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

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.

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

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