PMID- 28811926
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2056-4724 (Print)
IS  - 2056-4724 (Electronic)
IS  - 2056-4724 (Linking)
VI  - 3
IP  - 4
DP  - 2017 Jul
TI  - Postinjection delirium/sedation syndrome in patients with schizophrenia receiving 
      olanzapine long-acting injection: results from a large observational study.
PG  - 186-192
LID - 10.1192/bjpo.bp.116.004382 [doi]
AB  - BACKGROUND: Postinjection delirium/sedation syndrome (PDSS) has been reported 
      uncommonly during treatment with olanzapine long-acting injection (LAI), a 
      sustained-release formulation of olanzapine. AIMS: The primary aim of the study 
      was to estimate the incidence per injection and per patient of PDSS events in 
      adult patients with schizophrenia who were receiving olanzapine LAI in real-world 
      clinical practice. Secondary aims were to further characterise the clinical 
      presentation of PDSS events, to identify potential risk factors associated with 
      PDSS events and to characterise hospitalisations at baseline and post-baseline. 
      METHOD: A prospective observational study of adult patients with schizophrenia 
      receiving olanzapine LAI from 24 countries. Data were collected on patient 
      characteristics, olanzapine LAI treatment and any adverse events (AEs). All AEs 
      were reviewed and adjudicated for PDSS using predetermined criteria. RESULTS: 
      There were 46 confirmed PDSS events (0.044% of the 103 505 injections) in 45 
      patients (1.17% of the 3858 patients). Based on 45 confirmed events with 
      time-to-onset information, 91.1% (n=41) occurred within 1 h of injection. 
      Time-to-recovery from the event was within 72 h for 95.6% of patients (range 6 h 
      to 11 days). Risk factors for PDSS (per-injection) included high dose (odds ratio 
      (OR)(high/low)=3.95; P=0.006) and male gender (OR(female/male)=0.42; P=0.017). 
      CONCLUSIONS: Results of this study confirm previously reported PDSS rates, time 
      to onset and recovery, and the severity of PDSS events, and suggest that higher 
      doses and male gender are potential risk factors associated with PDSS. 
      DECLARATION OF INTEREST: All authors are full-time employees and hold stock/stock 
      options in Eli Lilly, which funded this study. This post-authorisation safety 
      study (PASS) was proposed by Eli Lilly when submitting the original marketing 
      authorisation application for olanzapine LAI in 2007. The protocol and final 
      study report for this European Union regulatory commitment are publicly 
      accessible via the European Network of Centres for Pharmacoepidemiology and 
      Pharmacovigilance (ENCePP) European Union PASS Register 
      (www.encepp.eu/encepp/viewResource.htm?id=16847). The current manuscript 
      describes the results within the final study report. COPYRIGHT AND USAGE: (c) The 
      Royal College of Psychiatrists 2017. This is an open access article distributed 
      under the terms of the Creative Commons Non-Commercial, No Derivatives (CC 
      BY-NC-ND) license.
FAU - Meyers, Kristin J
AU  - Meyers KJ
AD  - , MPH, PhD, Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Upadhyaya, Himanshu P
AU  - Upadhyaya HP
AD  - , MBBS, MS, MBA, Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Landry, John L
AU  - Landry JL
AD  - , MMath, Eli Lilly Canada, Toronto, Ontario, Canada.
FAU - Chhabra-Khanna, Rashna
AU  - Chhabra-Khanna R
AD  - , MD, Eli Lilly and Company, Windlesham, Surrey, UK.
FAU - Falk, Deborah M
AU  - Falk DM
AD  - , BS, Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Seetharama Rao, Balasubramanya
AU  - Seetharama Rao B
AD  - , MBBS, MRCPsych, MFPM, MSc, Eli Lilly and Company, Windlesham, Surrey, UK.
FAU - Jones, Meghan E
AU  - Jones ME
AD  - , MSPH, Eli Lilly and Company, Indianapolis, Indiana, USA.
LA  - eng
PT  - Journal Article
DEP - 20170810
PL  - England
TA  - BJPsych Open
JT  - BJPsych open
JID - 101667931
PMC - PMC5550823
EDAT- 2017/08/16 06:00
MHDA- 2017/08/16 06:01
PMCR- 2017/08/10
CRDT- 2017/08/17 06:00
PHST- 2016/11/30 00:00 [received]
PHST- 2017/07/11 00:00 [revised]
PHST- 2017/07/13 00:00 [accepted]
PHST- 2017/08/17 06:00 [entrez]
PHST- 2017/08/16 06:00 [pubmed]
PHST- 2017/08/16 06:01 [medline]
PHST- 2017/08/10 00:00 [pmc-release]
AID - S2056472400002234 [pii]
AID - bjporcpsych004382 [pii]
AID - 10.1192/bjpo.bp.116.004382 [doi]
PST - epublish
SO  - BJPsych Open. 2017 Aug 10;3(4):186-192. doi: 10.1192/bjpo.bp.116.004382. 
      eCollection 2017 Jul.