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September 28, 2021; 97 (13) Research 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
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.
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G. Caleb Alexander
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.
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Huijun An
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.
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Thomas J. Moore
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.
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Hemalkumar B. Mehta
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.
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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 Sep 2021, 97 (13) e1266-e1275; DOI: 10.1212/WNL.0000000000012601

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Abstract

Background and Objectives 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 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.

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) 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).

Discussion 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.

Classification of Evidence 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.

Glossary

ADL=
activities of daily living;
CI=
confidence interval;
FDA=
Food and Drug Administration;
HR=
hazard ratio;
ICD-10-CM=
International Classification of Diseases, Tenth Revision, Clinical Modification;
IPTW=
inverse probability of treatment weighting;
MDS=
minimum data set;
PD=
Parkinson disease

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Editorial, page 613

  • Class of Evidence: NPub.org/coe

  • CME Course: NPub.org/cmelist

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