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Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson's disease psychosis.

Abstract：

INTRODUCTION:Pimavanserin is a selective 5-HT2A inverse agonist/antagonist approved for treating hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Results from short-term, placebo-controlled studies demonstrated a positive benefit/risk profile. This multi-year, open-label study assessed long-term safety and tolerability of pimavanserin. METHODS:This was an open-label extension (OLE) study in patients previously completing a double-blind, placebo-controlled study or a previous OLE study. Safety was evaluated from adverse events (AEs), clinical laboratory results, motor symptoms, electrocardiograms (ECG), and mortality. Durability of response was assessed from the Clinical Global Impression-Severity (CGI-S) scale and Caregiver Burden Scale (CBS). RESULTS:Of 459 participants treated in this OLE study (average age 71.2 years), the median duration of treatment was 454 days. Over the entire study period (approximately 11 years), ≥1 AE occurred in 392 (85.4%) patients; the majority were of mild to moderate intensity, with fall (32.0%), urinary tract infection (19.0%), and hallucination (13.7%) most common. Serious AEs occurred in 188 (41.0%) patients, and an AE leading to study termination or dose discontinuation occurred in 133 (29.0%) patients. Sixty-one patients died, 59 (12.9%) during treatment or within 30 days after the last dose of study drug; the observed mortality rate was 6.45 per 100 patient-years of exposure. Mean scores for the CGI-S scale and CBS generally remained stable for up to 192 weeks (>3.5 years). CONCLUSIONS:Long-term treatment with pimavanserin 34 mg once daily demonstrated a favorable benefit/risk profile with no unexpected safety concerns. Mortality rates suggested no increased risk following long-term treatment.

journal_name

Parkinsonism Relat Disord

journal_title

Parkinsonism & related disorders

authors

Ballard CG,Kreitzman DL,Isaacson S,Liu IY,Norton JC,Demos G,Fernandez HH,Ilic TV,Azulay JP,Ferreira JJ,Abler V,Stankovic S,015 Study Group.

doi

10.1016/j.parkreldis.2020.06.026

subject

Has Abstract

pub_date

2020-08-01 00:00:00

pages

100-106

eissn

1353-8020

issn

1873-5126

pii

S1353-8020(20)30203-0

journal_volume

77

pub_type

杂志文章

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