PMID- 24423017
OWN - NLM
STAT- MEDLINE
DCOM- 20150902
LR  - 20211021
IS  - 1471-244X (Electronic)
IS  - 1471-244X (Linking)
VI  - 14
DP  - 2014 Jan 14
TI  - A pooled analysis of injection site-related adverse events in patients with 
      schizophrenia treated with olanzapine long-acting injection.
PG  - 7
LID - 10.1186/1471-244X-14-7 [doi]
AB  - BACKGROUND: Depot antipsychotic injections are an important tool for the 
      management of patients with schizophrenia who have difficulty with adherence to 
      oral medication. However, pain and discomfort at the injection site can be a 
      potential impediment to the use of these long-acting formulations. We report here 
      the results of a pooled analysis of injection site-related adverse events (AEs) 
      collected during treatment with the olanzapine long-acting injection (olanzapine 
      LAI). METHODS: Unsolicited injection site-related AEs were pooled from 7 
      olanzapine LAI clinical trials conducted in patients between March 2001 and 
      December 2010. All patients had a Diagnostic and Statistical Manual of Mental 
      Disorders, Fourth Edition (DSM-IV) or Fourth Edition, Text Revision (DSM-IV-TR) 
      diagnosis of schizophrenia or schizoaffective disorder and were between the ages 
      of 18 and 75. Doses ranged from 45 to 405 mg olanzapine LAI, and injection 
      intervals were 2, 3, or 4 weeks. Events were evaluated for severity, timing, 
      possible risk factors, and outcome. A criterion of p < .05 for statistical 
      significance was used for all tests. RESULTS: A total of 1752 patients received 
      at least 1 olanzapine LAI injection. Of these, 92 patients (5.3%) reported at 
      least 1 injection site-related AE, with "pain" being the most common type (2.9%). 
      Most events were mild (81.4%) and the median duration was 3 days. Four patients 
      (0.2%) discontinued due to injection site-related AEs. Dose volume and body mass 
      index did not appear to affect the probability of injection site-related AEs. 
      However, patients who experienced a post-injection delirium/sedation syndrome 
      event (n = 37) were more likely to have or have had an injection site-related AE 
      at some time during the study. Incidence of injection site-related AEs appeared 
      to decrease over time. In 94.2% of the injection site-related AEs, no specific 
      treatment or concomitant medication was reported; in 9 cases, patients received 
      pharmacologic treatment for reaction, mass, abscess, rash, or pain. CONCLUSIONS: 
      Injection site-related AEs with olanzapine LAI were generally mild. The incidence 
      and nature of these injection site-related AEs were generally similar to those 
      occurring during treatment with other injectable antipsychotics. TRIAL 
      REGISTRATION: ClinicalTrials.gov ID; URL: NCT00094640, NCT00088478, NCT00088491, 
      NCT00088465, and NCT00320489.
FAU - Atkins, Susan
AU  - Atkins S
AD  - Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, 
      Indianapolis, IN 46285, USA. atkins_susan@lilly.com.
FAU - Detke, Holland C
AU  - Detke HC
FAU - McDonnell, David P
AU  - McDonnell DP
FAU - Case, Michael G
AU  - Case MG
FAU - Wang, Shufang
AU  - Wang S
LA  - eng
SI  - ClinicalTrials.gov/NCT00088465
SI  - ClinicalTrials.gov/NCT00088478
SI  - ClinicalTrials.gov/NCT00088491
SI  - ClinicalTrials.gov/NCT00094640
SI  - ClinicalTrials.gov/NCT00320489
PT  - Journal Article
DEP - 20140114
PL  - England
TA  - BMC Psychiatry
JT  - BMC psychiatry
JID - 100968559
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 12794-10-4 (Benzodiazepines)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antipsychotic Agents/administration & dosage/*adverse effects
MH  - Benzodiazepines/administration & dosage/*adverse effects
MH  - Delayed-Action Preparations/administration & dosage/adverse effects
MH  - Delirium/chemically induced
MH  - Diagnostic and Statistical Manual of Mental Disorders
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Injections, Intramuscular/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Olanzapine
MH  - Pain/etiology
MH  - Psychotic Disorders/drug therapy
MH  - Risk Factors
MH  - Schizophrenia/*drug therapy
MH  - Young Adult
PMC - PMC3897927
EDAT- 2014/01/16 06:00
MHDA- 2015/09/04 06:00
PMCR- 2014/01/14
CRDT- 2014/01/16 06:00
PHST- 2013/03/29 00:00 [received]
PHST- 2014/01/09 00:00 [accepted]
PHST- 2014/01/16 06:00 [entrez]
PHST- 2014/01/16 06:00 [pubmed]
PHST- 2015/09/04 06:00 [medline]
PHST- 2014/01/14 00:00 [pmc-release]
AID - 1471-244X-14-7 [pii]
AID - 10.1186/1471-244X-14-7 [doi]
PST - epublish
SO  - BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.