212/WNL.0000000000012601
Y. Joseph Hwang
1Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD
2Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD
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G. Caleb Alexander
1Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD
2Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD
3Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
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Huijun An
3Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
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Thomas J Moore
2Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD
4Institute for Safe Medication Practices, Alexandria, VA
5Department of Epidemiology, Milken Institute School of Public Health, George Washington University, Washington, DC
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Hemalkumar B Mehta
2Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD
3Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
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Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease
Y. Joseph Hwang, G. Caleb Alexander, Huijun An, Thomas J Moore, Hemalkumar B Mehta
Neurology Aug 2021, 10.1212/WNL.0000000000012601; DOI: 10.1212/WNL.0000000000012601

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Abstract

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.

  • Received February 22, 2021.
  • Accepted in final form July 12, 2021.
  • © 2021 American Academy of Neurology

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Disputes & Debates: Rapid online correspondence

  • Author Response: Retrospective Study of Pimavanserin Use in Older Adults With Parkinson's Disease
    • Y. Joseph Hwang, Assistant Professor of Medicine, Johns Hopkins University
    • G. Caleb Alexander, Professor of Epidemiology and Medicine, Johns Hopkins University
    • Thomas J. Moore, Senior Scientist, Institute For Safe Medication Practices
    • Hemalkumar B. Mehta, Assistant Professor of Epidemiology, Johns Hopkins University
    Submitted September 22, 2021
  • Reader Response: Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease
    • Jeffrey L Cummings, Neurologist; Professor, University of Nevada Las Vegas
    • Pierre Tariot, Psychiatrist, Banner Alzheimer's Institute
    • George Grossberg, Psychiatrist, University of St. Louis
    • Devangere Davanand, Psychiatrist, Columbia University
    Submitted September 09, 2021
  • Reader Response: Retrospective Study of Pimavanserin Use in Older Adults With Parkinson's Disease
    • Ponni Subbiah, Global Head of Medical Affairs and Chief Medical Officer, Acadia Pharmaceuticals, Inc
    • Dilesh Doshi, Vice President of Health Economics & Outcomes Research, Acadia Pharmaceuticals, Inc
    • Mary Ellen Turner, Corporate Safety Officer, Acadia Pharmaceuticals, Inc
    Submitted September 02, 2021
  • Reader Response: Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease
    • Joshua D Brown, Assistant Professor, University of Florida
    • Michael S Okun, Adelaide Lackner Professor and Chair of Neurology, University of Florida
    • Melissa J Armstrong, Associate Professor, University of Florida
    Submitted August 31, 2021

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