PMID- 32712560
OWN - NLM
STAT- MEDLINE
DCOM- 20210906
LR  - 20210906
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 77
DP  - 2020 Aug
TI  - Long-term evaluation of open-label pimavanserin safety and tolerability in 
      Parkinson's disease psychosis.
PG  - 100-106
LID - S1353-8020(20)30203-0 [pii]
LID - 10.1016/j.parkreldis.2020.06.026 [doi]
AB  - INTRODUCTION: Pimavanserin is a selective 5-HT(2A) 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.
CI  - Copyright (c) 2020. Published by Elsevier Ltd.
FAU - Ballard, Clive G
AU  - Ballard CG
AD  - University of Exeter Medical School, Exeter, UK. Electronic address: 
      c.ballard@exeter.ac.uk.
FAU - Kreitzman, David L
AU  - Kreitzman DL
AD  - Parkinson's Disease and Movement Disorders Center of Long Island, Commack, NY, 
      USA.
FAU - Isaacson, Stuart
AU  - Isaacson S
AD  - Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, 
      USA.
FAU - Liu, I-Yuan
AU  - Liu IY
AD  - ACADIA Pharmaceuticals Inc., San Diego, CA, USA.
FAU - Norton, James C
AU  - Norton JC
AD  - ACADIA Pharmaceuticals Inc., San Diego, CA, USA.
FAU - Demos, George
AU  - Demos G
AD  - ACADIA Pharmaceuticals Inc., San Diego, CA, USA.
FAU - Fernandez, Hubert H
AU  - Fernandez HH
AD  - Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, 
      Cleveland, OH, USA.
FAU - Ilic, Tihomir V
AU  - Ilic TV
AD  - Medical Faculty of Military Medical Academy, Belgrade, Serbia.
FAU - Azulay, Jean-Philippe
AU  - Azulay JP
AD  - Timone Hospital, Marseille, France.
FAU - Ferreira, Joaquim J
AU  - Ferreira JJ
AD  - Faculty of Medicine, University of Lisbon, Lisbon, Portugal.
FAU - Abler, Victor
AU  - Abler V
AD  - ACADIA Pharmaceuticals Inc., San Diego, CA, USA.
FAU - Stankovic, Srdjan
AU  - Stankovic S
AD  - ACADIA Pharmaceuticals Inc., San Diego, CA, USA.
CN  - 015 Study Group
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200628
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperidines)
RN  - 8W8T17847W (Urea)
RN  - JZ963P0DIK (pimavanserin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Female
MH  - Hallucinations/drug therapy/etiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/complications/*drug therapy
MH  - Piperidines/*therapeutic use
MH  - Psychotic Disorders/*drug therapy/etiology
MH  - Urea/*analogs & derivatives/therapeutic use
OTO - NOTNLM
OT  - Parkinson's disease psychosis
OT  - Pimavanserin
OT  - Tolerability
EDAT- 2020/07/28 06:00
MHDA- 2021/09/07 06:00
CRDT- 2020/07/27 06:00
PHST- 2020/01/17 00:00 [received]
PHST- 2020/05/11 00:00 [revised]
PHST- 2020/06/23 00:00 [accepted]
PHST- 2020/07/28 06:00 [pubmed]
PHST- 2021/09/07 06:00 [medline]
PHST- 2020/07/27 06:00 [entrez]
AID - S1353-8020(20)30203-0 [pii]
AID - 10.1016/j.parkreldis.2020.06.026 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2020 Aug;77:100-106. doi: 
      10.1016/j.parkreldis.2020.06.026. Epub 2020 Jun 28.