ALISO VIEJO, Calif.,
Dec. 1, 2015 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. today announced that
data on the prevalence of symptoms for pseudobulbar affect (PBA), a
distressing condition characterized by sudden and uncontrollable
outbursts of laughing and/or crying resulting from certain
neurologic diseases or brain injury (TBI), and the use of
antipsychotic medications in nursing home residents, were recently
published in the International Journal of Geriatric Psychiatry. The
study showed that almost one in 10 (9.0%) nursing home residents
had symptoms suggestive of PBA and that patients with PBA symptoms
were twice as likely to be receiving antipsychotic medications
(p=0.015) even though patients with the diagnosis of psychosis were
excluded from the sample assessed. In a subset of these residents
who had neurological disorders affecting the brain, 17.5% were
found to have symptoms suggestive of PBA.
"While the underlying conditions that can cause PBA are common
in nursing home residents, the prevalence of PBA symptoms in this
population has never been studied directly. This is the first study
that has allowed us to screen for PBA symptoms and then investigate
real-world treatment patterns, giving us some of the first insights
into the prevalence of PBA in nursing home residents," said
Joao Siffert, MD, chief medical
officer at Avanir. "It is critical that we have a better
understanding of the prevalence of PBA in this population given
that PBA is a treatable neurological condition that is often
confused with mood disorders or misdiagnosed. Better identification
and diagnosis of patients with PBA are important in the care of
nursing home residents."
"This study also showed that the use of antipsychotics in
nursing homes is higher in patients with PBA symptoms compared to
those without. Additional studies are needed, but these data
suggest potentially inappropriate off-label use of antipsychotic
medications in nursing home residents for the treatment of PBA,"
said Kevin Foley, MD, FACP, director
of education and clinical operations and associate professor,
division of Geriatric Medicine at Michigan
State University, Department of Family Medicine, College of
Human Medicine. "PBA diagnosis and management are important in this
patient population given the negative impact PBA can have on social
function, psychological well-being and quality of life. However,
overlap with co-morbid psychiatric disorders and depression pose
challenges for adequately identifying and managing PBA. As a
result, antipsychotics, anxiolytics, and other
psychopharmacological medications are often used to manage PBA
symptoms despite the lack of substantial evidence supporting their
off-label use for this condition."
About the Study Design
This observational study was
conducted between 2013 and 2014 and assessed 811 residents of nine
nursing homes in Michigan using
their Minimum Data Set (MDS), version 3.0 data in order to identify
the subset of residents at risk for PBA and to evaluate use of
psychotropic medications, including antipsychotics. A subset of
this sample (412 residents) was considered predisposed to PBA
symptoms if they had a documented diagnosis of a neurological
disorder associated with PBA, including dementia, stroke,
Parkinson's disease, multiple sclerosis as well as other
neurological conditions. Patients with an existing diagnosis of
psychosis, delirium or other disruptive behaviors were excluded. A
series of screening tools were used by a geropsychologist to assess
the predisposed population including the Center for Neurologic
Study-Lability Scale (CNS-LS), a research tool for the assessment
of PBA symptoms; a diagnostic evaluation checklist designed to
provide context for the potential PBA symptoms; and a chart review
to determine use of psychopharmacological medications. The
demographics of the resident population evaluated for this study
were similar to that of the overall nursing home population,
although there were significantly more patients with dementia in
the nursing homes evaluated in the study.
Study Results
Over half of the residents (51%) had a
neurologic condition known to be associated with PBA. Of this
population, 72 residents (17.5%) had a CNS-LS score of ≥13 (the
instrument's range for clinical PBA), which represents 9.0% of the
total nursing home resident population. Approximately twice as many
residents were prescribed antipsychotic medications (25.0%)
compared to residents without PBA symptoms (13.5%), despite the
fact that they had no diagnosis of psychosis. Similar results were
seen with anxiolytic medications with 25% of residents with PBA
symptoms receiving treatment compared to 14.1% of residents without
PBA symptoms. Antidepressant use was common in both groups but the
differences between those with and those without PBA symptoms was
not statistically significant (62.5% vs. 53.2%, p = 0.151).
About PBA
PBA is a neurologic condition characterized
by uncontrollable, disruptive laughing and/or crying outbursts that
are often contrary or exaggerated to the patient's inner mood
state. PBA occurs secondary to a variety of neurologic conditions
such as traumatic brain injury (TBI), multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS), Parkinson's disease, stroke
and Alzheimer's disease. When these disorders damage areas of the
brain that regulate normal emotional expression, they can lead to
uncontrollable, disruptive episodes of crying or laughing. For more
information about PBA, please visit www.PBAFacts.com.
About Avanir Pharmaceuticals, Inc.
Avanir
Pharmaceuticals, Inc. is a biopharmaceutical company focused on
bringing innovative medicines to patients with central nervous
system disorders of high unmet medical need. As part of our
commitment, we have extensively invested in our pipeline and are
dedicated to advancing medicines that can substantially improve the
lives of patients and their loved ones. For more information about
Avanir, please visit http://www.avanir.com.
Avanir is a subsidiary of Otsuka
America, Inc. (OAI), a holding company established in the
U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co.,
Ltd., a global healthcare company with the corporate philosophy:
'Otsuka-people creating new products for better health
worldwide.'
Otsuka Pharmaceutical is a leading firm in the challenging area
of mental health and also has products and research programs for
several under-addressed diseases including tuberculosis, a
significant global public health issue. These commitments
illustrate more powerfully than words how Otsuka is a "big venture"
company at heart, applying a youthful spirit of creativity in
everything it does.
Otsuka Pharmaceutical and its affiliates employ approximately
30,000 people globally, and the company welcomes you to visit its
global website at: http://www.otsuka.co.jp/en/index.php
Avanir® is a trademark or registered trademark of Avanir
Pharmaceuticals, Inc. in the United
States and other countries.
©2015 Avanir Pharmaceuticals, Inc. All Rights Reserved.
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SOURCE Avanir Pharmaceuticals, Inc.